Clinical trials: open to volunteers, sponsored by 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
- 27 sites in United States, Italy and 3 more
- Volunteers
- 158 people
- Sponsor
- W.L.Gore & Associates
Aortic Arch Dissection, Aortic Arch Aneurysm
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
A prospective multi-center post-market study collecting outcomes through at least 5-years and up to 10-years post procedure for subjects treated with the TBE Device in Zone 0/1 as part of routine clinical practice.
- Trial name
- NCT07166133
- Testing
- GORE® TAG® Thoracic Branch Endoprosthesis
- Where
- 24 sites in United States
- Volunteers
- 125 people
- Sponsor
- W.L.Gore & Associates
Hernia, Ventral, Hernia, Hiatal
GORE® ENFORM Biomaterial Product Study
A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral / Incisional Hernia Repair and Diaphragmatic / Hiatal Hernia Repair).
- Conditions
- Hernia, Ventral, Hernia, Hiatal, Hernia, Diaphragmatic, Incisional Hernia
- Trial name
- ENF 18-06 (NCT04718168)
- Testing
- Gore ENFORM Biomaterial (Preperitoneal), Gore ENFORM Biomaterial (Intraperitoneal)
- Where
- 9 sites in United States
- Volunteers
- 245 people
- Sponsor
- W.L.Gore & Associates
Venous Thromboses, Venous Disease
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.
- Conditions
- Venous Thromboses, Venous Disease, Venous Leg Ulcer, Venous Stasis
- Trial name
- NCT07538609
- Testing
- GORE® VIABAHN® FORTEGRA Venous Stent
- Where
- 4 sites in United States
- Volunteers
- 150 people
- Sponsor
- W.L.Gore & Associates
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
The registry population consists of patients presenting with complex aortic pathologies amenable to endovascular aortic repair that requires the incorporation of bridging stents to maintain visceral artery perfusion
- Conditions
- Complex Aortic Aneurysms, Thoracoabdominal Aneurysm, Fenestrated Endovascular Aortic Repair, Endovascular Aortic Repair
- Trial name
- ENVISION (NCT07480395)
- Where
- 26 sites in Austria, Denmark and 8 more
- Volunteers
- 400 people
- Sponsor
- W.L.Gore & Associates
End Stage Renal Disease (ESRD), Kidney Failure
A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease
The goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD).
- Conditions
- End Stage Renal Disease (ESRD), Kidney Failure, Chronic Renal Disease, Hemodialysis
- Trial name
- NCT04671771
- Testing
- InnAVasc Arteriovenous Graft (IG) surgical implant
- Where
- 22 sites in United States
- Volunteers
- 133 people
- Sponsor
- W.L.Gore & Associates
Ascites, Variceal Bleeding
VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)
This Registry will look at patients being treated with a transjugular intrahepatic portosystemic shunt (TIPS) procedure for portal hypertension.
- Conditions
- Ascites, Variceal Bleeding, Portal Hypertension Related to Cirrhosis
- Trial name
- VIATIPS (NCT07390344)
- Testing
- GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm)
- Where
- 3 sites in United States
- Volunteers
- 152 people
- Sponsor
- W.L.Gore & Associates
Thoracic Aortic Aneurysm, Penetrating Aortic Ulcers (PAUs)
MBA Early Feasibility Study
The MBA 25-04 study is a prospective, multicenter, non-randomized, single-arm, early feasibility study designed to assess the initial safety of the MBA device through five years following the index endovascular procedure.
- Conditions
- Thoracic Aortic Aneurysm, Penetrating Aortic Ulcers (PAUs), Thoracic Aortic Dissection, Pseudoaneurysm
- Trial name
- NCT07564375
- Testing
- GORE® Multibranch Arch Endoprosthesis, GORE® Ascending Stent Graft
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- W.L.Gore & Associates
Vascular Disease, Dissection
Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance
An observational, prospective multi-regional post-market registry collecting mid- and long-term data to assess outcomes through ten years of follow-up for subjects treated with GORE® TAG® Conformable Thoracic Stent Graft with…
- Conditions
- Vascular Disease, Dissection, Dissection Aortic Aneurysm, Dissection of Aorta
- Trial name
- TGR 23-02TA (NCT06658730)
- Testing
- Endovascular
- Where
- 37 sites in United States, Denmark and 8 more
- Volunteers
- 1,500 people
- Sponsor
- W.L.Gore & Associates
Chronic Kidney Diseases, End Stage Renal Disease on Dialysis
Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access
The goal of this observational study is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis.
- Trial name
- AVG22-09 (NCT05846581)
- Testing
- GORE® ACUSEAL Vascular Graft
- Where
- 4 sites in Germany, Italy and 1 more
- Volunteers
- 72 people
- Sponsor
- W.L.Gore & Associates
Dissection of Aorta, Aneurysm Aortic
Retrospective Real-World Data Collection of the Conformable GORE® TAG® Thoracic Endoprosthesis When Used in Frozen Elephant Trunk Procedures for Treatment of Aortic Aneurysms and Dissections
Retrospective, multicenter, single-arm registry data collection designed to characterize outcomes in patients treated with the Conformable GORE® TAG® Thoracic Endoprosthesis deployed in an antegrade fashion as part of a frozen…
- Conditions
- Dissection of Aorta, Aneurysm Aortic, Frozen Elephant Trunk
- Trial name
- NCT07742592
- Testing
- Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure
- Volunteers
- 350 people
- Sponsor
- W.L.Gore & Associates
Stroke, PFO - Patent Foramen Ovale
GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study
This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a…
- Trial name
- REDUCE PAS (NCT03821129)
- Testing
- PFO closure with GORE® CARDIOFORM Septal Occluder
- Where
- 45 sites in United States
- Volunteers
- 636 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
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
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
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
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
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