Clinical trials: Endovascular Repair
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
Abdominal Aortic Aneurysms (AAA)
The Pivotal Study of the Aptus Endovascular AAA Repair System
A prospective, non-randomized, multi-center clinical study to evaluate the safety and effectiveness of the Aptus Endovascular AAA Repair System compared to an open surgical repair historical control group in the treatment of…
- Trial name
- STAPLE-2 (NCT00507559)
- Testing
- Aptus Endovascular AAA Repair System
- Where
- 2 sites in United States
- Volunteers
- 155 people
- Sponsor
- Medtronic Cardiovascular
Abdominal Aortic Aneurysm Without Rupture
EVAS2 IDE Prospective, Multicenter, Single Arm Safety and Effectiveness Confirmatory Study
Prospective, multicenter, single arm study with consecutive, eligible subject enrollment at each site. All subjects will undergo the Endovascular Aneurysm repair procedure with the Nellix System.
- Trial name
- EVAS2 (NCT03298477)
- Testing
- Nellix® System
- Where
- 27 sites in United States
- Volunteers
- 98 people
- Sponsor
- Endologix
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
Abdominal Aortic Aneurysm
Percutaneous Endovascular Aneurysm Repair (PEVAR) Trial
To determine the safety and effectiveness of PEVAR.
- Trial name
- PEVAR (NCT01070069)
- Testing
- PEVAR (ProGlide closure), SEVAR (IntuiTrak), PEVAR (Prostar XL closure)
- Where
- 20 sites in United States
- Volunteers
- 192 people
- Sponsor
- Endologix
Aortic Aneurysm, Abdominal
Endurant Stent Graft System Post Approval Study (ENGAGE PAS)
The purpose of the study is to demonstrate the long term safety and effectiveness of the Endurant Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms in a post-approval environment, through…
- Trial name
- NCT01379222
- Testing
- Endurant Stent Graft System
- Where
- 24 sites in United States
- Volunteers
- 178 people
- Sponsor
- Medtronic Cardiovascular
Infrarenal Abdominal Aortic Aneurysms, Aortoiliac Aneurysms
HORIZON CE Pivotal Study to Treat Abdominal Aortic Aneurysm
Clinical Investigation Design A prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Patients will be followed-up for five years.
- Trial name
- NCT02087501
- Testing
- Horizon™ Abdominal Aortic Aneurysm Stent Graft System
- Where
- 7 sites in Italy, Netherlands and 2 more
- Volunteers
- 30 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
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
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Feasibility Study of a Percutaneous Mitral Valve Repair System.
Prospective, multi-center, Phase I study of the Evalve Cardiovascular Valve Repair System (CVRS) in the treatment of mitral valve regurgitation. Patients will undergo 30-day, 6 month, 12 month, and 5 year clinical follow-up.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVEREST(I) (NCT00209339)
- Testing
- Percutaneous mitral valve repair (MitraClip Implant)
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- Abbott Medical Devices
Thoracic Aortic Aneurysms
Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE)
The purpose of this study is to evaluate the long-term safety and effectiveness of the Talent Thoracic Stent Graft System for treatment of descending thoracic aneurysms (DTA)following U.S. market approval.
- Trial name
- THRIVE (NCT00805948)
- Testing
- Talent Thoracic Stent Graft System
- Where
- 26 sites in United States
- Volunteers
- 349 people
- Sponsor
- Medtronic Cardiovascular
Abdominal Aortic Aneurysm
Suprarenal Proximal Cuff Study for Treatment of Abdominal Aortic Aneurysm
The use of a suprarenal extension device during the index AAA procedure to accommodate the patient's anatomy and to prevent or repair leakage.
- Trial name
- NCT00739401
- Testing
- Suprarenal Proximal Cuff Extension
- Where
- 8 sites in United States
- Volunteers
- 44 people
- Sponsor
- Endologix
Thoracic Aortic Aneurysms
Safety and Efficacy of Valiant Mona LSA Stent Graft System
The Valiant Mona LSA thoracic stent graft system is for the endovascular repair of aneurysms of the descending thoracic aorta (DTA) in patients who require coverage of the left subclavian artery (LSA).The study is intended to…
- Trial name
- NCT01839695
- Testing
- Valiant Mona LSA Stent Graft System
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 9 people
- Sponsor
- Medtronic Cardiovascular
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
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
Mitral Valve Insufficiency, Mitral Valve Regurgitation
Pivotal Study of a Percutaneous Mitral Valve Repair System
EVEREST II Randomized Controlled Trial (RCT) is a prospective, multi-center, randomized study of the MitraClip® System in the treatment of mitral valve regurgitation, randomizing patients to MitraClip or mitral valve surgery.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- EVERESTIIRCT (NCT00209274)
- Testing
- Percutaneous mitral valve repair using MitraClip implant, Mitral valve repair or replacement surgery
- Where
- United States
- Volunteers
- 279 people
- Sponsor
- Abbott Medical Devices
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
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 Aneurysm
Safety and Effectiveness Trial of the Ventana Fenestrated Stent Graft System
The purpose of this trial is to determine if the Ventana Fenestrated Stent Graft System is safe and effective for the endovascular repair of juxtarenal or pararenal aortic aneurysms.
- Trial name
- NCT01491945
- Testing
- Ventana Fenestrated Stent Graft System
- Where
- 22 sites in United States
- Volunteers
- 76 people
- Sponsor
- Endologix
Abdominal Aortic Aneurysms
A Multicenter, Open Label, Prospective, Non-Randomized Study Of INCRAFT™ In Subjects With AAA (INNOVATION)
This study is a multi-center prospective, open label, non-randomized investigation of INCRAFT™ in subjects with abdominal aortic aneurysms. The study will enroll up to 60 subjects in up to 7 sites in Germany and Italy.
- Trial name
- INNOVATION (NCT01106391)
- Testing
- Cordis AAA stent graft system "INCRAFT TM"
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Cordis US Corp.