Clinical Trials Logo

Clinical Trial Summary

Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)


Clinical Trial Description

This is an Observational, prospective, single-arm, multicenter, post-market registry to collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) for one of the following indications: Iliac, Superficial Femoral Artery (SFA), Superficial Femoral Artery In-stent restenosis (SFA ISR), Hemodialysis access (AV access), Visceral artery aneurysms (VAA), Trauma/Injury, Popliteal Artery Aneurysms (PAA), or Other. Approximately 35 sites in Europe will participate and a minimum of 614 patients will be enrolled in this registry. All consecutive patients meeting protocol selection criteria, consented, with an intention to be treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX) will be included and followed through one year for Trauma/Injury and other; three years for VAA; five years for Iliac, SFA, SFA ISR and AV access and ten years for PAA per institutional standard of care. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04907240
Study type Observational [Patient Registry]
Source W.L.Gore & Associates
Contact Alexandre Figard
Phone +33 6 08 02 42 91
Email afigard@wlgore.com
Status Recruiting
Phase
Start date October 9, 2021
Completion date October 2035

See also
  Status Clinical Trial Phase
Not yet recruiting NCT05712395 - The Effects of a Novel, Non-ischemic and Pain-free Exercise Intervention in Peripheral Artery Disease N/A
Active, not recruiting NCT04534257 - Prospective Registry to Investigate the Safety and Efficacy of the Treatment With the Selution Sirolimus Drug Coated Balloon in TASC C and D Atheroma-occlusive Infra-Inguinal Disease in Patients With Chronic Limb Threatening Ischemia From Singapore N/A
Recruiting NCT04511234 - Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease N/A
Recruiting NCT03506633 - Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients N/A
Active, not recruiting NCT03506646 - Dietary Nitrate Supplementation and Thermoregulation N/A
Completed NCT02554266 - Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries
Completed NCT03921905 - Peripheral Artery Disease in Patients With Stable Coronary Artery Disease in General Practice: Prevalence, Management and Clinical Outcomes.
Not yet recruiting NCT06369350 - Vitamin B6 on Exercise Pressor Reflex on Leg Ischemia-reperfusion Early Phase 1
Recruiting NCT04545268 - Prehabilitation for Cardiac Surgery in Patients With Reduced Exercise Tolerance N/A
Recruiting NCT02389023 - Comparison of Prevena Negative Pressure Incision Management System vs. Standard Dressing After Vascular Surgery N/A
Completed NCT02563535 - Evaluation of the Use of ACOTEC Drug-Eluting Balloon Litos ® in Below-The-Knee Arteries to Treat Critical Limb Ischemia Phase 4
Completed NCT02539940 - Elutax-SV Drug-eluting Balloons for Below-the-knee Treatment
Completed NCT02542267 - In-Stent Restenosis Post-Approval Study N/A
Completed NCT02522884 - Tack Optimized Balloon Angioplasty Study of the Tack Endovascular Systemâ„¢ in Femoropoliteal Arteries N/A
Completed NCT02145065 - First-in-man Evaluation of a Novel, Microcrystalline Paclitaxel Coated Balloon for Treatment of Femoropopliteal Artery Disease (PAX-r) N/A
Completed NCT02228564 - BARD® Study of LIFESTREAMâ„¢ Balloon Expandable Covered Stent Treating Iliac Arterial Occlusive Disease N/A
Completed NCT02262949 - A Prospective Study of the Bard® LifeStent® Solo Vascular Stent System N/A
Completed NCT01743872 - Optical Imaging Measurement of Intravascular Solution Efficacy Trial N/A
Recruiting NCT01424020 - Walking Estimated Limitation Calculated by History - Study 2 Phase 4
Active, not recruiting NCT01597453 - NOR-SYS: The Norwegian Stroke in the Young Study N/A