Clinical trials: sponsored by W.L.Gore & Associates
Aneurysm, Dissection, Aortic
Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis
The goal of this observational study is to collect mid-term post-market clinical follow-up data of GORE® TAG® Thoracic Branch Endoprosthesis used according to the standard medical practice in patients presenting with vascular…
- Conditions
- Aneurysm, Dissection, Aortic, TAA Thoracoabdominal Aortic Aneurysm, Thoracic Aortic Aneurysm
- Trial name
- NCT06507865
- Testing
- GORE® TAG® Thoracic Branch Endoprosthesis
- Where
- 19 sites in Austria, Denmark and 7 more
- Volunteers
- 155 people
- Sponsor
- W.L.Gore & Associates
Corneal Opacity
Clinical Outcomes of the Gore Synthetic Cornea Device
Study objective is to evaluate the initial safety and effectiveness of the GORE Synthetic Cornea Device in the treatment of loss of corneal clarity in patients who are candidates for corneal transplantation
- Trial name
- NCT06174376
- Testing
- GORE Synthetic Cornea Device
- Where
- 2 sites in Mexico
- Volunteers
- 10 people
- Sponsor
- W.L.Gore & Associates
Aneurysm of Aorta, Thoracic, Dissection of Aorta, Thoracic
TBE Zone 0/1 PMS in Japan
The goal of this surveillance is to confirm the safety and efficacy of TBE under actual use in the Zone 0/1 lesion on post-marketing usage conditions.
- Conditions
- Aneurysm of Aorta, Thoracic, Dissection of Aorta, Thoracic, Trauma
- Trial name
- NCT07691931
- Testing
- Gore® TAG® Thoracic Aortic Branch Stent Graft System
- Volunteers
- 75 people
- Sponsor
- W.L.Gore & Associates
Abdominal Aortic Aneurysm, Pararenal Aortic Aneurysm
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Approval Study
This study aims to confirm that the benefit-risk assessment of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) remains positive in real-world use and to ensure the adequacy of the TAMBE Device training…
- Conditions
- Abdominal Aortic Aneurysm, Pararenal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
- Trial name
- NCT06578741
- Testing
- GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)
- Where
- United States
- Volunteers
- 310 people
- Sponsor
- W.L.Gore & Associates
Aortoiliac Occlusive Disease
Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease
The study will assess the safety and effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis ("VBX Device" or also referred to as "VBX Stent Graft") in a post approval setting and evaluate the quality of the use…
- Trial name
- NCT06872905
- Testing
- GORE VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX)
- Where
- 26 sites in United States, Italy and 3 more
- Volunteers
- 158 people
- Sponsor
- W.L.Gore & Associates
Migraine, Patent Foramen Ovale
GORE® CARDIOFORM Septal Occluder Migraine Clinical Study
Multi-center, prospective, randomized, placebo- and sham-controlled study to evaluate the GORE® CARDIOFORM Septal Occluder for migraine headache relief
- Conditions
- Migraine, Patent Foramen Ovale, PFO - Patent Foramen Ovale
- Trial name
- RELIEF (NCT04100135)
- Testing
- Actual device PFO closure, Thienopyridine (clopidogrel or prasugrel)
- Where
- 15 sites in United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- W.L.Gore & Associates
Aorto-iliac Occlusive Disease (AIOD), Visceral Artery Occlusive Disease (VAOD)
GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry (RE-PROVE)
Collect real-world post-market clinical follow-up data on subjects treated with the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)
- Conditions
- Aorto-iliac Occlusive Disease (AIOD), Visceral Artery Occlusive Disease (VAOD), Isolated Artery Aneurysms (IAA), Trauma or Iatrogenic Vessel Injury
- Trial name
- NCT07279649
- Testing
- Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)
- Where
- Germany
- Volunteers
- 240 people
- Sponsor
- W.L.Gore & Associates
Aortic Aneurysm, Thoracic, Pseudoaneurysm
Evaluation of the GORE® Ascending Stent Graft
The primary objective of ARISE II is to assess the safety and effectiveness of the GORE® Ascending Stent Graft device in the treatment of lesions involving the ascending aorta and aortic arch.
- Conditions
- Aortic Aneurysm, Thoracic, Pseudoaneurysm, Aortic Dissection, Aorta; Lesion
- Trial name
- ARISEII (NCT05800743)
- Testing
- GORE® Ascending Stent Graft (ASG device), GORE® Thoracic Aortic Graft Thoracic Branch Endoprosthesis (TBE Device), Surgery
- Where
- 41 sites in United States
- Volunteers
- 370 people
- Sponsor
- W.L.Gore & Associates
Aortoiliac Occlusive Disease, Peripheral Arterial Disease
The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease
The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.
- Trial name
- NCT05811364
- Testing
- Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis, Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent
- Where
- 43 sites in United States, Australia and 5 more
- Volunteers
- 244 people
- Sponsor
- 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
Thoracoabdominal Aortic Aneurysm, Pararenal Aortic Aneurysm
TAMBE Japan Post-Marketing Surveillance
To evaluate the safety and efficacy of multi component system (TAMBE device) including GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (Aortic Component; AC) under post-marketing use.
- Trial name
- NCT07147569
- Testing
- GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
- Where
- 5 sites in Japan
- Volunteers
- 100 people
- Sponsor
- W.L.Gore & Associates
Peripheral Vascular Diseases
Post-Market Registry of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Implanted in Peripheral Vessels
The primary objective of the VBX 17-04 registry is to collect post-market safety and performance data of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX Stent Graft) in peripheral vessels in patients who require…
- Trial name
- EXPAND (NCT03720704)
- Testing
- GORE VIABAHN VBX Balloon Expandable Endoprosthesis
- Where
- 11 sites in France, Germany and 3 more
- Volunteers
- 280 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
Primary Open-angle Glaucoma
GORE Glaucoma Drainage Implant Clinical Study Dominican Republic
The objective of this early feasibility clinical study is to evaluate the safety and effectiveness of several different GORE Glaucoma Drainage Implant configurations in subjects with primary open-angle glaucoma that is…
- Trial name
- NCT05557058
- Testing
- Gore Glaucoma Device Implant (GORE GDI)
- Where
- Dominican Republic
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- W.L.Gore & Associates
Thoracoabdominal Aneurysm
Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)
Expanded access tothe GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is safe and effective in the treatment of thoracoabdominal and pararenal aneurysms.
- Trial name
- TAMBE (NCT05442489)
- Testing
- GORE Excluder Thoracoabdominal Branch Endoprosthesis
- Where
- 41 sites in United States
- Sponsor
- W.L.Gore & Associates
Multiple Pathologies
Global Registry for Endovascular Aortic Treatment (GREAT)
Prospective, observational Registry to obtain data on device performance and clinical outcomes.
- Trial name
- GREAT (NCT01658787)
- Testing
- Endovascular aortic repair
- Where
- 6 sites in United States, Australia and 2 more
- Volunteers
- 4,600 people
- Sponsor
- W.L.Gore & Associates
Heart Defects, Congenital, Tetralogy of Fallot
Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).
- Conditions
- Heart Defects, Congenital, Tetralogy of Fallot, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
- Trial name
- NCT03441971
- Testing
- GORE PV1
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- W.L.Gore & Associates
Aneurysm Thoracic, Dissection of Aorta, Thoracic
TBE Zone 2 PMS in Japan
The goal of this surveillance is to confirm the TBE device's safety and efficacy in patients treated with proximal landing in Zone 2 in the post-marketing period.
- Conditions
- Aneurysm Thoracic, Dissection of Aorta, Thoracic, Trauma
- Trial name
- NCT07049913
- Testing
- Gore® TAG® Thoracic Aortic Branch Stent Graft System
- Where
- Japan
- Volunteers
- 200 people
- Sponsor
- W.L.Gore & Associates
AAA - Abdominal Aortic Aneurysm
Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis
A prospective, observational post-market registry collecting outcomes through a 10-year post procedure follow-up for patients treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device) or the GORE® EXCLUDER®…
- Trial name
- NCT06218875
- Where
- 90 sites in United States, Australia and 10 more
- Volunteers
- 2,000 people
- Sponsor
- W.L.Gore & Associates
Hernia, Ventral, Hernia Incisional
Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application
The SYN 20-01 Study is a non-interventional, prospective, multicenter, multicohort, international, post-market clinical investigation looking into the assessment of GORE® SYNECOR Biomaterial in focused patient populations and in…
- Conditions
- Hernia, Ventral, Hernia Incisional, Hernia Incisional Ventral
- Trial name
- SYN 20-01 (NCT05094089)
- Testing
- Hernia repair with mesh
- Where
- 15 sites in United States, Italy and 2 more
- Volunteers
- 320 people
- Sponsor
- W.L.Gore & Associates