Clinical trials: sponsored by W.L.Gore & Associates
Common Iliac Artery Aneurysms, Aorto-iliac Aneurysms
Evaluation of the GORE® EXCLUDER® Iliac Branch Endoprosthesis
The Iliac Branch Endoprosthesis (IBE) 12-04 study will be a prospective, nonrandomized, multicenter, single-arm evaluation designed to assess the safety and efficacy of the IBE Device in subjects with common iliac artery…
- Trial name
- NCT01883999
- Testing
- GORE® EXCLUDER® Iliac Branch Endoprosthesis
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- W.L.Gore & Associates
Biliary Strictures
Removable GORE VIABIL® Biliary Endoprosthesis for Treatment of Benign Biliary Strictures
The purpose of this study is to generate clinical data to support the use of GORE® VIABIL® Biliary Endoprosthesis in the endoscopic and percutaneous treatment of benign biliary strictures.
- Trial name
- NCT01343160
- Testing
- GORE® VIABIL® Biliary Endoprosthesis
- Where
- Germany
- Volunteers
- 43 people
- Sponsor
- W.L.Gore & Associates
Thoracic Diseases
Observational Registry Characterizing the CTAG Device With ACTIVE CONTROL
Collect real-world clinical and device-specific outcomes of the GORE® TAG® Conformable Thoracic Stent Graft featuring ACTIVE CONTROL System (CTAG Device with ACTIVE CONTROL) in the treatment of aortic disease as part of routine…
- Trial name
- SURPASS (NCT03286400)
- Testing
- CTAG Device with ACTIVE CONTROL
- Where
- 20 sites in France, Germany and 5 more
- Volunteers
- 127 people
- Sponsor
- W.L.Gore & Associates
Stroke, Transient Ischemic Attack
GORE® Septal Occluder Device for Patent Foramen Ovale (PFO) Closure in Stroke Patients
The primary objective is to determine if patent foramen ovale (PFO) closure with the GORE® HELEX® Septal Occluder or GORE® CARDIOFORM Septal Occluder plus antiplatelet medical management is safe and effective and reduces the risk…
- Trial name
- REDUCE (NCT00738894)
- Testing
- Septal Occluder Device, Antiplatelet Medical Therapy
- Where
- 2 sites in United States, Denmark
- Volunteers
- 664 people
- Sponsor
- 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
Rectal Cancer, Ulcerative Colitis
Bioabsorbable Staple Line Reinforcement in Colorectal,Coloanal and Ileoanal Anastomoses
The primary purpose of this prospective, randomized multicenter center study is to evaluate and compare the outcomes of colorectal, coloanal and ileoanal anastomoses reinforced with a bioabsorbable staple line reinforcement…
- Conditions
- Rectal Cancer, Ulcerative Colitis, Familial Adenomatous Polyposis, Diverticulitis
- Trial name
- NCT00663819
- Testing
- GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement, Staple line without reinforcement
- Where
- 16 sites in United States
- Volunteers
- 258 people
- Sponsor
- W.L.Gore & Associates
End Stage Renal Disease
Evaluation of Anti-platelet Factor 4/Heparin Antibodies in Hemodialysis Patients
To characterize the GORE® Hybrid Vascular Graft as compared to non-heparin bonded synthetic vascular grafts in terms of the prevalence and persistence of anti-platelet factor 4 / heparin antibodies (anti-PF4 / H antibodies).
- Trial name
- NCT02165761
- Testing
- GORE® Hybrid Vascular Graft, Non-heparin bonded synthetic graft
- Where
- 4 sites in United States
- Volunteers
- 42 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
Anal Fistula
Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair
Primary outcome variable is healing at the final follow up visit.
- Trial name
- NCT01290666
- Testing
- Fistula Plug
- Volunteers
- 93 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