Clinical trials: Dissection Aortic Aneurysm
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.
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 Dissection
GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections
To assess the safety and effectiveness of the ASG device in the treatment of de novo Type A aortic dissections.
- Trial name
- ARISE III (NCT06827990)
- Testing
- GORE® Ascending Stent Graft (ASG device)
- Where
- 22 sites in United States
- Volunteers
- 112 people
- Sponsor
- W.L.Gore & Associates
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
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.
Aortic Dissection
A Real-World Study on Distal Aortic Remodeling for Stanford Type B Aortic Dissection With Fabulous Thoracic Aortic Stent System
To evaluate aortic remodeling of Fabulous thoracic aortic stent system in the treatment of acute and subacute Stanford type B aortic dissection (the changes of aortic diameter, cross-sectional area,and volume of true lumen, false…
- Trial name
- NCT05883592
- Testing
- Fabulous Thoracic Aortic Stent System
- Where
- 2 sites in China
- Volunteers
- 50 people
- Sponsor
- Hangzhou Endonom Medtech Co., Ltd.
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
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
Aortic Dissection
Study on the Aortic Arch Single Branch Stent Graft System
The objective of the study is to evaluate the Safety and Efficacy of Aortic Arch Single Branch Covered Stent System for Aortic Dissection Involving the Aortic Arch
- Trial name
- NCT06915545
- Testing
- Aortic Arch Single Branch Covered Stent System
- Where
- China
- Volunteers
- 135 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
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.
Aortic Dissection
Zenith® TXD Post-market Surveillance in Japan
The study is a post-market surveillance study required by Japanese Regulatory Authorities as a condition of approval
- Trial name
- NCT02663739
- Testing
- Zenith® TXD
- Where
- 27 sites in Japan
- Volunteers
- 57 people
- Sponsor
- Cook Group Incorporated
Acute Aortic Dissection
PERSEVERE- A Trial to Evaluate AMDS in Acute DeBakey Type I Dissection
Prospective, non-randomized, multicenter clinical investigation to assess the safety and effectiveness of AMDS in the treatment of patients with acute DeBakey type I dissection, with evidence of malperfusion, through open…
- Trial name
- PERSEVERE (NCT05174767)
- Testing
- AMDS
- Where
- 25 sites in United States
- Volunteers
- 115 people
- Sponsor
- Artivion Inc.
Aortic Dissection
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study
To determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion.
- Trial name
- FLAGSHIP_NZL (NCT06550986)
- Testing
- False Lumen Embolization System, IMPEDE-FX RapidFill
- Where
- 2 sites in New Zealand
- Volunteers
- 30 people
- Sponsor
- Shape Memory Medical, Inc.
Aortic Valve Disease, Ascending Aorta Abnormality
Valved Graft PMCF Study
Multicenter, global, prospective, non-randomized, interventional, post-market trial. All subjects enrolled will receive an Abbott Valved Graft device.
- Conditions
- Aortic Valve Disease, Ascending Aorta Abnormality, Aortic Dissection
- Trial name
- NCT04754217
- Testing
- VAVGJ, CAVGJ
- Where
- 25 sites in United States, Austria and 8 more
- Volunteers
- 260 people
- Sponsor
- Abbott Medical Devices
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.
Aortic Dissection, Aortic Aneurysm
PMCF Study in Patients With Acute or Chronic Aortic Dissection or Aortic Aneurysm Treated With E-vita OPEN NEO
The NEOS-APAC post-market clinical follow-up study is undertaken to demonstrate the safety and clinical performance of E-vita OPEN NEO in the treatment of aneurysm or dissection in the ascending aorta, aortic arch and descending…
- Trial name
- NEOS-APAC (NCT04986709)
- Testing
- Open repair
- Where
- 10 sites in Australia, Hong Kong and 4 more
- Volunteers
- 114 people
- Sponsor
- JOTEC GmbH
Vascular Ehlers-Danlos Syndrome
Investigate Efficacy, Safety, and Pharmacokinetics of Enzastaurin for the Prevention of Arterial Events in Patients With Vascular Ehlers-Danlos Syndrome.
The purpose of this study is to investigate the efficacy of enzastaurin compared to placebo in preventing arterial events (rupture, dissection, pseudoaneurysm, carotid-cavernous sinus fistula, or aneurysm, fatal or not) leading…
- Trial name
- PREVEnt (NCT05463679)
- Testing
- Enzastaurin
- Where
- United States
- Volunteers
- 260 people
- Sponsor
- Aytu BioPharma, Inc.
Thoracic Aortic Dissection
Post-market Clinical Trial of the Dominus® Stent-Graft
Real-world clinical trial evidence post-market, evaluating the safety and efficacy of the Dominus® StentGraft Endoprosthesis in treating thoracic aortic diseases, following the Instructions for Use
- Trial name
- DominusPMCF (NCT06270537)
- Testing
- Stent-Graft Dominus® Endoprosthesis
- Where
- 3 sites in Brazil
- Volunteers
- 100 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.
Aortic Dissection
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study (FLAGSHIP_FRA)
To determine the safety and feasibility of investigational product to reduce aortic dissection false lumen perfusion.
- Trial name
- FLAGSHIP_FRA (NCT06740721)
- Testing
- False Lumen Embolization System, IMPEDE-FX RapidFill
- Volunteers
- 15 people
- Sponsor
- Shape Memory Medical, Inc.
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