Clinical trials: Thoracic Aortic Disease
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
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
Thoracic Aortic Aneurysms, and Penetrating Atherosclerotic Ulcers
Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
The purpose of this study is to evaluate the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms.
- Trial name
- NCT00435942
- Testing
- Relay Thoracic Stent-Graft, Open Repair
- Where
- 27 sites in United States
- Volunteers
- 180 people
- Sponsor
- Bolton Medical
Thoracic Aortic Diseases
The Single Branch NEXUS™ Clinical Study
A prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Subjects will be followed-up for five years.
- Trial name
- NexusSB (NCT03208504)
- Testing
- Nexus™ Aortic Arch Stent graft
- Where
- Germany
- Volunteers
- 1 people
- Sponsor
- Endospan Ltd.
Aortic Aneurysm
ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry)
The ANCHOR registry is a multi-center, post-market, non-interventional, non-randomized, prospective study. Subjects must sign an ICF prior to obtaining any study specific information.
- Trial name
- ANCHOR (NCT01534819)
- Testing
- EndoAnchor™, endovascular treament
- Where
- 87 sites in United States, Australia and 11 more
- Volunteers
- 1,090 people
- Sponsor
- Medtronic Cardiovascular
Aortic Aneurysm, Aortic Dissection
Clinical Investigation of Clinical Safety and Performance of the SP-GRIPFLOW, Selective Cerebral Perfusion Catheter When Used for Cerebral Perfusion During Aortic Arch Repair
The purpose of this study is to determine if the SP-GRIPFLOW catheter (the catheter designed by Fuji Systems) is safe and how well it functions.
- Conditions
- Aortic Aneurysm, Aortic Dissection, Aortic Arch Aneurysm, Aortic Arch; Aneurysm, Dissecting
- Trial name
- NCT05421130
- Testing
- Selective Cerebral Perfusion Catheter
- Where
- 5 sites in Germany, Netherlands
- Volunteers
- 149 people
- Sponsor
- Fuji Systems Corporation
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
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
Thoracic Aortic Aneurysm
Valor II: The Valiant Thoracic Stent Graft System Clinical Study
This study was designed to study safety and effectiveness of the Valiant Thoracic Stent Graft to treat thoracic aortic aneurysms.
- Trial name
- NCT00413231
- Testing
- Valiant Thoracic Stent Graft System
- Where
- 26 sites in United States
- Volunteers
- 160 people
- Sponsor
- Medtronic Cardiovascular
Thoracic Aortic Aneurysm, Penetrating Aortic Ulcer
Zenith Thoracic Alpha (ZTA) Post-Market Data Collection
This study aims to gather real-world clinical data demonstrating the continued safety and performance of the a marketed stent graft (Zenith® Alpha Thoracic Endovascular Graft [ZTA]) and collect longer term follow-up to better…
- Trial name
- NCT06094127
- Testing
- Endovascular aortic treatment
- Where
- 10 sites in France, Germany and 2 more
- Volunteers
- 300 people
- Sponsor
- Cook Research Incorporated
Dissection of Aorta, Aneurysm Aortic
Retrospective Real-World Data Collection of the Conformable GORE® TAG® Thoracic Endoprosthesis When Used in Frozen Elephant Trunk Procedures for Treatment of Aortic Aneurysms and Dissections
Retrospective, multicenter, single-arm registry data collection designed to characterize outcomes in patients treated with the Conformable GORE® TAG® Thoracic Endoprosthesis deployed in an antegrade fashion as part of a frozen…
- Conditions
- Dissection of Aorta, Aneurysm Aortic, Frozen Elephant Trunk
- Trial name
- NCT07742592
- Testing
- Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure
- Volunteers
- 350 people
- Sponsor
- W.L.Gore & Associates
Aortic Arch Dissection, Aortic Arch Aneurysm
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
A prospective multi-center post-market study collecting outcomes through at least 5-years and up to 10-years post procedure for subjects treated with the TBE Device in Zone 0/1 as part of routine clinical practice.
- Trial name
- NCT07166133
- Testing
- GORE® TAG® Thoracic Branch Endoprosthesis
- Where
- 24 sites in United States
- Volunteers
- 125 people
- Sponsor
- W.L.Gore & Associates
Aortic Aneurysm, Thoracic
VALIANT CAPTIVIA Post-market Registry
The Valiant Thoracic Stent Graft has been preloaded on the new Captivia Delivery System (Captivia). This new delivery system was CE marked on September 14th, 2009 and was commercially released in the European Union on October…
- Trial name
- VCOUS (NCT01181947)
- Testing
- TEVAR
- Where
- 15 sites in Austria, Germany and 5 more
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiovascular
Dissection of Thoracic Aorta, Dissection of Thoracic Descending Aorta
European Multi-Centre Post-Market Registry on Thoracic Endovascular Arch Repair Using Castor™ and Cratos™
The Castor™ and Cratos™ Branched Aortic Stent Graft Systems are medical devices designed for the minimally invasive endovascular treatment of thoracic aortic pathologies in the descending aorta.
- Conditions
- Dissection of Thoracic Aorta, Dissection of Thoracic Descending Aorta, Aneurysm of Aorta, Thoracic, Penetrating Aortic Ulcers (PAUs)
- Trial name
- CEDAR (NCT07668687)
- Testing
- Implantation with Castor™ stent graft, Implantation with Cratos™ stent graft
- Where
- 4 sites in Germany, Switzerland
- Volunteers
- 100 people
- Sponsor
- Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
Thoracic Aortic Aneurysm
ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial
Evaluate the safety and effectiveness of endovascular repair with the LeMaitre TAArget thoracic stent graft as an alternative to open surgical repair.
- Trial name
- NCT01033214
- Testing
- Endovascular repair of TAA in the descending Thoracic Aorta
- Where
- 2 sites in United States
- Volunteers
- 30 people
- Sponsor
- Duke Vascular, Inc.
Cardiac Arrythmias, Unstable Angina
CardioSenseSystem Compared Study Regarding Efficacy and Safety in the Monitoring of ECG
This is a prospective, controlled, comparative clinical trial of a new ECG monitoring system CardioSenseSystem prior CE marking.
- Conditions
- Cardiac Arrythmias, Unstable Angina, Heart Valve Disorders, Disorder of Aorta
- Trial name
- NCT03610529
- Testing
- CardioSenseSystem, Philips Intellivue
- Where
- Sweden
- Volunteers
- 60 people
- Sponsor
- Novosense AB
Aortic Aneurysm, Thoracic, Chronic Type B Dissection
Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending TAA and Chronic Dissections
The purpose of the Feasibility study is to characterize the safety of the Valiant Mona LSA Thoracic Stent Graft System, including an assessment of the safety and effectiveness of the device acutely and at the 30 day visit in the…
- Trial name
- NCT02365467
- Testing
- Valiant Mona LSA Thoracic Stent Graft System
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Medtronic Cardiovascular
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 Diseases
INSTEAD Trial: INvestigation of STEnt Grafts in Patients With Type B Aortic Dissection
The objective of this study is to compare treatment with an endograft prothesis versus antihypertensive treatment in patients with a dissection of the thoracic aorta.
- Trial name
- INSTEAD (NCT00525356)
- Testing
- Medtronic Talent Stent-Graft-System
- Where
- Netherlands
- Volunteers
- 136 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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