Clinical trials: Aortic Aneurysms
Thoracic Aortic Dissection
Prospective Study for Aortic Arch Therapy With stENt-graft for Chimney technologY（PATENCY）
A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of Artery Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD.
- Trial name
- NCT03767777
- Testing
- Artery Stent Graft System
- Where
- 21 sites in China
- Volunteers
- 150 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
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.
Preventive Medicine, Multi Organ Failure
Efficacy and Safety of FP-1201-lyo (Interferon Beta-1a) in Prevention of Multi-Organ Failure on Patients After Open Surgery for a RAAA
A study to assess effectiveness and safety of a drug FP-1201-lyo (Recombinant Human Interferon Beta-1a) in the Prevention of Multi-Organ Failure on patients after Open Surgery for a Ruptured Abdominal Aortic Aneurysm
- Trial name
- INFORAAA (NCT03119701)
- Testing
- Interferon Beta-1A
- Where
- 9 sites in Estonia, Finland and 1 more
- Volunteers
- 40 people
- Sponsor
- Faron Pharmaceuticals Ltd
Abdominal Aortic Aneurysm
Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices
The objective of this post-market trial is to evaluate Endologix AFX endovascular AAA system with anatomical fixation against other approved Endovascular systems with proximal fixation.
- Trial name
- LEOPARD (NCT02407457)
- Testing
- AFX EVAR AAA Graft System, FDA Approved EVAR AAA Graft Systems
- Where
- 56 sites in United States
- Volunteers
- 455 people
- Sponsor
- Endologix
Aneurysm, Abdominal Aortic
First-in-Human Trial of the A3-Shield System for Stabilizing Abdominal Aortic Aneurysms
This clinical trial evaluates the safety and feasibility of the A3-Shield implant for stabilising small abdominal aortic aneurysms in adult patients.
- Trial name
- PRINCIPIIS-FIH (NCT07330752)
- Testing
- A3-Shield Implantation
- Where
- Uzbekistan
- Volunteers
- 12 people
- Sponsor
- Angiolutions GmbH
Aortic Aneurysm, Abdominal Aortic Aneurysm
Zenith® p-Branch™: Single-Center Study
The Zenith® p-Branch™: Single-Center Study is a clinical trial approved by Swedish Regulatory Authority to study the safety and effectiveness of the Zenith® p-Branch™ in the treatment of abdominal aortic aneurysms.
- Trial name
- PBCT (NCT01663064)
- Testing
- Endovascular treatment (Zenith® p-Branch™ endovascular graft)
- Where
- Sweden
- Volunteers
- 23 people
- Sponsor
- Cook Group Incorporated
Abdominal Aortic Aneurysm (AAA)
Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix® System
The objective of this study is to assess the safety and effectiveness of the Endologix Nellix® System for the endovascular repair of infrarenal abdominal aortic aneurysms (AAA).
- Trial name
- EVAS1 (NCT01726257)
- Testing
- Nellix System
- Where
- 30 sites in United States, Germany and 2 more
- Volunteers
- 333 people
- Sponsor
- Endologix
Complex Abdominal Aortic Aneurysms
Clinical Performance and Safety Assessment of the Use of iCover Balloon Expandable Covered Stent (iVascular) Implanted as Bridging Stent in FEVAR (Fenestrated Endovascular Aortic Repair) for the Treatment of Complex Abdominal Aortic Aneurysms
fenCo is a European multicentre, prospective study to evaluate the use of the iCover covered stents as bridging stents for reno-visceral target vessel during fEVAR for the treatment of complex abdominal aortic aneurysms.
- Trial name
- fenCo (NCT07529275)
- Testing
- iCover balloon-expandable covered peripheral stent system as bridging stent
- Where
- 24 sites in Belgium, France and 3 more
- Volunteers
- 165 people
- Sponsor
- iVascular S.L.U.
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
Abdominal Aorta Aneurysm
Performance and Safety of a Second Generation Antimicrobial Graft in Abdominal Position
Safety and performance of an anti-microbial vascular graft in the treatment of aneurysmal and occlusive disease of the abdominal aorta.
- Trial name
- SYNERGY (NCT01710878)
- Testing
- Intergard Synergy Graft
- Where
- 8 sites in France, Germany
- Volunteers
- 60 people
- Sponsor
- Maquet Cardiovascular
Aortic Aneurysm, Thoracoabdominal
Post-market Observational Study Zenith® t-Branch™
The Zenith® t-Branch™ Thoracoabdominal Endovascular Graft Study is a post-market observational study to evaluate the performance of the Zenith® t-Branch™ in the treatment of thoracoabdominal aortic aneurysms in routine care.
- Trial name
- NCT02104089
- Testing
- Zenith® t-Branch™ Thoracoabdominal Endovascular Graft
- Where
- 3 sites in Germany, Sweden
- Volunteers
- 80 people
- Sponsor
- Cook Group Incorporated
Abdominal Aortic Aneurysm
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks
To determine the safety and efficacy of IMPEDE-FX Embolization Plug and/or IMPEDE-FX Rapid Fill to fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft.
- Trial name
- AAA-SHAPE (NCT04227054)
- Testing
- IMPEDE-FX Embolization Plug
- Where
- 2 sites in New Zealand
- Volunteers
- 15 people
- Sponsor
- Shape Memory Medical, Inc.
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 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.
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 Aneurysm, Abdominal
Post-Approval Trial of the Talent™ Abdominal Stent Graft to Treat Aortic Aneurysms
The purpose of this study is to examine, through the endpoints established in this protocol, the long-term safety and effectiveness of the Talent Abdominal Stent Graft System, in a post-approval environment.
- Trial name
- VITALITY (NCT00816062)
- Testing
- Talent Abdominal Stent Graft
- Where
- 18 sites in United States
- Volunteers
- 94 people
- Sponsor
- Medtronic Cardiovascular
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
Abdominal Aortic Aneurysms
European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms
INSIGHT is a postmarket clinical follow-up study in the European Union. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of INCRAFT in subjects with abdominal aortic aneurysms requiring…
- Trial name
- INSIGHT (NCT02477111)
- Testing
- Endovascular abdominal aortic aneurysm repair
- Where
- 23 sites in France, Germany and 6 more
- Volunteers
- 150 people
- Sponsor
- Cordis US Corp.
Abdominal Aortic Aneurysms
China Post-market Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INITIATION)
INITIATION is a postmarket clinical follow-up study in China. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of Incraft in subjects with abdominal aortic aneurysms requiring…
- Trial name
- NCT03965364
- Testing
- INCRAFT
- Where
- China
- Sponsor
- Cordis US Corp.