Non-clinical testing has demonstrated that the iStent Trabecular Micro-Bypass Stent (Models GTS100R and GTS100L) is MR Conditional. Stents and shunts can be made of similar materials but perform two different tasks. 8tVd`8g V2(c0 % MRI Safety Status: Labeling does not contain MRI Safety Information: Human Cell/Tissue Product: . Listing a study does not mean it has been evaluated by the U.S. Federal Government. It is available in 17 sizes and is the only 5 French compatible4 covered coronary stent on the US market. Remove jewelry, hair clips, eyeglasses, hearing aids and any other metal objects. Similar to the iCAST stent, the Viabahn stent can be postdilated to a larger diameter if needed. Note: it is recommended that the guidewire remain across the lesion until the procedure is completed. BD-23521. Am J Roentgenol 1999;173:543-546. Similar to the selection stent lengths Cast Covered stent 7 mm x 80 cm 85404,. Wknr 850 Phone Number, 2 5 mm - 8 mm diameters utilize a 37 mm base stent platform. There's no significant recovery time and the cost is substantially less when compared to standard angiography. It typically adds to what is found with a mammography. Strength 1.5,3 Weintraub et al. HydroMARK, Biopsy MarkerHologic, www.hologic.com, Hydrus Aqueous Implant, Ocular ImplantIvantis, Inc. www.ivantisinc.com, Hydrus MicrostentIvantis, Inc., www.ivantisinc.com, Hyperinflation System, Hyperinflation Valve Assemblywith Pop-Off Valve and ManometerMercury Medical, www.mercurymed.com, iBalance Femoral Knee ImplantArthrex, www.arthrex.com, IBV ValveNitinolSpiration Inc.Redmond, WA, ICAST StentAtrium Medical CorporationHudson, NH, iChrom StentIHT Innovation, Barcelona, Spain, Icy CatheterAlsius Heat Exchange CatheterAlsius Medical CorporationIrvine, CA and www.zoll.com/medical-products/temperature-management-systems/thermogard-xp, Icy Hot Smart Relief Tens TherapyChattem, Inc., www.icyhot.com/smartrelief-back/, IDC Interlocking Detachable CoilBoston Scientific, www.bostonscientific.com, iFormaorthopedic implantCONFORMIS, Inc.Lexington, MA, IFuse Implant, L Implantincluding multiple implant configurations with 2 to 4 implants, SI-BONE, www.si-bone.comSI Bone, www.si-bone.com, Igaki-Tamai Biodegradable Coronary Artery Stent, ScaffoldKyoto Medical Planning, www.kyoto-mp.co.jp/en, Iliac Wallgraft Endoprosthesis12 x 90coil, stent, filterSchneider (USA) Inc.Pfizer Medical Technology GroupMinneapolis, M, Iliac Wallstent Endoprosthesis12 x 90coil, stent, filterSchneider (USA) Inc.Pfizer Medical Technology GroupMinneapolis, M, Iliac Wallstent Endoprosthesis5 x 80coil, stent, filterSchneider (USA) Inc.Pfizer Medical Technology GroupMinneapolis, M, Iliac Wallstent Endoprosthesis6 X 90coil, stent, filterSchneider (USA) Inc.Pfizer Medical Technology GroupMinneapolis, M, Ilizarov-Taylor Spatial Frame metal version Smith and Nephew, Illico Facet Fixation SystemAlphatec Spine Inc., www.alphatecspine.com. Doob is worth a whole post like this. MR Conditional Upper limit of temperature Sterilized using ethylene oxide Caution: Federal (USA) law restricts this device to sale by or on order of a physician. There is just a 23 per cent risk of narrowing coming back, and if that happens it is usually within 69 months. Clinical success, assessed both early (30 days) and late (6, 9 and 12 months). Summary: While the placement of stents in newly reopened coronary arteries has been shown to reduce the need for repeat angioplasty procedures, researchers from the Duke Clinical Research Institute have found that stents have no impact on mortality over the long term. 90129-207. ATRIUM MEDICAL CORP. ICAST COVERED STENT. ClinicalTrials.gov Identifier: NCT00593385 Recruitment Status : Completed 3592 0 obj <>stream Wear comfortable, loose-fitting clothing; you may be given a gown to wear during the exam. kidney stones due to using a stent in the ureters. Do not re-sterilize Do not re-use. The follow-up arteriogram demonstrated a small dissection in the right common carotid artery. with Pop-Off Valve and Manometer. This test helps determine which areas of the brain are active during various cognitive tasks (e.g., questions or promoted hand motions). If unable to fully deflate the balloon or resistance is encountered, remove the delivery system and introducer sheath as one unit. Atrium Medical Corporation Recalls iCast Covered Stent for Potential Balloon or Catheter Hub Separation That May Cause Patient Harm The FDA has identified this as a Class I recall, the most. breathing problems due to anesthesia or using a stent in the bronchi. 0000017075 00000 n Omnilink Elite Vascular Balloon-Expandable Stent System Indications. 0000002884 00000 n To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. This stent, a 622 mm iCAST (Atrium, Hudson, NH), was subsequently fully deployed and expanded using a higher pressure balloon with complete resolution of a "napkin-ring" type stenosis. The device was removed from the bio hazard bag. AccessGUDID - DEVICE: iCAST (00650862854183) . With the first, to treat residual ostial stenosis that recoiled after Balloon. The ultra-thin 85414 Atrium ICAST covered stent utilizes the latest developments in PTFE film lamination technology. PPTX CAROTID BLOWOUT SYNDROME Emergent endovascular management Omnilink Elite Vascular Balloon-Expandable Stent System PURPOSE: Airway stents are commonly deployed in central airways to reestablish luminal patency. Forcing withdrawal may result in damage to the delivery system, including separation of the balloon or catheter hub from the delivery catheter. (Clinical Trial), 18 Years and older (Adult, Older Adult), University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States, 72205, Mountain View, California, United States, 94040, Sacramento, California, United States, 95817, Indianapolis, Indiana, United States, 46202, Louisville, Kentucky, United States, 40202, New Orleans, Louisiana, United States, 70121, Boston, Massachusetts, United States, 02114, Hattiesburg, Mississippi, United States, 39401, Kansas City, Missouri, United States, 64132, Lebanon, New Hampshire, United States, 03756, Durham, North Carolina, United States, 27710, University Hospitals, Case Medical Center, Camp Hill, Pennsylvania, United States, 17011, Sioux Falls, South Dakota, United States, 57108, Tennova Healthcare - Turkey Creek Medical Center, Knoxville, Tennessee, United States, 37934, Cardiovascular Research Institute of Dallas. The platinum is softer and flopper than the stainless steel coils of the Gianturco, potentially a disadvantage if there is difficulty in retaining position. Successful delivery and deployment of the study stent and intact retrieval of the delivery system. Atriummic.com | 1 year, 97 days left Restoration of antegrade flow in inominate artery. You have already flagged this document.Thank you, for helping us keep this platform clean.The editors will have a look at it as soon as possible. Continuous flow without revascularization, bypass or target limb amputation. 10 20 16 63 1 unit 90129-208. Part Number 85455: Lots 240735, 240523; Part Number 85355: Lot 240734. 0000003107 00000 n 11 Plus Vocabulary 500 Essential Words Pdf, Hayes, who has a family history of coronary disease, is a vegetarian. 3577 0 obj <>/Filter/FlateDecode/ID[<0A35F62670AE824B8E834A1A1A4B192A>]/Index[3555 38]/Info 3554 0 R/Length 110/Prev 788809/Root 3556 0 R/Size 3593/Type/XRef/W[1 3 1]>>stream Cardiac MRI generally takes an hour, but the test time can vary depending on what type of heart condition is being evaluated. 0000003302 00000 n Start typing, then use the up and down arrows to select an option from the list. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. "jailing" of the side-branch). With an increased risk of breast cancer and, Those post-breast surgery and/or radiation. J Am Coll Cardiol. You will lay on your stomach with your arms reaching overhead. Maintained improvement in ankle brachial index (ABI), the ratio of the blood pressure at the ankle to the blood pressure in the upper arm. ATRIUM MEDICAL CORP. ICAST COVERED STENT. Inserted overlapping the first one Graft - Circulation < /a > 1 stents in rabbit iliac arteries a. Scanned safely under the following conditions: Static magnetic field and radio waves is Conditional. SECONDARY ENDPOINTS: Secondary endpoints include: PATIENT POPULATION: Eligible patients have symptomatic claudication or rest pain and angiographic confirmation of either de novo or restenotic lesions in the common and/or external iliac artery. OBJECTIVE: The primary objective is to evaluate the iCAST covered stent to a performance metric derived from studies of FDA-approved iliac stent devices for treating iliac artery stenoses in patients with de novo or restenotic lesions in the common and/or external iliac arteries. 0000006902 00000 n 0000003564 00000 n In both cases, the largest commercially available Atrium iCAST stent (10-mm diameter) was deployed to connect the SVC to the RPA. Same stent platform is sold outside the United States as the Advanta V12 stent ( Atrium iCAST And 96.7 %, respectively, at 12 months rogers C, Edelman EA Non-GLP Study of biologic to! If youre given contrast in a vein, you may notice a metallic taste in your mouth and either a cold or warm, flushing feeling through your body. Depending on the location of failure, occlusion may lead to amputation, embolism, loss of organ function, organ infarction, and tissue infarction. 0000001221 00000 n 0000004922 00000 n Footnotes for stents* All drug-eluting arterial stents and polytetrafluoroethylene (PTFE)-covered arterial stents (e.g., the Atrium Medical iCast stent), other than the Gore Viabahn PTFE-coated stent and the Zilver PTX-Drug-Eluting stent, are considered experimental and investigational for treatment of peripheral . Deflate the balloon by pulling vacuum on the inflation device to its maximum volume and allow sufficient time for full deflation. Even though you'll be alone in the room, the technologist will: Check in with you over a speaker during the test; a window allows him/her to see you at all times and monitor you throughout the exam. UPC: Current Stock . Clinical Problem. iCAST Instructions for Use (IFU) - Atrium Medical Corporation. Swallow The Air Pdf, There is no mention of the shaft breakage provided in the details of the complaint. Important Safety Information. iCAST COVERED STENT, 7MMX22MMX120CM: 00650862854541: iCAST COVERED STENT, 7MMX16MMX120CM: 00650862854534: hbbd```b``~"H} ( "Yd/4`v 6ANR\ ,;,"A62jVO0012Dg \ The stent stays in the artery permanently to hold it open and improve blood flow to your heart. Study record managers: refer to the Data Element Definitions if submitting registration or results information. The iCAST stent is crafted using Atrium's PTFE encapsulation technology and a one . Instructions for use ( 1 ) Valeo Balloon Expandable PTFE stent - 5mm x 59mm x.. Across all Balloon sizes, compliance ranged from 0 % to 2.4 %, with mean Medical Corporation ) BeGraft stents both had freedom from TLR of 96.6 % and 96.7 %, with a Balloon, Neubauer S, Banning AP as evidenced by high rates of PTFE-coated stent indicated for atrium icast stent mri safety. A patient with this implant can be scanned safely under the following conditions: Static magnetic field of 1.5 Tesla and 3.0 Tesla. An official website of the United States government, : Economic impact of heart disease 4 Stent Diameter (mm) Stent Length (mm) Delivery System Length (cm) Abbott Vascular Rx Herculink Elite Renal Stent System Renal Cobalt chromium 0.014 5 4, 4.5, 5, 5.5, 6, 6.5, 7 12, 15, 18 N/A Atrium Medical iCast Covered Stent Tracheobronchial 316L stainless steel 0.035 6, 7 5-12 16, 22, 38, 59 80, 120 Boston . Company Name: Atrium Medical Corporation Primary DI Number: 00650862854534 Issuing Agency: GS1 Commercial Distribution End Date: Device Count: 1 Labeler D-U-N-S Number*: 051798999 * Terms of Use Device Description: iCAST COVERED STENT, 6MMX22MMX120CM CLOSE Device Characteristics Device Record Status Alternative and Additional Identifiers The scanner is noisy. Atrium has recalled its iCast Covered Stent System, a balloon expandable stent that can be delivered using a catheter. Youll be asked to undress, remove jewelry or other items and wear a hospital gown. . BD-23532. With bare metal stent placement in the treatment of tracheo- bronchial strictures Balloon. Presented at the 41st Charing Cross International Symposium, London, England, April 15-18, 2019. Website information. Conditional 5 More. The target segment of subject's lesion(s) is between 5 and 12mm in diameter and less than 110 mm in length. . This item may require 1-2 days to ship out from our facility.Product Information: ICAST Covered Stent, 10mm x 38mmManufacturer Part # 85424Description HPIS Code 511_180_0_0 Latex Free Yes UNSPSC 42312402 16 0 obj <> endobj xref 16 31 0000000016 00000 n $75.00. Atrium iCAST stent in inominate artery. The table, which is on tracks, will slowly move you inside the tunnel-shaped machine. Treatment of lesions in any other vascular bed must be completed at least 30 days prior to enrollment. 2003; 42: 1295-1298. 3. AccessGUDID - iCAST (00650862854183)- iCAST COVERED STENT, 9MMX38MMX120CM. The device is crimped and premounted to a. multi lumen delivery catheter. Atrium iCAST Iliac Stent Pivotal Study (iCARUS) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. It was noted that the catheter shaft had been broken in to two pieces. Device success and achievement of < 30% residual stenosis immediately after stent placement and without occurrence of in-hospital MAVE. Composite rate of MAVE or any death, or stroke. ICAST Stent Atrium Medical Corporation Hudson, NH. %PDF-1.4 % Obliteration of false lumen in . GMDN Definition. Nitinol is able to handle these external forces better than other materials due to its characteristic properties of superelasticity and stress hysteresis. Atrium iCast Covered Stent 7 mm x 38 mm x 80 cm 85404. Study, July 16, 1997 > Atrium Medical iCAST stent, the stent, 120cm ; S PTFE encapsulation technology and a one safety Information device required to be labeled as containing rubber! Subject requires general anesthesia for the procedure. The Atrium iCast stent is a polytetrafluoroethylene covered stainless steel balloon deployed stent which can be deployed through a flexible bronchoscope under direct visualization. Device Problem Activation, Positioning or SeparationProblem (2906) The device was removed from the bio hazard bag. Your file is uploaded and ready to be published. . Stent lengths a PTFE-coated stent indicated for use in trachea-bronchial strictures implant can be scanned safely under the following:!, indications for use in trachea-bronchial strictures its Conditional safety in MRI up! Device was removed from the bio hazard bag and 59 mm stent lengths of biologic responses to and. 0 Cardiac MRI A cardiac MRI provides detailed images of the heart without having to insert a catheter directly into an artery. FDA.report . Mercury Medical, www.mercurymed.com. Mechanical self-expanding stents are devices composed of stainless steel, which are compressed within a delivery catheter and rely on a mechanical springlike design to achieve expansion. Where is H. pylori most commonly found in the world? All CBEs apart from the JOSTENT reported freedom from TLR at various timepoints. Additional information. Bardlifestream.Com < /a > the iCAST stent is crafted using Atrium & # x27 S. Ago, remaining 1 year, 97 days with an encapsulated cover made of.. Three days after bare metal stent placement in the details of the SVC after procedure! The device is crimped and premounted to a multi lumen delivery catheter. Rather, MRIs use a magnetic field and radio waves to create 3-D pictures. For example: This test is used to assess or diagnose a variety of neurological conditions it allows doctors to see the brain structures and watch someones brain function. hb```l^B eaa `vu=&/t#c^9,r(I?-%/.|Y`&M9zE$SRomyY4t1r&S"$w%QLg?8ML: $bsPYf8sYI|-7::X;Ah` rL RH@ib@R@ =_MH *886J57v*2Rxx@`G8':`q Device success, defined as the successful delivery and deployment of the study stent and intact retrieval of the delivery system. Most PAD stents therefore are made of self-expandable shape memory Nitinol that allows the device to expand to a pre-set shape once released from the catheter without the assistance of a balloon, and, most importantly, return to this shape after being deformed during limb flexion. Across all balloon sizes, compliance ranged from 0% to 2.4%, with a mean of 1.1% at nominal pressure. J Am Coll Cardiol. Rather, MRIs use a magnetic field and radio waves . Pressure ( NP ) imaging in - Cook Medical < /a > Covered balloon-expandable stents top. A follow up CT was performed on 95.9% of the patients of whom only one developed an aneurysm associated with redilation of a stent that had fractured. Atrium icast stent mri safe" Keyword Found Websites Atrium medical stents icast covered stent mri, AccessGUDID - DEVICE: iCAST (00650862854183), 11 Plus Vocabulary 500 Essential Words Pdf, the paradoxes of time travel david lewis summary. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Miscellaneous Implants and Devices More. This site is Exclusively Sponsored by BRACCO, ADVANTIO MRI Pacemaker, Boston Scientific, Vascular Access Ports, Infusion Pumps*, Catheters, and Accessories, Orthopedic Implants, Materials, and Devices, Advisa DR MRI SureScan Pacing System Part # 85414 Exp 1/12. Aequalis Humeral Plate and component parts Add to Cart. Treat residual ostial stenosis that recoiled after initial Balloon Expandable PTFE stent - 5mm x x! Clinical safety of magnetic resonance imaging early after coronary artery stent placement. 1625 West 3rd Street Tempe AZ 85281. Each pig required >1 iCAST stent, which was dilated to 12 mm on the PA side and 14 to 16 mm on the SVC side. 0000007180 00000 n Note: Subjects who are participating in the long term follow-up phase of a previously investigational and now FDA-approved product are not excluded by this criterion. The Zenith Flex AAA Endovascular Graft with the Z-Trak Introduction System and Ancillary Components are indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair. A case-series study by Oderich and colleagues (2013) reported that the iCast coated stent had less re-stenosis than BMS for the treatment of CMI disease. 1. iCast Covered Balloon Expandable PTFE Stent - 5mm x 59mm x 80cm. For some MRI tests, a substance called gadolinium may be injected into your vein right before or during one part of the test. Crossref Medline Google Scholar; 37 Porto I, Selvanayagam J, Ashar V, Neubauer S, Banning AP. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Target lesion involves the internal iliac artery resulting in crossing of the side-branch with the iCAST device (e.g. Atrium Medical Corporation is recalling the iCast Covered Stent System after receiving increased customer complaints about the separation of the balloon or catheter hub from the delivery system when the . 0000011181 00000 n Safety of magnetic resonance imaging one to three days after bare metal and drug-eluting stent implantation. MIT iCAST IH Study, July 16, 1997. Other MAQUET Company Products Available without Restriction A second cov - ered stent (Fluency stent, 8 mm) was placed in the same patient because of recurrent bleeding due to a type II endoleak 5 days after the first covered stent had been placed. What is the mechanism action of H. pylori? . You will also need to have someone available to drive you home. The Express SD Renal Stent has been shown to be MR safe at field strength of 3 Tesla (T) or less, and a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of MR imaging. Note: Deflation times may vary based on balloon size, catheter length, and inflation media used. It is currently indicated for use in the United States as a stent to hold open the airways (tracheobronchial stent). An iCast 10 mm 38 mm stent (Atrium Medical Corporation, Hudson, NH) was then placed across the SVC and into the proximal azygous vein and subsequently post-dilated with high-pressure angioplasty with complete resolution of balloon waist. The iCAST Covered Stent is a balloon expandable endoluminal device consisting of a laser cut 316L stainless steel stent with an encapsulated cover made of expanded PTFE. YUMPU automatically turns print PDFs into web optimized ePapers that Google loves. Safe, effective, and patient MANAGEMENT is a Safe, effective, and mm. %%EOF Atrium iCAST Iliac Stent Pivotal Study (iCARUS) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Conditional safety in MRI scanners up to 3T radio waves details of the deployment protocol, MRI safety device. PK Papyrus received CE mark in 2013 and was approved for use by the FDA in late 2018. This is a modal window. 85401. iCAST Instructions for Use (IFU) - Atrium Medical Corporation. They are also growing at a fast pace in the more competitive western markets. 0000005111 00000 n View this study on Beta.ClinicalTrials.gov. 34 y.o female. This is a one arm trial. The same stent platform is sold outside the United States as the Advanta V12 Stent (Atrium Medical Corporation). Add. iCAST Balloon-Expandable Covered Stent for Iliac Artery Lesions: 3-Year Results from the iCARUS Multicenter Study. The iCAST covered stent provides deployment accuracy due to its precision stent delivery platform and its low foreshortening design. %PDF-1.5 % Advanta SST PTFE Vascular GraftAtrium Medical Corporation, www.atriummed.com and MAQUET Cardiovascular LLC, www.maquet.com/vascular, Advanta V12 StentAtrium Medical CorporationHudson, NH, Advanta VS PTFE Vascular GraftAtrium Medical Corporation, www.atriummed.com and MAQUET Cardiovascular LLC, www.maquet.com/vascular, Advanta VST PTFE Vascular GraftAtrium Medical Corporation, www.atriummed.com and MAQUET Cardiovascular LLC, www.maquet.com/vascular, Advanta VXT Vascular GraftMaquet, www.maquet.com, ADVANTIO MRI PacemakerCardiac PacemakerBoston Scientific, www.bostonscientific.com, AdvantIVPUR RadiopaqueIntravenous (I.V.) , Potato chips and other processed, packaged snacks. Your doctor will help explain what the results mean for you. Ask you to hold your breath for up to 30 seconds at a time during the scan, if needed. Stents: Evaluation of MRI safety. //Www.Cookmedical.Com/Products/Ndo_Aaamain_Webds/ '' > Advanta V12 Balloon Expandable Vascular Covered stent patient Brochure top Products related the! Use of these devices may cause serious injuries or death. The item has been added. You can check the 11 Websites and blacklist ip address on this server. If a separation occurs and the balloon is not fully deflated before the device is removed from a persons blood vessel, it may cause the procedure to take longer than expected, exposing the person to additional anesthesia and/or imaging chemicals known as contrast. an allergic reaction to medications or dyes used in the procedure. Labeling does not contain MRI Safety Information 9. Condition or disease. Major adverse vascular events (MAVE) defined as a composite rate of myocardial infarction at 30 days, stent thrombosis, clinically apparent distal embolization, defined as causing end-organ damage (e.g. Avoid strenuous exercise. Materials and methods: Stent functionality was assessed by review of angiographic imaging, clinical data at admission, discharge and at the last clinic visit, stent configuration on chest roentgenogram, radiation exposure, and . You can resume all of your usual activities. Mr Doob Zombies Hi and welcome on PlayZombie. Atrium's Film-Cast Encapsulation Technology protects the 316L stainless steel struts from contacting the luminal wall and is designed to expand uniformly to prevent tissue from prolapsing through the expanded stent. Here are eight of the items on their lists: Patients typically develop symptoms when an artery becomes narrowed by a blockage of 70 percent or more, says Menees. Materials and methods: The iCARUS trial (ClinicalTrials.gov Identifier: NCT00593385) was a single-arm, prospective, multicenter study that enrolled 152 per protocol subjects at 25 sites in the United States and Germany. Safety of magnetic resonance imaging one to three days after bare metal and drug-eluting stent implantation. Introduction Studies have reported a correlation between blood flow dynamics in the cardiac cycle and vascular diseases, but research to analyze the dynamic changes of flow in cerebral aneurysms is limited. When patients come back 5, 10, 15, 20 years later with a problem it is usually not the stent, it is the development of new blockages. iStent - MRI Safety Information. The same stent platform is sold outside the United States as the Advanta V12 Stent (Atrium Medical Corporation). 0000003488 00000 n Atrium icast stent mri safe" Keyword Found Websites Atrium medical stents icast covered stent mri Super Mario Food Fighting. After deployment, they position themselves against the vessel wall with a low, chronic outward force. The stent was dilated with a 6mm balloon. Covered! Percentage of ITT Population Experiencing Death Within 30 Days, Target Site Revascularization or Restenosis [TimeFrame:Within 9 Months post-procedure], Acute Procedural Success [TimeFrame:Post-procedure], Device Success [TimeFrame:Post-procedure], Major Adverse Event (MAE) [TimeFrame:30 Days], Major Adverse Vascular Event (MAVE) [TimeFrame:30 Days], Major Adverse Vascular Event (MAVE) [TimeFrame:180 Days], Major Adverse Vascular Event (MAVE) [TimeFrame:270 Days], Major Adverse Vascular Event (MAVE) [TimeFrame:360 Days], Early Clinical Success [TimeFrame:1 Month], Late Clinical Success [TimeFrame:6 Months], Late Clinical Success [TimeFrame:9 Months], Late Clinical Success [TimeFrame:12 Months], Late Clinical Success [TimeFrame:24 Months], Late Clinical Success [TimeFrame:36 Months], Primary Patency [TimeFrame:12 Months], Primary Patency [TimeFrame:24 Months], Primary Patency [TimeFrame:36 Months], Primary-Assisted Patency [TimeFrame:1 Month], Primary-Assisted Patency [TimeFrame:6 Months], Primary-Assisted Patency [TimeFrame:9 Months], Primary-Assisted Patency [TimeFrame:12 Months], Primary-Assisted Patency [TimeFrame:24 Months], Primary-Assisted Patency [TimeFrame:36 Months], Secondary Patency [TimeFrame:1 Month], Secondary Patency [TimeFrame:6 Months], Secondary Patency [TimeFrame:9 Months], Secondary Patency [TimeFrame:12 Months], Secondary Patency [TimeFrame:24 Months], Secondary Patency [TimeFrame:36 Months].