Clinical trials: Aneurysm Abdominal
Abdominal Aortic Aneurysm, Aorto-iliac Aneurysm
Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study
A prospective study conducted in Japan to collect confirmatory peri-operative and 30-day information on use of the Zenith LP AAA Graft.
- Conditions
- Abdominal Aortic Aneurysm, Aorto-iliac Aneurysm, Iliac Aneurysm
- Trial name
- ZLP (NCT01326884)
- Testing
- ZLP
- Where
- 2 sites in Japan
- Volunteers
- 27 people
- Sponsor
- Cook Group Incorporated
Abdominal Aortic Aneurysm (AAA), Aorto-iliac Aneurysm
Fenestrated AAA Endovascular Graft Post-Approval Study
This post-market study is approved by the US FDA to evaluate the long-term safety and performance of the Zenith® Fenestrated AAA Endovascular Graft.
- Conditions
- Abdominal Aortic Aneurysm (AAA), Aorto-iliac Aneurysm, Juxtarenal Aneurysm
- Trial name
- NCT01990950
- Testing
- Zenith® Fenestrated AAA Endovascular Graft
- Where
- 6 sites in United States
- Volunteers
- 21 people
- Sponsor
- Cook Research Incorporated
Abdominal Aortic Aneurysm
Cordis Bilateral AAA Device Compared to Open Surgical Repair of Abdominal Aortic Aneurysms (ARIBA)
The objective of this study is to assess the safety and effectiveness of the Cordis Bilateral AAA device and its Delivery System compared to open surgical repair for the treatment of Abdominal Aortic Aneurysm (AAA).
- Trial name
- NCT00235118
- Testing
- Cordis AAA Bilateral Device
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Cordis US Corp.
Abdominal Aortic Aneurysm
Safety and Efficacy Study of Abdominal Aortic Aneurysm Stent Graft System
A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of Abdominal Aortic Aneurysm Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD.
- Trial name
- NCT03687489
- Testing
- Abdominal Aortic Aneurysm Stent Graft System
- Where
- 22 sites in China
- Volunteers
- 156 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Aortic Aneurysm, Abdominal
Suture-Tight™ First-in-Human Safety and Performance Study
Single center, open label, prospective, single-arm, first-in-human (FIH), pre-market clinical study with the objective of validating the safety and performance of the Suture-Tight™ Suture Delivery System in an EVAR procedure.
- Trial name
- Suture-Tight™ (NCT05812768)
- Testing
- Suture-Tight Suture Delivery System
- Where
- Australia
- Volunteers
- 6 people
- Sponsor
- Vesteck, Inc.
Aortic Aneurysm, Abdominal
Aorfix Intelliflex First in Human Study
The First In Human (FIH) study is a long-term, single center, non-randomized study established by Lombard Medical, Inc. to collect "on-label" data in the clinical setting on patients undergoing endovascular repair with…
- Trial name
- FIH-NZ (NCT02907762)
- Testing
- Endovascular aneurysm repair EVAR
- Volunteers
- 10 people
- Sponsor
- Lombard Medical
Abdominal Aortic Aneurysms
The Nellix® EndoVascular Aneurysm Sealing System for the Treatment of Infrarenal Abdominal Aortic Aneurysms
The purpose of this clinical study is to evaluate the safety and device performance of the Nellix® EndoVascular Aneurysm Sealing System (Nellix System) for the treatment of infrarenal abdominal aortic aneurysms.
- Trial name
- NCT02048514
- Testing
- The Nellix® EndoVascular Aneurysm Sealing System
- Where
- 4 sites in Colombia, Latvia and 2 more
- Volunteers
- 69 people
- Sponsor
- Endologix
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
Abdominal Aortic Aneurysm, Endoleak
AneuFix - Prophylactic Sac Filling
This study is set up to assess the feasibility and safety of the clinical procedure using AneuFix in a prophylactic setting at the time of EVAR endograft implantation.
- Trial name
- NCT04307992
- Testing
- Prophylactic sac filling with AneuFix
- Where
- 3 sites in Netherlands
- Volunteers
- 20 people
- Sponsor
- TripleMed B.V.
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 Aneurysm
The Long-Term EVAR Assessment and Follow-Up (LEAF) Study for the AFX2 System
This is an observational, retrospective, multicenter study to evaluate the performance of the AFX2 System using real world evidence from VQI-VISION.
- Trial name
- LEAF (NCT06990048)
- Testing
- AFX2 System
- Where
- United States
- Volunteers
- 2,000 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
Abdominal Aortic Aneurysm
TriVascular Evaluation of Females Who Are Underrepresented Candidates for Abdominal Aortic Aneurysm Repair in Europe
The LUCY Study is a prospective, consecutively enrolling, non-randomized multi center post-market study to evaluate the low profile (14F) Ovation® Abdominal Stent Graft Platform when used in the endovascular treatment of female…
- Trial name
- LUCY (NCT02703428)
- Where
- 10 sites in Belgium, Germany and 2 more
- Volunteers
- 30 people
- Sponsor
- TriVascular, Inc.
AAA - Abdominal Aortic Aneurysm, Aorta Aneurysm
Nectero EAST System Retreatment Study
This is an exploratory pilot study to evaluate the safety and clinical utility of retreatment with an investigational combination product called the Nectero EAST System to treat Abdominal Aortic Aneurysms or AAA.
- Conditions
- AAA - Abdominal Aortic Aneurysm, Aorta Aneurysm, Dilation Aorta
- Trial name
- NCT07505082
- Testing
- Nectero EAST System
- Where
- 2 sites in Australia, New Zealand
- Volunteers
- 10 people
- Sponsor
- Nectero Medical, Inc.
Infrarenal Abdominal Aortic Aneurysm
The Vascutek AnacondaTM Stent Graft System Phase II IDE Study
The Phase I safety study is now complete. FDA approval has been granted to proceed to Phase II. The primary objectives of the Phase II study is to assess the safety and effectiveness of the Anaconda Stent Graft System in subjects…
- Trial name
- NCT00612924
- Testing
- Anaconda Stent Graft System, Anaconda ONE-LOK Stent Graft System
- Where
- 23 sites in United States, Canada
- Volunteers
- 195 people
- Sponsor
- Terumo CVS
Vascular Diseases, Aneurysm
The Study of the Fenestrated Anaconda Device in the Treatment of Abdominal Aortic Aneurysms
The French Ministry registered the Fenestrated Anaconda ™ on the List of Reimbursable Products and Services (LPPR) by the French Health Insurance on February 2018 for a duration of 5 years, while taking up the conditions for…
- Trial name
- EPI-EFA (NCT04592185)
- Testing
- Fenestrated Anaconda™ Device
- Where
- 33 sites in France
- Volunteers
- 106 people
- Sponsor
- Vascutek Ltd.
Thoracoabdominal Aortic Aneurysm, Pararenal Aortic Aneurysm
TAMBE Japan Post-Marketing Surveillance
To evaluate the safety and efficacy of multi component system (TAMBE device) including GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (Aortic Component; AC) under post-marketing use.
- Trial name
- NCT07147569
- Testing
- GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
- Where
- 5 sites in Japan
- Volunteers
- 100 people
- Sponsor
- W.L.Gore & Associates
Aortic Aneurysm, Abdominal
AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion
To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR)…
- Trial name
- NCT06029660
- Testing
- IMPEDE-FX RapidFill Implants, EndoVascular Aneurysm Repair
- Where
- 49 sites in United States, France and 3 more
- Volunteers
- 180 people
- Sponsor
- Shape Memory Medical, Inc.
Abdominal Aortic Aneurysm, Endoleak
ANEUFIX for Endoleak Type II Repair
The study is non-randomized, multicenter international safety, performance and clinical benefit outcome assessment of ANEUFIX to treat patients with isolated type II endoleak in the presence of a growing AAA-sac following an EVAR…
- Trial name
- NCT03918460
- Testing
- ANEUFIX
- Where
- 9 sites in Belgium, Netherlands
- Volunteers
- 40 people
- Sponsor
- TripleMed B.V.
Thoracoabdominal Aortic Aneurysm
GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Type IV Thoracoabdominal Aortic Aneurysms
This study will assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device) in the treatment of Aortic Aneurysms Involving the Visceral Branch Vessels.
- Trial name
- TAMBE (NCT02528500)
- Testing
- GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- W.L.Gore & Associates