Clinical trials: Aortic Aneurysms
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
Abdominal Aortic Aneurysm
LIFE Study: Least Invasive Fast-Track EVAR
The primary objectives of the LIFE Study are to demonstrate the clinical and cost benefits associated with using the Ovation® Abdominal Stent Graft Platform under the least invasive conditions defined in the Fast-Track EVAR…
- Trial name
- NCT02224794
- Testing
- Ovation® Abdominal Stent Graft Platform
- Where
- 2 sites in United States
- Volunteers
- 250 people
- Sponsor
- TriVascular, Inc.
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
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
Aortic Dissection
Zenith® TXD Post-market Surveillance in Japan
The study is a post-market surveillance study required by Japanese Regulatory Authorities as a condition of approval
- Trial name
- NCT02663739
- Testing
- Zenith® TXD
- Where
- 27 sites in Japan
- Volunteers
- 57 people
- Sponsor
- Cook Group Incorporated
Thoracoabdominal Aneurysm
Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of the Thoracoabdominal and Pararenal Aortic Aneurysms (TAMBE)
Expanded access tothe GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis is safe and effective in the treatment of thoracoabdominal and pararenal aneurysms.
- Trial name
- TAMBE (NCT05442489)
- Testing
- GORE Excluder Thoracoabdominal Branch Endoprosthesis
- Where
- 41 sites in United States
- Sponsor
- W.L.Gore & Associates
Aortic Arch Dissection, Aortic Arch Aneurysm
GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Approval Study
A prospective multi-center post-market study collecting outcomes through at least 5-years and up to 10-years post procedure for subjects treated with the TBE Device in Zone 0/1 as part of routine clinical practice.
- Trial name
- NCT07166133
- Testing
- GORE® TAG® Thoracic Branch Endoprosthesis
- Where
- 24 sites in United States
- Volunteers
- 125 people
- Sponsor
- W.L.Gore & Associates
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 (AAA)
The Vascutek Custom Fenestrated Anaconda Post-Market Surveillance Study
This is a multicentre, prospective, observational post-market registry (follow-up 1 month, 1 year, 2 years, 3 years, 4 years and 5 years) to monitor the post-market clinical safety and effectiveness of the Vascutek AnacondaTM…
- Trial name
- NCT01826344
- Where
- 71 sites in Austria, Belgium and 10 more
- Volunteers
- 628 people
- Sponsor
- Vascutek Ltd.
Aortic Aneurysm, Penetrating Ulcer
Zenith® TX2® Low Profile TAA Endovascular Graft
The Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collect confirmatory safety and effectiveness data. The Zenith TX2 Low Profile TAA Endovascular Graft is indicated for the treatment of patients with a…
- Conditions
- Aortic Aneurysm, Penetrating Ulcer, Vascular Disease
- Trial name
- NCT02471781
- Testing
- Zenith TX2 Low Profile TAA Endovascular Graft
- Where
- 15 sites in United States
- Sponsor
- Cook Group Incorporated
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.
Abdominal Aortic Aneurysm
A Multicenter, Open Label, Prospective, Non-randomized Study of the InCraft® Stent Graft System in Subjects With Abdominal Aortic Aneurysms (INSPIRATION)
The purpose of this study is to evaluate the safety and effectiveness of InCraft® in subjects with abdominal aortic aneurysms requiring endovascular repair.
- Trial name
- INSPIRATION (NCT01664078)
- Testing
- Endovascular AAA repair with InCraft®
- Where
- 2 sites in United States, Japan
- Volunteers
- 190 people
- Sponsor
- Cordis US Corp.
Acute Aortic Dissection, Aortic Rupture
Thoraflex Hybrid Post-Market Study
This is a global, prospective non-interventional, multi-centre, post-market study of the Vascutek Thoraflex™ Hybrid system in patients with acute thoracic aortic syndrome, subacute/chronic dissection of the aorta and aortic…
- Conditions
- Acute Aortic Dissection, Aortic Rupture, Penetrating Aortic Ulcer, Aortic Dissection
- Trial name
- THOR (NCT03414866)
- Testing
- EQ-5D-5L QOL questionnaire
- Where
- 7 sites in Canada, Germany and 2 more
- Volunteers
- 182 people
- Sponsor
- Vascutek Ltd.
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.
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 Diseases, Aortic Aneurysm
Thoraflex Hybrid and Relay Extension Post-Approval Study
The goal of this observational study is to evaluate the Thoraflex Hybrid device alone and in combination with the RelayPro NBS stent-graft in the treatment of aortic disease affecting the aortic arch and descending aorta with or…
- Conditions
- Thoracic Diseases, Aortic Aneurysm, Aortic Dissection, Thoracic Aortic Aneurysm
- Trial name
- EXTEND (NCT05639400)
- Testing
- Thoraflex Hybrid, RelayPro NBS
- Where
- 27 sites in United States, Austria and 5 more
- Volunteers
- 352 people
- Sponsor
- Vascutek Ltd.
Abdominal Aortic Aneurysms
Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System
To demonstrate safety and effectiveness of the Endurant Stent Graft in the treatment of Abdominal Aortic or Aorto-Uni-Iliac Aneurysms.
- Trial name
- NCT00705718
- Testing
- Endurant Stent Graft System
- Where
- 30 sites in United States
- Volunteers
- 194 people
- Sponsor
- Medtronic Cardiovascular
Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracoabdominal
Evaluation of the Bifurcated Multilayer Flow Modulator for the Treatment of Abdominal Aortic Aneurysm
The study purpose is to determine the safety and efficacy of the BMFM used for the endovascular treatment of aortic aneurysm involving iliac arteries.
- Trial name
- STREAMLINER (NCT03024554)
- Testing
- Implantation of the Bifurcated Multilayer Flow Modulator
- Where
- 7 sites in Belgium, Bulgaria and 3 more
- Volunteers
- 42 people
- Sponsor
- Cardiatis
Abdominal Aortic Aneurysm
TriVascular European Union (EU) Abdominal Stent Graft Trial
A Clinical Study to Evaluate the Safety and Performance of the TriVascular Ovation Abdominal Stent Graft System
- Trial name
- NCT01097772
- Testing
- Implant of Ovation Abdominal Stent Graft System
- Where
- 7 sites in Germany
- Volunteers
- 30 people
- Sponsor
- TriVascular, 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.