Clinical trials: Aortic Aneurysm and Dissection
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
- 22 sites in United States
- Volunteers
- 125 people
- Sponsor
- W.L.Gore & Associates
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
The registry population consists of patients presenting with complex aortic pathologies amenable to endovascular aortic repair that requires the incorporation of bridging stents to maintain visceral artery perfusion
- Conditions
- Complex Aortic Aneurysms, Thoracoabdominal Aneurysm, Fenestrated Endovascular Aortic Repair, Endovascular Aortic Repair
- Trial name
- ENVISION (NCT07480395)
- Where
- 26 sites in Austria, Denmark and 8 more
- Volunteers
- 400 people
- Sponsor
- W.L.Gore & Associates
Aortic Arch Aneurysm, Aortic Arch Dissection
Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
The goal of this clinical trial is to learn if the Arcevo LSA stent graft can safely and effectively treat patients that have an acute or chronic aortic dissection and/or aneurysm that involves the aortic arch and the descending…
- Conditions
- Aortic Arch Aneurysm, Aortic Arch Dissection, Chronic Aortic Dissection, Acute Aortic Dissection
- Trial name
- ARTIZEN (NCT07089576)
- Testing
- Arcevo™ LSA Hybrid Stent Graft System
- Where
- 26 sites in United States, Germany and 1 more
- Volunteers
- 132 people
- Sponsor
- Artivion Inc.
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
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.
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
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
Aneurysm, Dissection, Aortic
Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis
The goal of this observational study is to collect mid-term post-market clinical follow-up data of GORE® TAG® Thoracic Branch Endoprosthesis used according to the standard medical practice in patients presenting with vascular…
- Conditions
- Aneurysm, Dissection, Aortic, TAA Thoracoabdominal Aortic Aneurysm, Thoracic Aortic Aneurysm
- Trial name
- NCT06507865
- Testing
- GORE® TAG® Thoracic Branch Endoprosthesis
- Where
- 19 sites in Austria, Denmark and 7 more
- Volunteers
- 155 people
- Sponsor
- W.L.Gore & Associates
Aortic Aneurysm, Aortic Aneurysm and Dissection
A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the Aorta
The Goal of this Clinical Study is to evaluate the safety and effectiveness of the Rapidlink device in the repair or replacement of the supra-aortic vessels during open surgical repair of aortic disease affecting the thoracic…
- Conditions
- Aortic Aneurysm, Aortic Aneurysm and Dissection, Aortic Diseases, Aneurysm of Aorta, Thoracic
- Trial name
- RAPID (NCT07078383)
- Testing
- Rapidlink
- Where
- 21 sites in United States, Austria and 3 more
- Volunteers
- 150 people
- Sponsor
- Vascutek Ltd.
Aneurysm of Aorta, Thoracic, Dissection of Aorta, Thoracic
TBE Zone 0/1 PMS in Japan
The goal of this surveillance is to confirm the safety and efficacy of TBE under actual use in the Zone 0/1 lesion on post-marketing usage conditions.
- Conditions
- Aneurysm of Aorta, Thoracic, Dissection of Aorta, Thoracic, Trauma
- Trial name
- NCT07691931
- Testing
- Gore® TAG® Thoracic Aortic Branch Stent Graft System
- Volunteers
- 75 people
- Sponsor
- W.L.Gore & Associates
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
Complex Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm
European Aortic Data Collection Project
The purpose of this study is to evaluate the safety and performance of Cook's various Custom-Made Stent-graft Devices (CMD) used for endovascular treatment of the aorta and related diseases by collecting information on the…
- Conditions
- Complex Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Aortic Arch Aneurysm, Chronic Aortic Dissection
- Trial name
- EADC (NCT05896397)
- Testing
- Endovascular Aortic Treatments
- Where
- 18 sites in Denmark, France and 4 more
- Volunteers
- 600 people
- Sponsor
- Cook Research Incorporated
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
Aneurysm Thoracic, Dissection of Thoracic Aorta
Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study
The purpose of this study is to collect clinical data on patient outcomes, evaluate the safety and performance of Ankura TAA Stent Graft System and Surpass Super Stiff Guidewire, and build clinical evidence for patients with…
- Trial name
- NCT05639569
- Testing
- Ankura™ TAA Stent Graft System
- Where
- 15 sites in Germany, Greece and 3 more
- Volunteers
- 147 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Aortic Aneurysm, Aortic Aneurysm Abdominal
AI-CARE: Artificial Intelligence for Cardiovascular Analysis and Risk Evaluation
This study will test how well an artificial intelligence (AI) software called Aorta AIM measures the size of the aorta (the body's main blood vessel) from CT scans.
- Conditions
- Aortic Aneurysm, Aortic Aneurysm Abdominal, Aortic Aneurysm and Dissection, Aortic Aneurysm, Thoracoabdominal
- Trial name
- AI-CARE (NCT07438327)
- Testing
- Aorta AIM Automated Measurement, Expert Radiologist Manual Measurement
- Where
- 3 sites in United States, Brazil
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Aiatella Oy
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.
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, Aortic Aneurysm
NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness
Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native…
- Conditions
- Aortic Dissection, Aortic Aneurysm, Intramural Hematoma, Penetrating Aortic Ulcer
- Trial name
- TRIOMPHE (NCT04471909)
- Testing
- NEXUS Aortic Stent Graft System
- Where
- 32 sites in United States, New Zealand
- Volunteers
- 110 people
- Sponsor
- Endospan Ltd.
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
Acute Aortic Dissection, Aortic Rupture
Thoraflex Hybrid Post-Market Study
This is a global, prospective non-interventional, multi-centre, post-market study of the Vascutek Thoraflex™ Hybrid system in patients with acute thoracic aortic syndrome, subacute/chronic dissection of the aorta and aortic…
- Conditions
- Acute Aortic Dissection, Aortic Rupture, Penetrating Aortic Ulcer, Aortic Dissection
- Trial name
- THOR (NCT03414866)
- Testing
- EQ-5D-5L QOL questionnaire
- Where
- 7 sites in Canada, Germany and 2 more
- Volunteers
- 182 people
- Sponsor
- Vascutek Ltd.