Clinical Trials Logo
  1. Home
  2. Peripheral Arterial Disease
  3. NCT04706273
  4. Details
NCT04706273 Clinical Trial

GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)

Peripheral Arterial Disease Clinical Trial

Official title:
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04706273
Other study ID # JPS 16-03
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 25, 2016
Est. completion date December 14, 2022

Study information
Verified date May 2023
Source W.L.Gore & Associates
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will confirm device efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® Endoprosthesis for the treatment of symptomatic peripheral arterial disease in the superficial femoral arteries.

Recruitment information / eligibility
Status Completed
Enrollment 321
Est. completion date December 14, 2022
Est. primary completion date July 11, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Symptomatic peripheral arterial disease in superficial femoral artery lesions

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• GORE® VIABAHN® Endoprosthesis
On Day 1, Participants will receive the GORE® VIABAHN® Endoprosthesis

Locations
Country Name City State
Japan Kansai Rousai Amagasaki Hyogo

Sponsors (1)
Lead Sponsor Collaborator
W.L.Gore & Associates

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary Assisted Patency Primary assisted patency is defined as hemodynamic evidence of flow through a device that had not required a TLR to restore flow after total occlusion. Day 1 to Month 24
Primary Freedom from Revascularization Revascularization for restenosis or occlusion of the treatment lesion Day 1 to Month 24
Secondary Number of Serious Adverse Events Day 1 to Month 60
Secondary Rate of Stent Fractures Day 1 to Month 60
See also
  Status Clinical Trial Phase
Recruiting NCT06032065 - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD) Phase 3
Active, not recruiting NCT03987061 - MOTIV Bioresorbable Scaffold in BTK 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
Active, not recruiting NCT04677725 - NEtwork to Control ATherothrombosis (NEAT Registry)
Recruiting NCT05961943 - RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients N/A
Recruiting NCT06047002 - Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
Completed NCT03185052 - Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach N/A
Recruiting NCT05992896 - A Study of Loco-Regional Liposomal Bupivacaine Injection Phase 4
Completed NCT04635501 - AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial N/A
Recruiting NCT04584632 - The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery N/A
Withdrawn NCT03994185 - The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease N/A
Withdrawn NCT03538392 - Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
Recruiting NCT02915796 - Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty Phase 1
Active, not recruiting NCT02900924 - Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
Completed NCT02901847 - To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities. N/A
Withdrawn NCT02126540 - Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries N/A
Not yet recruiting NCT02387450 - Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication Phase 2/Phase 3
Not yet recruiting NCT02455726 - Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease N/A
Completed NCT02384980 - Saving Life and Limb: FES for the Elderly With PAD Phase 1