Clinical trials: Aortic Diseases
Aortic Valve Stenosis
Engager Align Post-market Clinical Study
Purpose To characterize the safety and clinical benefit of the Engager Transcatheter Aortic Valve Implantation System in a real world environment.
- Trial name
- NCT02149654
- Testing
- Engager Transcatheter Aortic Valve Implantation System
- Where
- Netherlands
- Volunteers
- 27 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Blunt Thoracic Aortic Injury
Study to Determine if the Valiant Stent Graft is Safe and Effective in Treating Patients Who Have a Blunt Thoracic Aortic Injury
The purpose of this study is to determine if the Valiant stent graft is safe and effective in treating patients who have a blunt thoracic aortic injury (BTAI).
- Trial name
- RESCUE (NCT01092767)
- Testing
- Valiant Thoracic Stent Graft with the Captivia Delivery System
- Where
- 25 sites in United States, Canada
- Volunteers
- 50 people
- Sponsor
- Medtronic Cardiovascular
Aortic Aneurysm
Haemocomplettan® P During Aortic Replacement
The primary purpose is to show that administration of Haemocomplettan® P significantly reduces the amount of blood products needed during aortic surgery.
- Trial name
- NCT00701142
- Testing
- Haemocomplettan® P, Saline solution
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- CSL Behring
Abdominal Aortic Aneurysm
Vascutek Anaconda™ Abdominal Aortic Aneurysm (AAA) Post-Market Surveillance Registry
The purpose of this observational Post-Market Surveillance Registry is to gather post-market data on the performance of the CE marked Vascutek Anaconda™ Stent Graft System for the repair of Abdominal Aortic Aneurysms (AAA).
- Trial name
- NCT01744119
- Testing
- Vascutek Anaconda™ Stent Graft System
- Where
- 21 sites in Australia, France and 5 more
- Volunteers
- 318 people
- Sponsor
- Vascutek Ltd.
Aortic Valve Insufficiency, Regurgitation, Aortic Valve
Aortic Valve Replacement With Trifecta(TM)
To confirm the clinical safety and effectiveness of the Trifecta valve.
- Conditions
- Aortic Valve Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence, Aortic Valve Stenosis
- Trial name
- NCT00475709
- Testing
- Trifecta Aortic Heart Valve
- Where
- 18 sites in United States
- Volunteers
- 1,022 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Disease
CENTERA-2: Safety and Performance Study of the Edwards CENTERA-EU Self-Expanding Transcatheter Heart Valve
The purpose of this study is to assess the safety and device success of the Edwards CENTERA Transcatheter Heart Valve (THV) System in symptomatic adult patients with severe aortic stenosis.
- Trial name
- NCT02458560
- Testing
- Edwards CENTERA Self-Expanding Transcatheter Heart Valve
- Where
- 27 sites in Australia, Denmark and 7 more
- Volunteers
- 203 people
- Sponsor
- Edwards Lifesciences
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 Aneurysms
Talent Aortic Cuff Stent Graft System Compassionate Use Registry
An evaluation of the TALENT Aortic Cuff in patients with existing AneuRx stent grafts who have experienced sub-optimal stent graft outcomes and are not deemed suitable candidates for treatment with an AneuRx Aortic Cuff.
- Trial name
- NCT00604643
- Testing
- TALENT Aortic Cuff Abdominal Stent Graft
- Where
- 50 sites in United States
- Sponsor
- Medtronic Cardiovascular
Vascular Diseases
Prospective/Retrospective Registry of the E-vita OPEN PLUS Stent Graft System in France
The FEOR registry is undertaken to examine the real-world data of patients that were treated with the E-vita OPEN Plus Stent Graft System under routine care in France.
- Trial name
- FEOR (NCT04058691)
- Testing
- Surgical repair
- Where
- 2 sites in France
- Volunteers
- 100 people
- Sponsor
- JOTEC GmbH
Aortic Stenosis
A Study of Transcatheter Aortic Valve Replacement Case Selection and Valve Sizing Using the ABC Bicuspid Sizing Algorithm
The goal of this study is to learn what effects the ABC Bicuspid Sizing Algorithm has on the clinical outcomes of patients with bicuspid aortic stenosis after having a transcatheter aortic valve replacement (TAVR) using the…
- Trial name
- NCT06991517
- Testing
- The ABC Bicuspid Sizing Algorithm
- Where
- 20 sites in Australia, Canada and 6 more
- Volunteers
- 290 people
- Sponsor
- World Health Research Inc.
AAA - Abdominal Aortic Aneurysm
Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis
A prospective, observational post-market registry collecting outcomes through a 10-year post procedure follow-up for patients treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device) or the GORE® EXCLUDER®…
- Trial name
- NCT06218875
- Where
- 90 sites in United States, Australia and 10 more
- Volunteers
- 2,000 people
- Sponsor
- W.L.Gore & Associates
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
Thoracoabdominal Aortic Aneurysms
Safety and Efficacy of a Multi-branched Thoracoabdominal Stent Graft System for Thoracoabdominal Aortic Aneurysm.
Evaluation of the safety and efficacy of a multi-branched thoracoabdominal stent graft system for thoracoabdominal aortic aneurysm.
- Trial name
- NCT05054985
- Testing
- Multi-Branched Thoracoabdominal Stent Graft System
- Where
- China
- Volunteers
- 73 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Aortic Valve Disease
Clinical Data Collection on Perceval S Sutureless Prosthetic Aortic Valve in the Chinese Population
The objective of the study is to evaluate the safety information on the Perceval S sutureless prosthetic heart valve after the implantation for aortic valve disease.
- Trial name
- NCT06011148
- Testing
- Perceval S sutureless heart valve
- Volunteers
- 80 people
- Sponsor
- Corcym S.r.l
Thoracic Aortic Aneurysm
STARZ-TX2 Clinical Study: Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft
The STARZ-TX2 trial (Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2(R) TAA [Thoracic Aortic Aneurysm] Endovascular Graft) is a clinical trial approved by the United States Food and Drug Administration (FDA) to study…
- Trial name
- STARZ-TX2 (NCT00111176)
- Testing
- Endovascular repair, Surgical
- Where
- 41 sites in United States, Canada and 1 more
- Volunteers
- 260 people
- Sponsor
- Cook Group Incorporated
Aortic Stenosis, Symptomatic Aortic Stenosis
China S3: Safety and Effectiveness of Edwards Lifesciences SAPIEN 3 THV in the Chinese Population
To evaluate the safety and effectiveness of the SAPIEN 3 (Edwards Lifesciences, Irvine, California) transcatheter heart valve implantation (TAVI) in Chinese patients with symptomatic severe calcific aortic stenosis who are…
- Conditions
- Aortic Stenosis, Symptomatic Aortic Stenosis, Aortic Regurgitation
- Trial name
- NCT03466918
- Testing
- SAPIEN 3 THV with the Commander delivery system
- Where
- 4 sites in China
- Volunteers
- 58 people
- Sponsor
- Edwards Lifesciences
Aortic Valve Disease, Aortic Stenosis, Severe
Valvosoft Outcomes Registry for Real-World Evidence
The VALvosoft Outcomes Registry for Real-World Evidence (VALOR-PMCF) is a prospective, multicenter, single-arm post-market clinical follow-up (PMCF) registry designed to evaluate the long-term safety and effectiveness of the…
- Conditions
- Aortic Valve Disease, Aortic Stenosis, Severe, Aortic Valve Calcification, Ultrasound Therapy
- Trial name
- VALOR-PMCF (NCT07520591)
- Testing
- Valvosoft Treatment
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 200 people
- Sponsor
- Cardiawave SA
Aneurysmal Disease of the Ascending Aorta, the Arch and the Proximal Descending Aorta
Evaluation of the Vascutek Hybrid Graft for Use in the Replacement of the Aortic Arch and Concomitant Treatment of an Aneurysm/Dissection of the Descending Aorta in the Frozen Elephant Trunk Procedure
The purpose of this feasibility study is to investigate the clinical performance of the Vascutek Hybrid Device in the treatment of subjects with aneurysm and/or dissection of the thoracic aorta.
- Trial name
- NCT01541410
- Testing
- Vascutek Hybrid Graft
- Where
- Germany
- Volunteers
- 34 people
- Sponsor
- Vascutek Ltd.
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
Aneurysm, Aortic Aneurysm
Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (ENDURANT France)
The purpose of this study is to assess the benefits of endovascular repair with Endurant Stent Graft System by documenting overall mortality, complications, the rate of conversion to open surgical repair, and the development and…
- Conditions
- Aneurysm, Aortic Aneurysm, Aortic Aneurysm, Abdominal, Vascular Diseases
- Trial name
- NCT01526811
- Testing
- Endurant Stent graft
- Where
- 20 sites in France
- Volunteers
- 180 people
- Sponsor
- Medtronic Cardiovascular