Clinical trials: Endovascular Repair
Endovascular Repair of Infrarenal Abdominal Aortic Aneurysm Using Endovascular Stent Graft
Post-market European & Asian Registry to Evaluate the Minos™ Stent-Graft and Delivery System in Abdominal Aortic Aneurysm Treatment
The Minos™ Abdominal Aortic Stent-Graft and Delivery System is a medical device designed to treat abdominal aortic aneurysms using a minimally invasive procedure.
- Trial name
- PEARL (NCT07674173)
- Testing
- Implantation with Minos Stent graft
- Where
- 16 sites in China, Germany and 4 more
- Volunteers
- 200 people
- Sponsor
- Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd
AAA Graft Implant for Primary Aneurysm Treatment, AAA Graft Repair to Extend Life of Implant
Evaluation of EndoRefix Endovascular Delivery System and Staple
This study is intended to provide data to verify safe delivery of a staple previously intended for use in open surgical procedures.
- Trial name
- EndoRefix (NCT00668681)
- Testing
- EndoRefix
- Where
- 7 sites in United States
- Sponsor
- Lombard Medical
Abdominal Aortic Aneurysm
Safety and Efficacy of the SETA LATECBA Stent Graft for EVAR in Subjects With AAA
This is a Prospective, Open-label, Multicenter, and Non-randomized Clinical Study. The main purpose of this study is to establish the efficacy and safety of a medical device system, SETA LATECBA Stent Graft, intended for the…
- Trial name
- NCT04220177
- Testing
- SETA LATECBA Stent Grafts
- Where
- Canada
- Volunteers
- 42 people
- Sponsor
- Latecba S.A.
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
Abdominal Aortic Aneurysm
Nellix Registry Study: EVAS-Global
Multicenter, single arm, open label, registry study with consecutive, eligible patient enrollment at each site. All subjects undergoing the Endovascular Aneurysm Sealing System (EVAS) with the Nellix®-System.
- Trial name
- EVAS FORWARD 2 (NCT02996396)
- Testing
- Nellix Endovascular Aneurysm Sealing System (Nellix®-System)
- Where
- 10 sites in Germany, Netherlands and 2 more
- Volunteers
- 48 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
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.
Subarachnoid Hemorrhage, Ruptured Intracranial Aneurysm
Safety and Efficacy Study of a Single Dose of NA-1 in Patients Undergoing Endovascular Repair of Ruptured Aneurysms
This is a randomized, double-blind, placebo-controlled, single-dose study investigating the safety and efficacy of NA-1 in patients with subarachnoid hemorrhage (SAH) undergoing endovascular repair of ruptured intracranial…
- Trial name
- ENACT-2 (NCT02056574)
- Testing
- NA-1
- Where
- 12 sites in United States, Canada
- Sponsor
- NoNO Inc.
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.
Vascular Aneurysm
A Study in Patients With Thoracoabdominal Aortic Aneurysm Treated With the E-nside TAAA Multibranch Stent Graft System
The INNER-B post-market clinical follow-up study is undertaken to evaluate the prevention of death related to a thoracoabdominal aneurysm when treated by the E-nside TAAA Multibranch Stent Graft System.
- Trial name
- INNER-B (NCT04383145)
- Testing
- endovascular repair
- Where
- Germany
- Volunteers
- 150 people
- Sponsor
- JOTEC GmbH
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
Chronic Kidney Diseases
A Study to Explore the Renal Safety of Visipaque Injection 320 mgI/mL in Patients With Chronic Kidney Disease
This parallel-group, randomized, placebo-controlled study will examine the incidence and severity of acute kidney injury (AKI) in patients with chronic kidney disease (CKD) stage III/IV following an i.v.
- Trial name
- NCT03119662
- Testing
- Visipaque
- Where
- 29 sites in United States, Belgium and 4 more
- Volunteers
- 4 people
- Sponsor
- GE Healthcare
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
Axium™ MicroFX™ for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study
This is a multicenter, prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 100 aneurysms.
- Trial name
- AMERICA (NCT01323439)
- Testing
- Axium™ MicroFX™ PGLA COILS
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Medtronic Neurovascular Clinical Affairs