Clinical trials: completed, sponsored by W.L.Gore & Associates
Aortic Dissection
ARISE: Evaluation of the GORE® Ascending Stent Graft in the Treatment of DeBakey Type I/II Aortic Dissection
Assess the feasibility of the treatment of DeBakey Type I/II aortic dissections with the GORE® Ascending Stent Graft
- Trial name
- NCT02380716
- Testing
- GORE® Ascending Stent Graft
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- W.L.Gore & Associates
Atrial Septal Defect
Safety and Efficacy Study of Transcatheter Closure of Ostium Secundum ASDs
Evaluate the safety and efficacy of the GORE® CARDIOFORM ASD Occluder in the percutaneous closure of ostium secundum atrial septal defects (ASDs)
- Trial name
- ASSURED (NCT02985684)
- Testing
- GORE® CARDIOFORM ASD Occluder
- Where
- 22 sites in United States
- Volunteers
- 125 people
- Sponsor
- W.L.Gore & Associates
PAD - Peripheral Arterial Disease, AAA - Abdominal Aortic Aneurysm
Retrospective Post-Market Clinical Follow-Up Study of GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft in Peripheral Artery Disease, Aortic Aneurysms, and Dialysis Access
This multicenter, single-arm retrospective registry (chart review) is being conducted to confirm the clinical performance and safety of GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft throughout the device functional…
- Conditions
- PAD - Peripheral Arterial Disease, AAA - Abdominal Aortic Aneurysm, End-Stage Renal Disease
- Trial name
- NCT05124184
- Testing
- GORE® PROPATEN® Vascular Graft, GORE-TEX® Vascular Grafts
- Where
- 8 sites in France, Italy and 1 more
- Volunteers
- 356 people
- Sponsor
- W.L.Gore & Associates
Vascular Stent-Graft Stenosis
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study
This study will confirm the efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® stent graft (hereafter referred to as "Viabahn") for the treatment of patients with stenosis or occlusion at the…
- Trial name
- NCT04429243
- Testing
- GORE® VIABAHN® Stent Graft
- Where
- 17 sites in Japan
- Volunteers
- 124 people
- Sponsor
- W.L.Gore & Associates
Thoracic Aortic Aneurysm, Thoracic Aorta Injury
CTAG Dissection/Trauma Post Marketing Surveillance Japan
Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis
- Conditions
- Thoracic Aortic Aneurysm, Thoracic Aorta Injury, Thoracic Aortic Dissection
- Trial name
- NCT05414318
- Testing
- Conformable GORE® TAG® Thoracic Endoprosthesis
- Volunteers
- 55 people
- Sponsor
- W.L.Gore & Associates
Peripheral Arterial Disease
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)
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.
- Trial name
- NCT04706273
- Testing
- GORE® VIABAHN® Endoprosthesis
- Where
- Japan
- Volunteers
- 321 people
- Sponsor
- W.L.Gore & Associates
Aortic Aneurysm, Abdominal
Evaluation of the GORE® C3 Delivery System Module
This is an observational Registry designed to obtain early data on the use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System.
- Trial name
- NCT01398332
- Testing
- Stent graft (EXCLUDER)
- Where
- Germany
- Volunteers
- 399 people
- Sponsor
- W.L.Gore & Associates
Aortic Aneurysm, Thoracic, Descending Thoracic Aortic Dissection
GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry
This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® TAG® Thoracic Endoprosthesis treating diseases of the thoracic aorta.
- Conditions
- Aortic Aneurysm, Thoracic, Descending Thoracic Aortic Dissection, Aortic Diseases, Aorta Thoracic; Traumatic Rupture
- Trial name
- NCT02266342
- Testing
- GORE® TAG® Thoracic Endoprostheses
- Where
- France
- Volunteers
- 154 people
- Sponsor
- W.L.Gore & Associates
Peripheral Artery Disease, Vascular Disease
In-Stent Restenosis Post-Approval Study
The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral Artery.
- Trial name
- NCT02542267
- Testing
- Gore VIABAHN Endoprosthesis
- Where
- 23 sites in United States, Germany and 2 more
- Volunteers
- 108 people
- Sponsor
- W.L.Gore & Associates
Thoracoabdominal Aortic Aneurysm
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms
This study will assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of Aortic Aneurysms Involving the Visceral Branch Vessels.
- Trial name
- TAMBE (NCT02528500)
- Testing
- GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- W.L.Gore & Associates
Peripheral Arterial Disease
Multi-center Study for Stent Graft System for Peripheral Artery
The utility of GP1101 will be evaluated relative to that of surgical bypass in the treatment of Femoral/Popliteal Arterial Symptomatic Peripheral Arterial Disease.
- Trial name
- VJH11-01 (NCT01575808)
- Testing
- GP1101
- Where
- 15 sites in Japan
- Volunteers
- 133 people
- Sponsor
- W.L.Gore & Associates
PAD
Clinical Investigation of the GORE® Drug-Coated PTA Balloon Catheter (GORE® DCB Catheter)
This study will assess the safety and performance of the Gore drug-coated balloon in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and popliteal arteries of patients with symptomatic…
- Trial name
- DCB (NCT02907203)
- Testing
- Drug Coated Balloon
- Where
- Germany
- Volunteers
- 52 people
- Sponsor
- W.L.Gore & Associates
Iatrogenic Vessel Injury
Treatment of Patients With Traumatic or Iatrogenic Vessel Injuries
The purpose of this study is to confirm device efficacy and safety of the GORE® VIABAHN® Endoprosthesis (hereafter "VB device") for the treatment of traumatic or iatrogenic vessel injury in thoracic, abdominal, and pelvic…
- Trial name
- NCT05183399
- Testing
- GORE® VIABAHN® Endoprosthesis
- Volunteers
- 30 people
- Sponsor
- W.L.Gore & Associates
Aneurysm of Aortic Arch
Early Feasibility of the Branched TAG® Device in the Treatment of Aortic Arch Aneurysms
The purpose of this study is to assess the early feasibility of the use of the GORE® TAG® Thoracic Branch Endoprosthesis to treat aneurysms involving the aortic arch
- Trial name
- NCT02264977
- Testing
- GORE® TAG® Thoracic Branch Endoprosthesis
- Where
- 6 sites in United States
- Volunteers
- 9 people
- Sponsor
- W.L.Gore & Associates
Aortic Aneurysm, Thoracic
Feasibility Study for GORE® TAG® Thoracic Branch Endoprosthesis to Treat Proximal Descending Thoracic Aortic Aneurysms
The purpose of this study is to assess the feasibility of the use of the GORE® TAG® Thoracic Branch Endoprosthesis to treat aneurysms involving the proximal Descending Thoracic Aorta (DTA)
- Trial name
- NCT02021812
- Testing
- GORE® TAG® Thoracic Branch Endoprosthesis
- Where
- 6 sites in United States
- Volunteers
- 31 people
- Sponsor
- W.L.Gore & Associates
Popliteal Artery Aneurysm
Evaluation of the GORE® VIABAHN® Endoprosthesis for the Treatment of Popliteal Artery Aneurysm (PAA)
This study will assess the long term safety and performance of the GORE® VIABAHN® Endoprosthesis for the treatment of patients with Popliteal Artery Aneurysms.
- Trial name
- NCT02462876
- Testing
- GORE® VIABAHN® Endoprosthesis
- Where
- France
- Volunteers
- 60 people
- Sponsor
- W.L.Gore & Associates
Common Iliac Artery Aneurysms, Aorto-iliac Aneurysms
Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis
The Iliac Branch Endoprosthesis (IBE) 12-04 study will be a prospective, nonrandomized, multicenter, single-arm evaluation designed to assess the safety and efficacy of the IBE Device in subjects with common iliac artery…
- Trial name
- NCT01883999
- Testing
- GORE® EXCLUDER® Iliac Branch Endoprosthesis
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- W.L.Gore & Associates
Biliary Strictures
Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures
The purpose of this study is to generate clinical data to support the use of GORE® VIABIL® Biliary Endoprosthesis in the endoscopic and percutaneous treatment of benign biliary strictures.
- Trial name
- NCT01343160
- Testing
- GORE® VIABIL® Biliary Endoprosthesis
- Where
- Germany
- Volunteers
- 43 people
- Sponsor
- W.L.Gore & Associates
Thoracic Diseases
Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL
Collect real-world clinical and device-specific outcomes of the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as part of routine…
- Trial name
- SURPASS (NCT03286400)
- Testing
- CTAG Device with ACTIVE CONTROL
- Where
- 20 sites in France, Germany and 5 more
- Volunteers
- 127 people
- Sponsor
- W.L.Gore & Associates
Stroke, Transient Ischemic Attack
GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients
The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk…
- Trial name
- REDUCE (NCT00738894)
- Testing
- Septal Occluder Device, Antiplatelet Medical Therapy
- Where
- 2 sites in United States, Denmark
- Volunteers
- 664 people
- Sponsor
- W.L.Gore & Associates