Clinical trials: Thoracic Aortic Aneurysms
Aortic Dissection
Study to Evaluate the Clinical Performance of the Valiant Thoracic Stent Graft With the Captivia Delivery System (Valiant Captivia) for the Treatment of Acute, Complicated Type B Aortic Dissections
The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a thoracic dissection.
- Trial name
- NCT01114724
- Testing
- Valiant Thoracic Stent Graft with the Captivia Delivery System
- Where
- 17 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic Cardiovascular
Aortic Dissection
The VIRTUE Post Marketing Surveillance Registry
The purpose of this post-market release registry is to collect additional information concerning safety, performance and health economic data with respect to the Medtronic VALIANT Thoracic Stent Graft with the Xcelerant Delivery…
- Trial name
- VIRTUE (NCT01213589)
- Volunteers
- 100 people
- Sponsor
- Medtronic Endovascular
Aneurysm, Dissection
PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
The purpose of this registry is to collect safety and performance data on all commercially available Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice.
- Conditions
- Aneurysm, Dissection, Aortic Root Aneurysm, Aortic Root Dissection
- Trial name
- PANTHER (NCT04545502)
- Testing
- Gelsoft Plus Vascular Graft, Vascular Bypass Graft, Cardiovascular Patch
- Where
- 30 sites in United States, Belgium and 4 more
- Volunteers
- 2,000 people
- Sponsor
- Vascutek Ltd.
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
Thoracic Diseases, Aortic Aneurysm
Thoraflex Hybrid and Relay Extension Post-Approval Study
The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or…
- Conditions
- Thoracic Diseases, Aortic Aneurysm, Aortic Dissection, Thoracic Aortic Aneurysm
- Trial name
- EXTEND (NCT05639400)
- Testing
- Thoraflex Hybrid, RelayPro NBS
- Where
- 27 sites in United States, Austria and 5 more
- Volunteers
- 352 people
- Sponsor
- Vascutek Ltd.
Thoracic Aortic Aneurysms
Safety and Efficacy of Valiant Mona LSA Stent Graft System
The Valiant Mona LSA thoracic stent graft system is for the endovascular repair of aneurysms of the descending thoracic aorta (DTA) in patients who require coverage of the left subclavian artery (LSA).The study is intended to…
- Trial name
- NCT01839695
- Testing
- Valiant Mona LSA Stent Graft System
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 9 people
- Sponsor
- Medtronic Cardiovascular
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
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
Abdominal Aortic Aneurysm, Thoracic Aortic Aneurysm
Terumo Aortic Global Endovascular Registry
Multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts.
- Conditions
- Abdominal Aortic Aneurysm, Thoracic Aortic Aneurysm, Surgery
- Trial name
- TiGER (NCT04246463)
- Testing
- Thoracic, Abdominal, Custom Device
- Where
- 58 sites in United States, Belgium and 8 more
- Volunteers
- 1,000 people
- Sponsor
- Vascutek Ltd.
Aortic Aneurysm, Thoracic, Penetrating Ulcer
RelayPro Thoracic Stent-Graft in Subjects With Thoracic Aortic Aneurysms and Penetrating Atherosclerotic Ulcers
Investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU) of the descending thoracic aorta.
- Trial name
- RelayPro-A (NCT02818972)
- Testing
- RelayPro
- Where
- 35 sites in United States, Japan
- Volunteers
- 110 people
- Sponsor
- Bolton Medical
Thoracic Aortic Aneurysms
Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE)
The purpose of this study is to evaluate the long-term safety and effectiveness of the Talent Thoracic Stent Graft System for treatment of descending thoracic aneurysms (DTA)following U.S. market approval.
- Trial name
- THRIVE (NCT00805948)
- Testing
- Talent Thoracic Stent Graft System
- Where
- 26 sites in United States
- Volunteers
- 349 people
- Sponsor
- Medtronic Cardiovascular
Descending Thoracic Aortic Aneurysm
Zenith TX2® Post-market Approval Study
The Zenith TX2® Post-market Approval Study is a clinical trial approved by US FDA to further study the safety and effectiveness of the Zenith TX2® TAA Endovascular Graft in the treatment of thoracic aortic aneurysms.
- Trial name
- TX2 2PAS (NCT00813358)
- Testing
- Zenith TX2® TAA Endovascular Graft
- Where
- 25 sites in United States, Canada
- Volunteers
- 115 people
- Sponsor
- Cook Research Incorporated
Aorta, Thoracic Pathologies, Aortic Aneurysm, Thoracic
RE-GENERATION: The Safety and Performance of the Relay Pro and Relay NBS Pro Stent-graft Devices in the European Union (EU)
The objective of the study is to evaluate the safety and performance of Relay Pro and Relay NBS Pro devices in humans having thoracic aortic pathologies. Clinical results will be used to apply for the CE certification.
- Conditions
- Aorta, Thoracic Pathologies, Aortic Aneurysm, Thoracic, Aortic Aneurysm
- Trial name
- RE-GENERATION (NCT03207568)
- Testing
- Thoracic Endovascular Aortic Repair (TEVAR)
- Volunteers
- 30 people
- Sponsor
- Bolton Medical
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
Vascular Diseases
Prospective/Retrospective Registry of the E-vita OPEN PLUS Stent Graft System in France
The FEOR registry is undertaken to examine the real-world data of patients that were treated with the E-vita OPEN Plus Stent Graft System under routine care in France.
- Trial name
- FEOR (NCT04058691)
- Testing
- Surgical repair
- Where
- 2 sites in France
- Volunteers
- 100 people
- Sponsor
- JOTEC GmbH
Aortic Valve Stenosis, Aneurysm of Ascending Aorta
Progel Vascular Sealant
This study is being conducted to evaluate the safety and effectiveness of the Progel Vascular Sealant for use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
- Conditions
- Aortic Valve Stenosis, Aneurysm of Ascending Aorta, Aortic Valve Disorder, Bicuspid Valve Disorder
- Trial name
- NCT01959503
- Testing
- Progel Vascular Sealant, Gelfoam Plus
- Where
- 19 sites in United States
- Volunteers
- 158 people
- Sponsor
- C. R. Bard
Aortic Aneurysm, Thoracic
Valiant Evo US Clinical Trial
The purpose of the Valiant Evo US Clinical Trial is to demonstrate the safety and effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending thoracic aortic aneurysm (DTAA) who are candidates for…
- Trial name
- VEVO (NCT02652949)
- Testing
- Valiant Evo Thoracic Stent Graft System
- Where
- 21 sites in United States
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiovascular
Aortic Aneurysm, Thoracoabdominal, Thoracoabdominal Aortic Aneurysm
Evaluation of the Safety and Efficacy of the Multilayer Stent
Evaluation of the Multilayer Flow Modulator (MFM) for Endovascular Thoracoabdominal Aneurysm Repair. The objectives of the study is to determine the efficacy, safety and performance of the MFM and its delivery system in patients…
- Conditions
- Aortic Aneurysm, Thoracoabdominal, Thoracoabdominal Aortic Aneurysm, Aortic Aneurysm, Thoracic
- Trial name
- STRATO (NCT01756911)
- Testing
- MFM
- Where
- 9 sites in France
- Volunteers
- 23 people
- Sponsor
- Cardiatis
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 Dissection
Zenith® Dissection Clinical Trial
The Zenith® Dissection Clinical Trial is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection.
- Trial name
- NCT01568320
- Testing
- Endovascular Treatment (Zenith)
- Where
- 24 sites in United States, Japan
- Volunteers
- 73 people
- Sponsor
- Cook Research Incorporated