Clinical trials: sponsored by W.L.Gore & Associates
Ventral Incisional Hernia
Open Complex Ventral Incisional Hernia Repair Using Biosynthetic Material for Midline Fascial Closure Reinforcement
Prospective, multicenter, observational study to evaluate performance of GORE® BIO-A® Tissue Reinforcement when used to reinforce midline fascial closure in single-staged open complex ventral incisional hernia repair.
- Trial name
- COBRA (NCT01325792)
- Testing
- GORE® BIO-A® Tissue Reinforcement
- Where
- 9 sites in United States, Netherlands
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- W.L.Gore & Associates
Peripheral Vascular Diseases
Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis
The purpose of this study is to confirm the safety and performance of the 25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used in the Superficial Femoral Artery.
- Trial name
- NCT01263665
- Testing
- 25 cm GORE® VIABAHN®
- Volunteers
- 71 people
- Sponsor
- W.L.Gore & Associates
Popliteal Artery Aneurysm
Evaluation of GORE® VIABAHN® Endoprosthesis for Popliteal Artery Aneurysm
This is a multicenter, non-randomized, single arm, retrospective study of GORE® VIABAHN® Endoprosthesis for the treatment of a Popliteal Artery Aneurysm (PAA).
- Trial name
- PAA 12-01 (NCT01902888)
- Testing
- GORE® VIABAHN® Endoprosthesis
- Where
- 3 sites in United States
- Volunteers
- 3 people
- Sponsor
- W.L.Gore & Associates
Aortic Aneurysm, Abdominal
Study of the Large Diameter GORE EXCLUDER® AAA Endoprosthesis in Abdominal Aneurysms
The purpose of this study is to assess the safety and efficacy of the 31 mm GORE EXCLUDER® AAA Endoprosthesis in the treatment of infrarenal abdominal aortic aneurysms
- Trial name
- NCT00615069
- Testing
- 31 mm GORE EXCLUDER® AAA Endoprosthesis
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- W.L.Gore & Associates
Aortic Aneurysm, Thoracic
GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta
The objective of this study is to assess the safety and efficacy of the 45 mm TAG device in subjects with aneurysms of the descending thoracic aorta.
- Trial name
- NCT00608829
- Testing
- GORE TAG® Thoracic Endoprosthesis
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- W.L.Gore & Associates
Renal Failure, Hemodialysis
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
The objective of the study is to establish efficacy and safety of the GORE VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used to revise arteriovenous (AV) prosthetic grafts at the venous anastomosis in the…
- Trial name
- REVISE (NCT00737672)
- Testing
- GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface, Percutaneous Transluminal Angioplasty
- Where
- 31 sites in United States
- Volunteers
- 293 people
- Sponsor
- W.L.Gore & Associates
Aortic Aneurysm, Thoracic
Evaluation of the GORE TAG Thoracic Endoprosthesis in the Treatment of Aneurysms
The purpose of this post-approval study is to evaluate the long-term performance of the GORE TAG® Thoracic Endoprosthesis (TAG device) in the primary treatment of descending thoracic aortic (DTA) aneurysms
- Trial name
- NCT00590759
- Testing
- GORE TAG® Thoracic Endoprosthesis
- Where
- 25 sites in United States
- Volunteers
- 150 people
- Sponsor
- W.L.Gore & Associates
Liver Cirrhosis, Portal Hypertension
Early TIPS for Ascites Study
The purpose of this study is to demonstrate that TIPS with the GORE® VIATORR® TIPS Endoprosthesis improves transplant-free survival compared to LVP alone in patients who have cirrhosis of the liver with portal hypertension and…
- Conditions
- Liver Cirrhosis, Portal Hypertension, Ascites
- Trial name
- NCT01236339
- Testing
- TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis, LVP, TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol
- Where
- 2 sites in United States
- Volunteers
- 26 people
- Sponsor
- W.L.Gore & Associates
Closure; Foramen Ovale
GORE® Septal Occluder European Union Clinical Evaluation
The primary objective of this study is to evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of Patent Foramen Ovale (PFO).
- Trial name
- NCT01605851
- Testing
- Closure, Foramen Ovale
- Where
- 9 sites in Denmark, Germany and 3 more
- Volunteers
- 150 people
- Sponsor
- W.L.Gore & Associates
Carotid Artery Stenosis
GORE Embolic Protection With Reverse Flow
To compare the 30-day safety and efficacy of the GORE Flow Reversal System when used with approved carotid stents to an Objective Performance Criterion derived from distal embolic protection studies.
- Trial name
- EMPiRE (NCT00594100)
- Testing
- GORE Flow Reversal System (GFRS)
- Where
- 2 sites in United States
- Volunteers
- 245 people
- Sponsor
- W.L.Gore & Associates
Aortic Diseases
A European Study on Medical Management Versus TAG Device + Medical Management for Acute Uncomplicated Type B Dissection
The purpose of this study is to compare endoluminal stent grafting with the GORE TAG device and Best Medical Therapy (BMT) to BMT alone in the treatment of acute uncomplicated type B aortic dissections.
- Trial name
- ADSORB (NCT00742274)
- Testing
- Gore TAG Endoprosthesis, Best Medical Therapy
- Volunteers
- 61 people
- Sponsor
- W.L.Gore & Associates
End Stage Renal Disease
Evaluation of the GORE® ACUSEAL Vascular Graft for Hemodialysis Access
This study is a prospective, non-randomized, multi-center evaluation of the performance of the GORE® ACUSEAL Vascular Graft. The study will enroll patients with End-Stage Renal Disease (ESRD), who are either currently receiving…
- Trial name
- ACUSEAL (NCT01173718)
- Testing
- GORE® ACUSEAL Vascular Graft
- Volunteers
- 138 people
- Sponsor
- W.L.Gore & Associates
Peripheral Vascular Diseases
GORE VIABAHN Endoprosthesis With Heparin Bioactive Surface in the Treatment of SFA Obstructive Disease (VIPER)
The objective of the study is collect data on the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface in the treatment of chronic Superficial Femoral Artery disease. Device patency at 12 months is the primary endpoint.
- Trial name
- VIPER (NCT00541307)
- Testing
- Treatment with the GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface
- Where
- 5 sites in United States
- Volunteers
- 119 people
- Sponsor
- W.L.Gore & Associates
Peripheral Vascular Diseases
GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study
To evaluate the performance of the GORE VIABAHN® Endoprosthesis compared to a bare nitinol stent for the treatment of superficial femoral artery (SFA) occlusive disease in long lesions.
- Trial name
- NCT00228384
- Testing
- GORE VIABAHN Endoprosthesis, Bare Nitinol Stent
- Where
- 15 sites in United States
- Volunteers
- 148 people
- Sponsor
- W.L.Gore & Associates
Peripheral Arterial Occlusive Disease
GORE PROPATEN Vascular Graft vs. Disadvantaged Autologous Vein Graft
The primary patency of the GORE PROPATEN Vascular Graft is equivalent to or better than disadvantaged autologous vein graft in an infragenicular peripheral bypass application at 12 months.
- Trial name
- PRODIGY (NCT00617279)
- Testing
- GORE PROPATEN Vascular Graft, Disadvantaged Autologous Vein Graft
- Where
- 17 sites in United States
- Volunteers
- 31 people
- Sponsor
- W.L.Gore & Associates
Peripheral Vascular Diseases
GORE-TEX PROPATEN Vascular Graft Study
To demonstrate equivalence in patency performance of GORE-TEX PROPATEN Vascular Grafts and Thin Walled GORE-TEX Stretch Vascular Grafts in a peripheral bypass application to support a claim of substantial equivalence.
- Trial name
- NCT00205790
- Testing
- Vascular graft
- Where
- 18 sites in United States
- Volunteers
- 200 people
- Sponsor
- W.L.Gore & Associates