Clinical trials: completed, sponsored by W.L.Gore & Associates
Carotid Artery Disease, Carotid Artery Stenosis
The Gore SCAFFOLD Clinical Study
Evaluate the safety and efficacy of the GORE® Carotid Stent for the treatment of carotid artery stenosis in patients at increased risk for adverse events from carotid endarterectomy
- Trial name
- NCT01901874
- Testing
- Carotid Artery Stenting
- Where
- 2 sites in United States
- Volunteers
- 312 people
- Sponsor
- W.L.Gore & Associates
Septal Defect, Atrial
Safety and Efficacy of the GORE® Septal Occluder to Treat Ostium Secundum Atrial Septal Defects
The primary objective of the GORE® Septal Occluder Study is to evaluate the safety and efficacy of the occluder device in the treatment of transcatheter closure of ostium secundum atrial septal defects (ASDs).
- Trial name
- NCT01711983
- Testing
- GORE® CARDIOFORM Septal Occluder
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- W.L.Gore & Associates
Abdominal Aortic Aneurysm
GORE® EXCLUDER® 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® Excluder® Endoprosthesis in the treatment of infra-renal Abdominal Aortic Aneurysms (AAA).
- Trial name
- NCT02308839
- Testing
- GORE® EXCLUDER® Endoprosthesis
- Where
- France
- Volunteers
- 181 people
- Sponsor
- W.L.Gore & Associates
Common Iliac Artery Occlusive Disease, External Iliac Artery Occlusive Disease
Evaluation of the GORE® VIABAHN® BALLOON EXPANDABLE ENDOPROSTHESIS (VIABAHN BX)
The primary objective of the VBX13-05 clinical study is to evaluate the safety and efficacy of VIABAHN BX for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or…
- Conditions
- Common Iliac Artery Occlusive Disease, External Iliac Artery Occlusive Disease, Peripheral Arterial Disease
- Trial name
- NCT01961167
- Testing
- Stenting of common and/or external iliacs
- Where
- New Zealand
- Volunteers
- 27 people
- Sponsor
- W.L.Gore & Associates
Peripheral Arterial Disease
A Study of the Gore VIABAHN BX for Treatment of Occlusive Disease in the Iliac Arteries.
Evaluation of the Gore(R) VIABAHN BX for the treatment of arterial occlusive disease in the common and/or external iliac arteries.
- Trial name
- VBXFLEX (NCT02080871)
- Testing
- Stenting of the Common and/or External Iliac Arteries
- Where
- 27 sites in United States, New Zealand
- Volunteers
- 134 people
- Sponsor
- W.L.Gore & Associates
Septal Defect, Atrial
Long-term Safety Study of the GORE® HELEX® Septal Occluder
The purpose of this study is to evaluate the long-term safety and efficacy of the GORE® HELEX® Septal Occluder in the treatment of ostium secundum atrial septal defects (ASDs).
- Trial name
- NCT00581308
- Testing
- GORE® HELEX® Septal Occluder
- Where
- United States
- Volunteers
- 215 people, healthy volunteers welcome
- Sponsor
- W.L.Gore & Associates
Aortic Aneurysm, Abdominal
GORE EXCLUDER® Endoprosthesis - Low Permeability in Treatment of Abdominal Aortic Aneurysms
The purpose of this study is to evaluate the performance of the GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability in the primary treatment of infrarenal abdominal aortic aneurysms.
- Trial name
- NCT00593814
- Testing
- GORE EXCLUDER® Bifurcated Endoprosthesis-Low Permeability
- Volunteers
- 139 people
- Sponsor
- W.L.Gore & Associates
Type B Aortic Dissection
Evaluation of the GORE Conformable TAG® Thoracic Endoprosthesis for Treatment of Acute Complicated Type B Aortic Dissection
The primary objective of this study is to determine the safety and efficacy of the GORE Conformable TAG Thoracic Endoprosthesis (CTAG) for treatment of subjects with acute complicated type B aortic dissection.
- Trial name
- NCT00908388
- Testing
- GORE TAG® Thoracic Endoprosthesis
- Where
- 37 sites in United States
- Volunteers
- 50 people
- Sponsor
- W.L.Gore & Associates
Peripheral Arterial Disease
Evaluation of the GORE TIGRIS Vascular Stent
The primary objective of the randomized study is to evaluate the safety and effectiveness of the TIGRIS Vascular Stent in the treatment of de novo and restenotic atherosclerotic lesions, ≤ 24cm in length, in the superficial…
- Trial name
- TIGRIS (NCT01576055)
- Testing
- TIGRIS Vascular Stent, BARD LifeStent
- Where
- 34 sites in United States
- Volunteers
- 267 people
- Sponsor
- W.L.Gore & Associates
Thoracic Injuries
Evaluation of the GORE Conformable TAG® for Treatment of Traumatic Transection
TAG 08-02 is a prospective, multicenter, single-arm study to evaluate the use of the CTAG Device in traumatic transection of the descending thoracic aorta.
- Trial name
- NCT00917852
- Testing
- Gore Conformable TAG Thoracic Endoprosthesis
- Where
- 26 sites in United States
- Volunteers
- 51 people
- Sponsor
- W.L.Gore & Associates
Aneurysm
Thoracic Endoprosthesis for Treatment of Aneurysm of the Descending Thoracic Aortic
To assess the safety and efficacy of the GORE Conformable TAG® Thoracic Endoprosthesis in the primary treatment of aneurysm of the descending thoracic aorta (DTA) > Primary Hypothesis: The proportion of subjects free from a major…
- Trial name
- NCT00874250
- Testing
- GORE CTAG Device
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- W.L.Gore & Associates
Carotid Artery Stenosis
GORE® Embolic Filter in Carotid Stenting for High Risk Surgical Subjects (EMBOLDEN)
Compare the 30-day safety and efficacy of the GORE® Embolic Filter used in conjunction with FDA-approved carotid stents to a performance goal obtained from carotid stent studies utilizing distal embolic protection.
- Trial name
- EMBOLDEN (NCT00766493)
- Testing
- GORE® Embolic Filter
- Volunteers
- 250 people
- Sponsor
- W.L.Gore & Associates
Carotid Stenosis, Constriction, Pathologic
GORE Flow Reversal System and GORE Embolic Filter Extension Study
The objective of this study is to provide an ongoing evaluation of clinical outcomes associated with the GORE Flow Reversal System and the GORE Embolic Filter when used for embolic protection during carotid artery stenting.
- Conditions
- Carotid Stenosis, Constriction, Pathologic, Carotid Artery Diseases, Cerebrovascular Disorders
- Trial name
- FREEDOM (NCT01343667)
- Testing
- Gore Flow Reversal System, Gore Embolic Filter
- Where
- 39 sites in United States
- Volunteers
- 1,397 people
- Sponsor
- 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
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
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