Clinical trials: Thoracic Aneurysm
Thoracic Aortic Dissection
DISSECT-N Post Market Data Collection Registry
DISSECT-N is a post-market registry designed to assess real-world safety and effectiveness of Valiant Navion Thoracic Stent Graft System in the treatment of thoracic aortic dissections in real world practice.
- Trial name
- DISSECT-N (NCT04267055)
- Testing
- Valiant Navion Thoracic Stent Graft System
- Where
- 22 sites in United States, Denmark and 8 more
- Volunteers
- 102 people
- Sponsor
- Medtronic Cardiovascular
Aortic Valve Disease
Post Market Clinical Follow-Up Study in Patients Treated With the On-X Ascending Aortic Prosthesis (AAP)
The ASCEND post-market clinical follow-up study is undertaken to evaluate safety and clinical performance of the On-X Ascending Aortic Prosthesis (AAP) used in surgical aortic valve replacement.
- Trial name
- ASCEND (NCT05082454)
- Testing
- Open repair
- Where
- 11 sites in United States, Germany and 3 more
- Volunteers
- 108 people
- Sponsor
- JOTEC GmbH
Aortic Aneurysm, Thoracic
Feasibility Study for GORE® TAG® Thoracic Branch Endoprosthesis to Treat Proximal Descending Thoracic Aortic Aneurysms
The purpose of this study is to assess the feasibility of the use of the GORE® TAG® Thoracic Branch Endoprosthesis to treat aneurysms involving the proximal Descending Thoracic Aorta (DTA)
- Trial name
- NCT02021812
- Testing
- GORE® TAG® Thoracic Branch Endoprosthesis
- Where
- 6 sites in United States
- Volunteers
- 31 people
- Sponsor
- W.L.Gore & Associates
Thoracic Aorta Aneurysm, Aneurysm, Ruptured
Early Feasibility Study of the RelayBranch Thoracic Stent-Graft System
The purpose of this study is to conduct an early clinical evaluation of the Relay Branch System, which will provide initial insight into the clinical safety and function of the device.
- Conditions
- Thoracic Aorta Aneurysm, Aneurysm, Ruptured, Aortic Aneurysm
- Trial name
- RelayBranch (NCT03214601)
- Testing
- penetrating atherosclerotic ulcer, aorta branch cardiovascular implant
- Where
- 12 sites in United States
- Volunteers
- 30 people
- Sponsor
- Bolton Medical
Aortic Dissection
Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissections
The Zenith® Dissection extended study is to collect confirmatory safety and effectiveness data on the Zenith® Dissection Endovascular System in the treatment of acute, complicate Type B aortic dissection.
- Trial name
- NCT02464943
- Testing
- Endovascular Treatment (Zenith)
- Where
- 3 sites in United States
- Sponsor
- Cook Research Incorporated
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 Aortic Aneurysm
South American Thoracic Stent-Graft Study
A prospective, non-randomized multi-center clinical evaluation of the performance of the TriVascular Thoracic Stent Graft System when used in the treatment of subjects with thoracic aortic aneurysms (TAA).
- Trial name
- NCT01082172
- Testing
- Implant Thoracic Stent Graft
- Where
- Chile
- Volunteers
- 2 people
- Sponsor
- TriVascular, Inc.
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 0/1
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.
- Trial name
- SSB 11-02 (NCT02777528)
- Testing
- GORE® TAG® Thoracic Branch Endoprosthesis, Revascularization Procedure
- Where
- 39 sites in United States, Japan
- Volunteers
- 79 people
- Sponsor
- W.L.Gore & Associates
Aortic Aneurysm, Thoracic, Pseudoaneurysm
Evaluation of the GORE® Ascending Stent Graft
The primary objective of ARISE II is to assess the safety and effectiveness of the GORE® Ascending Stent Graft device in the treatment of lesions involving the ascending aorta and aortic arch.
- Conditions
- Aortic Aneurysm, Thoracic, Pseudoaneurysm, Aortic Dissection, Aorta; Lesion
- Trial name
- ARISEII (NCT05800743)
- Testing
- GORE® Ascending Stent Graft (ASG device), GORE® Thoracic Aortic Graft Thoracic Branch Endoprosthesis (TBE Device), Surgery
- Where
- 41 sites in United States
- Volunteers
- 370 people
- Sponsor
- W.L.Gore & Associates
Thoracic Aortic Aneurysm, Penetrating Ulcers
Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
This study is a continuation of the pivotal trial studying the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms.
- Trial name
- NCT01327742
- Testing
- Relay Thoracic Stent-Graft
- Where
- 15 sites in United States
- Sponsor
- Bolton Medical
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
Vascular Aneurysm
French Registry Conducted on E-vita OPEN NEO
Observational, prospective/retrospective, non-randomised, non-comparative, multicentre cohort study. Primary objective is evaluation of in-hospital all-cause mortality after treatment of extensive acute and chronic aortic…
- Trial name
- NEO (NCT05721001)
- Testing
- Surgical Repair
- Where
- 23 sites in France
- Volunteers
- 130 people
- Sponsor
- JOTEC GmbH
Aortic Aneurysm, Aortic Aneurysm Abdominal
Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery
This clinical study aims to evaluate the effectiveness and safety of using NE'X Glue R-eco to seal suture lines. The adhesive will be applied to reduce the risk of suture line bleeding in cardiac or vascular repair surgeries, a…
- Conditions
- Aortic Aneurysm, Aortic Aneurysm Abdominal, Valve Stenoses, Aortic, Valve Regurgitation, Mitral
- Trial name
- CLOSURE (NCT06918496)
- Testing
- Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair.
- Where
- 2 sites in Belgium, Poland
- Volunteers
- 60 people
- Sponsor
- Grena Biomed Limited
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
Aortic Dissection
A Real World Study on Fabulous® Thoracic Aortic Stent System for Stanford B Aortic Dissection
A multicenter, retrospective study to evaluate the real-world efficacy of the Fabulous thoracic aortic stent system in the treatment of Stanford Type B aortic dissection.
- Trial name
- NCT05965271
- Testing
- Fabulous Thoracic Aortic Stent System
- Where
- 7 sites in China
- Volunteers
- 260 people
- Sponsor
- Hangzhou Endonom Medtech Co., Ltd.
Aortic Arch; Aneurysm, Dissecting
Study of the Thoraflex™ Hybrid Device for the Treatment of Aneurysm/Dissection of the Descending Thoracic Aorta
The purpose of this national observational study is to evaluate the Thoraflex™ Hybrid vascular prosthesis in the replacement of the aortic arch and the treatment of aneurysm/dissection of the descending thoracic aorta in relation…
- Trial name
- NCT03735472
- Testing
- Thoraflex™ Hybrid
- Where
- 37 sites in France
- Volunteers
- 351 people
- Sponsor
- Vascutek Ltd.
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
Pathology of the Thoracic Aorta, Aneurysm Thoracic
French Assessment of the Relay Plus and Relay NBS Plus Thoracic Stent-Graft
Stent treatment of thoracic aortic pathologies, including aneurysms, pseudo-aneurysms, dissections, intramural hematomas, penetrating ulcers and ruptures of the isthmus, seems to provide a likely benefit compared to surgery in…
- Conditions
- Pathology of the Thoracic Aorta, Aneurysm Thoracic, Pseudo-aneurysm, Thoracic, Dissection of Thoracic Aorta
- Trial name
- NCT05030740
- Where
- 10 sites in France
- Volunteers
- 170 people
- Sponsor
- Vascutek Ltd.
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
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