Clinical trials: sponsored by 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
Aortic Dissection
GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
To assess the safety and effectiveness of the ASG device in the treatment of de novo Type A aortic dissections.
- Trial name
- ARISE III (NCT06827990)
- Testing
- GORE® Ascending Stent Graft (ASG device)
- Where
- 22 sites in United States
- Volunteers
- 112 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
- 22 sites in United States
- Volunteers
- 125 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
Chronic Liver Disease
VIATORR Device Registry
The primary objective is to confirm the clinical performance and safety of the GORE® VIATORR® TIPS (Transjugular Intrahepatic Portosystemic Shunt) Endoprosthesis with Controlled Expansion throughout the device functional lifetime…
- Trial name
- NCT05661331
- Testing
- Transjugular intrahepatic portosystemic shunt
- Where
- 7 sites in Austria, France and 3 more
- Volunteers
- 196 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
Abdominal Aortic Aneurysm, Thoracic Aortic Aneurysm
Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used as a Bridging Stent With Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries
Multicenter, single-arm retrospective and prospective registry is being conducted to confirm the clinical performance and safety of GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched…
- Trial name
- EMBRACE (NCT05143138)
- Testing
- GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
- Where
- 14 sites in Denmark, Italy and 4 more
- Volunteers
- 259 people
- Sponsor
- W.L.Gore & Associates
Aortic Aneurysm, Thoracic, Aorta; Lesion
Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2
The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta, requiring Zone 2 proximal implantation…
- Trial name
- SSB 11-02 (NCT02777593)
- Testing
- GORE® TAG® Thoracic Branch Endoprosthesis
- Where
- 35 sites in United States
- Volunteers
- 250 people
- Sponsor
- W.L.Gore & Associates
Aortic Aneurysm, Thoracic, Aorta, Lesion
Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 0/1
The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.
- Trial name
- SSB 11-02 (NCT02777528)
- Testing
- GORE® TAG® Thoracic Branch Endoprosthesis, Revascularization Procedure
- Where
- 39 sites in United States, Japan
- Volunteers
- 79 people
- Sponsor
- W.L.Gore & Associates
Thoracoabdominal Aortic Aneurysm
Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
Prospective, non-randomized, , multicenter study with two independent arms: Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis.
- Trial name
- TAMBE (NCT03728985)
- Testing
- GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
- Where
- 44 sites in United States, United Kingdom
- Volunteers
- 102 people
- Sponsor
- W.L.Gore & Associates
Venous Thromboses, Venous Disease
The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study
This study is a prospective, multicenter, non-randomized, single-arm study to evaluate the performance, safety, and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) for…
- Conditions
- Venous Thromboses, Venous Disease, Venous Leg Ulcer, Venous Stasis
- Trial name
- NCT05409976
- Testing
- GORE® VIAFORT Vascular Stent
- Where
- 17 sites in United States, Australia and 5 more
- Volunteers
- 136 people
- Sponsor
- W.L.Gore & Associates
Peripheral Artery Disease, Popliteal Aneurysm
Observational GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Global Registry
Collect real-world post-market clinical follow-up data on patients treated with the GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
- Conditions
- Peripheral Artery Disease, Popliteal Aneurysm, Hemodialysis Access, Visceral Artery Aneurysms
- Trial name
- NCT04907240
- Testing
- GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface (VSX)
- Where
- 26 sites in Belgium, France and 7 more
- Volunteers
- 614 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
Venous Thromboses, Venous Disease
The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study
This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent)…
- Conditions
- Venous Thromboses, Venous Disease, Venous Leg Ulcer, Venous Stasis
- Trial name
- NCT05489588
- Testing
- GORE® VIAFORT Vascular Stent
- Where
- 24 sites in United States
- Volunteers
- 165 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
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
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