Clinical trials: sponsored by W.L.Gore & Associates
Common Iliac Artery Aneurysm, Aorto Iliac Aneurysm
Assessment of GORE® EXCLUDER® IBE Plus Stent Graft Performance in Patients Undergoing Endovascular Iliac Revascularization
The IBE 25-05 study will be a prospective, non-randomized, multicenter, interventional two arm evaluation designed to assess the safety and effectiveness of the GORE® EXCLUDER® IBE Plus Stent Graft in patients with common iliac…
- Trial name
- NCT07304102
- Testing
- GORE® EXCLUDER® IBE Plus Stent Graft
- Volunteers
- 100 people
- Sponsor
- W.L.Gore & Associates
Stroke, PFO - Patent Foramen Ovale
Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder
The purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan.
- Conditions
- Stroke, PFO - Patent Foramen Ovale, Cryptogenic Stroke, TIA
- Trial name
- GSO-PFO PMS (NCT05529901)
- Testing
- GORE® CARDIOFORM Septal Occluder
- Where
- Japan
- Volunteers
- 300 people
- Sponsor
- W.L.Gore & Associates
Breast Reconstruction Surgery
Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures.
- Trial name
- NCT06556654
- Testing
- TRBR Device
- Where
- 20 sites in United States
- Volunteers
- 180 people
- Sponsor
- W.L.Gore & Associates
Aortic Aneurysm, Abdominal
Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta.
- Trial name
- NCT02489539
- Testing
- GORE® EXCLUDER® Conformable AAA Endoprosthesis
- Where
- 51 sites in United States
- Volunteers
- 175 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
Kidney Failure, Chronic, Renal Dialysis
Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With Kidney Failure
The CSP-1001 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis in participants suffering from end stage renal failure (ESRD).
- Trial name
- NCT03645681
- Testing
- InnAVasc arteriovenous graft surgical implant
- Where
- 7 sites in United States
- Volunteers
- 26 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
Pancreatitis, Chronic, Stricture; Bile Duct
GORE® VIABIL® Biliary Endoprosthesis in the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis
This study will evaluate the safety and effectiveness of the GORE® VIABIL® Biliary Endoprosthesis in the treatment of benign biliary strictures secondary to Chronic Pancreatitis (CP).
- Trial name
- VIABILITY (NCT05820009)
- Testing
- GORE® VIABIL® Biliary Endoprosthesis, GORE® VIABIL® Short Wire Biliary Endoprosthesis
- Where
- 2 sites in United States
- Volunteers
- 133 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