Clinical trials: sponsored by W.L.Gore & Associates
Thoracoabdominal Aneurysm
Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)
Expanded access tothe GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is safe and effective in the treatment of thoracoabdominal and pararenal aneurysms.
- Trial name
- TAMBE (NCT05442489)
- Testing
- GORE Excluder Thoracoabdominal Branch Endoprosthesis
- Where
- 41 sites in United States
- Sponsor
- W.L.Gore & Associates
Cirrhosis, Liver, Transjugular Intrahepatic Portosystemic Shunt (TIPS)
ALTA TIPS: A 5-year Longitudinal Observational Study of Patients Undergoing TIPS Placement
ALTA is a multicenter consortium focused on the management of portal hypertension. ALTA TIPS is a longitudinal observational study of patients who are undergoing transjugular intrahepatic portosystemic shunt (TIPS) placement.
- Trial name
- NCT03973372
- Where
- 14 sites in United States
- Volunteers
- 852 people
- Sponsor
- University of Texas Southwestern Medical Center
Multiple Pathologies
Global Registry for Endovascular Aortic Treatment (GREAT)
Prospective, observational Registry to obtain data on device performance and clinical outcomes.
- Trial name
- GREAT (NCT01658787)
- Testing
- Endovascular aortic repair
- Where
- 6 sites in United States, Australia and 2 more
- Volunteers
- 4,600 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
Heart Defects, Congenital, Tetralogy of Fallot
Evaluation of the GORE PV1 Device in Patients With Pulmonary Valve Dysfunction
This study will assess the safety and performance of the GORE PV1 Device for replacement of the pulmonary valve and reconstruction of the Right Ventricular Outflow Tract (RVOT).
- Conditions
- Heart Defects, Congenital, Tetralogy of Fallot, Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
- Trial name
- NCT03441971
- Testing
- GORE PV1
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- W.L.Gore & Associates
Abdominal Aortic Aneurysms, Common Iliac Aneurysms
Iliac Branch Excluder ReGistry (IceBERG)
This post market registry consists of a retrospective and a prospective part. The first part is a retrospective registry of all implanted IBE devices of Gore in the Netherlands after CE mark was obtained, to get an initial…
- Conditions
- Abdominal Aortic Aneurysms, Common Iliac Aneurysms, Aneurysm
- Trial name
- IceBERG (NCT02345005)
- Testing
- The Gore® EXCLUDER® ILIAC BRANCH Endoprosthesis.
- Where
- 8 sites in Italy, Netherlands and 2 more
- Volunteers
- 100 people
- Sponsor
- Rijnstate Hospital
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
Stroke, PFO - Patent Foramen Ovale
Japan Post Marketing Surveillance of the GORE® CARDIOFORM Septal Occluder
The purpose of this post-marketing surveillance is to evaluate the effectiveness and safety of GORE® CARDIOFORM Septal Occluder under the post-marketing setting in Japan.
- Conditions
- Stroke, PFO - Patent Foramen Ovale, Cryptogenic Stroke, TIA
- Trial name
- GSO-PFO PMS (NCT05529901)
- Testing
- GORE® CARDIOFORM Septal Occluder
- Where
- Japan
- Volunteers
- 300 people
- Sponsor
- W.L.Gore & Associates
Breast Reconstruction Surgery
Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures.
- Trial name
- NCT06556654
- Testing
- TRBR Device
- Where
- 20 sites in United States
- Volunteers
- 180 people
- Sponsor
- W.L.Gore & Associates
Aortic Aneurysm, Abdominal
Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta.
- Trial name
- NCT02489539
- Testing
- GORE® EXCLUDER® Conformable AAA Endoprosthesis
- Where
- 51 sites in United States
- Volunteers
- 175 people
- Sponsor
- W.L.Gore & Associates
Patent Foramen Ovale, Cryptogenic Stroke
Comparison of Lower vs Upper Extremity Injection Agitated Saline to Identify Patent Foramen Ovale With Echocardiography
Study Title LOwer vs upper extremity injection agitated saline for identifiCation of pATent foramen ovalE (LOCATE) Pilot study to determine safety of lower extremity injection of agitated saline for echocardiography of the heart.
- Conditions
- Patent Foramen Ovale, Cryptogenic Stroke, Embolic Infarction
- Trial name
- LOCATE (NCT07009678)
- Testing
- intravenous access in greater saphenous vein compared to upper extremity site.
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- St. John's Hospital
PAD - Peripheral Arterial Disease, AAA - Abdominal Aortic Aneurysm
Retrospective Post-Market Clinical Follow-Up Study of GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft in Peripheral Artery Disease, Aortic Aneurysms, and Dialysis Access
This multicenter, single-arm retrospective registry (chart review) is being conducted to confirm the clinical performance and safety of GORE-TEX® Vascular Grafts and GORE® PROPATEN® Vascular Graft throughout the device functional…
- Conditions
- PAD - Peripheral Arterial Disease, AAA - Abdominal Aortic Aneurysm, End-Stage Renal Disease
- Trial name
- NCT05124184
- Testing
- GORE® PROPATEN® Vascular Graft, GORE-TEX® Vascular Grafts
- Where
- 8 sites in France, Italy and 1 more
- Volunteers
- 356 people
- Sponsor
- W.L.Gore & Associates
Kidney Failure, Chronic, Renal Dialysis
Evaluating the Safety and Effectiveness of the InnAVasc Graft for Dialysis Access in Patients With Kidney Failure
The CSP-1001 study will evaluate the safety and effectiveness of the InnAVasc arteriovenous graft (AVG) when implanted in and used for hemodialysis in participants suffering from end stage renal failure (ESRD).
- Trial name
- NCT03645681
- Testing
- InnAVasc arteriovenous graft surgical implant
- Where
- 7 sites in United States
- Volunteers
- 26 people
- Sponsor
- W.L.Gore & Associates
Vascular Stent-Graft Stenosis
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study
This study will confirm the efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® stent graft (hereafter referred to as "Viabahn") for the treatment of patients with stenosis or occlusion at the…
- Trial name
- NCT04429243
- Testing
- GORE® VIABAHN® Stent Graft
- Where
- 17 sites in Japan
- Volunteers
- 124 people
- Sponsor
- W.L.Gore & Associates
Thoracic Aortic Aneurysm, Thoracic Aorta Injury
CTAG Dissection/Trauma Post Marketing Surveillance Japan
Post Marketing Surveillance of the Conformable GORE® TAG® Thoracic Endoprosthesis
- Conditions
- Thoracic Aortic Aneurysm, Thoracic Aorta Injury, Thoracic Aortic Dissection
- Trial name
- NCT05414318
- Testing
- Conformable GORE® TAG® Thoracic Endoprosthesis
- Volunteers
- 55 people
- Sponsor
- W.L.Gore & Associates
Peripheral Arterial Disease
GORE® VIABAHN® Endoprosthesis Post-Marketing Surveillance Study (JPS 16-03)
This study will confirm device efficacy and safety in the clinical setting after the launch of the GORE® VIABAHN® Endoprosthesis for the treatment of symptomatic peripheral arterial disease in the superficial femoral arteries.
- Trial name
- NCT04706273
- Testing
- GORE® VIABAHN® Endoprosthesis
- Where
- Japan
- Volunteers
- 321 people
- Sponsor
- W.L.Gore & Associates
Aortic Aneurysm, Abdominal
Evaluation of the GORE® C3 Delivery System Module
This is an observational Registry designed to obtain early data on the use of the GORE® EXCLUDER® AAA Endoprosthesis with C3 Delivery System.
- Trial name
- NCT01398332
- Testing
- Stent graft (EXCLUDER)
- Where
- Germany
- Volunteers
- 399 people
- Sponsor
- W.L.Gore & Associates
Aortic Aneurysm, Thoracic, Descending Thoracic Aortic Dissection
GORE® TAG® Thoracic 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® TAG® Thoracic Endoprosthesis treating diseases of the thoracic aorta.
- Conditions
- Aortic Aneurysm, Thoracic, Descending Thoracic Aortic Dissection, Aortic Diseases, Aorta Thoracic; Traumatic Rupture
- Trial name
- NCT02266342
- Testing
- GORE® TAG® Thoracic Endoprostheses
- Where
- France
- Volunteers
- 154 people
- Sponsor
- W.L.Gore & Associates
Pancreatitis, Chronic, Stricture; Bile Duct
GORE® VIABIL® Biliary Endoprosthesis in the Treatment of Benign Biliary Strictures Secondary to Chronic Pancreatitis
This study will evaluate the safety and effectiveness of the GORE® VIABIL® Biliary Endoprosthesis in the treatment of benign biliary strictures secondary to Chronic Pancreatitis (CP).
- Trial name
- VIABILITY (NCT05820009)
- Testing
- GORE® VIABIL® Biliary Endoprosthesis, GORE® VIABIL® Short Wire Biliary Endoprosthesis
- Where
- 2 sites in United States
- Volunteers
- 133 people
- Sponsor
- W.L.Gore & Associates