Clinical trials: Aneurysm Aortic
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
- 22 sites in United States
- Volunteers
- 125 people
- Sponsor
- W.L.Gore & Associates
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 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.
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.
Cardiac Rhythm Disorders, Urological Disorders
Product Surveillance Registry
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products.
- Conditions
- Cardiac Rhythm Disorders, Urological Disorders, Neurological Disorders, Cardiovascular Disorders
- Trial name
- PSR (NCT01524276)
- Where
- 402 sites in United States, Argentina and 39 more
- Volunteers
- 100,000 people
- Sponsor
- Medtronic
Aortic Arch Aneurysm, Aortic Arch Dissection
Clinical Study to Evaluate the Safety and Effectiveness of Arcevo LSA
The goal of this clinical trial is to learn if the Arcevo LSA stent graft can safely and effectively treat patients that have an acute or chronic aortic dissection and/or aneurysm that involves the aortic arch and the descending…
- Conditions
- Aortic Arch Aneurysm, Aortic Arch Dissection, Chronic Aortic Dissection, Acute Aortic Dissection
- Trial name
- ARTIZEN (NCT07089576)
- Testing
- Arcevo™ LSA Hybrid Stent Graft System
- Where
- 26 sites in United States, Germany and 1 more
- Volunteers
- 132 people
- Sponsor
- Artivion Inc.
Aortic Aneurysm, Abdominal, Juxtarenal Aortic Aneurysm
Zenith® Fenestrated+ Clinical Study
The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent…
- Conditions
- Aortic Aneurysm, Abdominal, Juxtarenal Aortic Aneurysm, Extent IV Thoracoabdominal, Pararenal Aneurysm
- Trial name
- NCT04875429
- Testing
- Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2
- Where
- 33 sites in United States, United Kingdom
- Volunteers
- 105 people
- Sponsor
- Cook Research Incorporated
Thoracic Aortic Aneurysm, Penetrating Aortic Ulcers (PAUs)
MBA Early Feasibility Study
The MBA 25-04 study is a prospective, multicenter, non-randomized, single-arm, early feasibility study designed to assess the initial safety of the MBA device through five years following the index endovascular procedure.
- Conditions
- Thoracic Aortic Aneurysm, Penetrating Aortic Ulcers (PAUs), Thoracic Aortic Dissection, Pseudoaneurysm
- Trial name
- NCT07564375
- Testing
- GORE® Multibranch Arch Endoprosthesis, GORE® Ascending Stent Graft
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- W.L.Gore & Associates
Abdominal Aortic Aneurysm
Nectero EAST System Clinical Study
The purpose of this randomized clinical trial is to treat patients with small to mid-sized abdominal aortic aneurysms (AAA), maximum diameter of 3.5 cm to 5.0 cm, using a locally delivered, single-dose endovascular treatment.
- Trial name
- stAAAble (NCT06001918)
- Testing
- Nectero EAST System
- Where
- 42 sites in United States, Australia and 1 more
- Volunteers
- 400 people
- Sponsor
- Nectero Medical, Inc.
Abdominal Aortic Aneurysm, Thoracic Aortic Aneurysm
Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used as a Bridging Stent With Branched and Fenestrated Endografts in the Treatment of Aortic Aneurysms Involving the Renal-Mesenteric Arteries
Multicenter, single-arm retrospective and prospective registry is being conducted to confirm the clinical performance and safety of GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis when used as a Bridging Stent with Branched…
- Trial name
- EMBRACE (NCT05143138)
- Testing
- GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
- Where
- 14 sites in Denmark, Italy and 4 more
- Volunteers
- 259 people
- Sponsor
- W.L.Gore & Associates
AAA - Abdominal Aortic Aneurysm
Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System China Study(ATHENA)
To evaluate the safety and effectiveness of the Heli-FX EndoAnchor system in AAA subjects who without augmented radial fixation and/or sealing due to an endoleak or migration are at high risk for aneurysm-related complications or…
- Trial name
- ATHENA (NCT07754318)
- Testing
- Heli-FX EndoAnchor System
- Where
- China
- Volunteers
- 142 people
- Sponsor
- Medtronic Cardiovascular
Aortic Aneurysm, Thoracic, Aorta, Lesion
Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 0/1
The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta.
- Trial name
- SSB 11-02 (NCT02777528)
- Testing
- GORE® TAG® Thoracic Branch Endoprosthesis, Revascularization Procedure
- Where
- 39 sites in United States, Japan
- Volunteers
- 79 people
- Sponsor
- W.L.Gore & Associates
Aortic Aneurysm, Thoracic, Aorta; Lesion
Evaluation of the GORE® TBE Device in the Treatment of Lesions of the Aortic Arch and Descending Thoracic Aorta, Zone 2
The objective of this study is to determine whether the GORE® TAG® Thoracic Branch Endoprosthesis is safe and effective in treating lesions of the aortic arch and descending thoracic aorta, requiring Zone 2 proximal implantation…
- Trial name
- SSB 11-02 (NCT02777593)
- Testing
- GORE® TAG® Thoracic Branch Endoprosthesis
- Where
- 35 sites in United States
- Volunteers
- 250 people
- Sponsor
- W.L.Gore & Associates
Heart Failure, Cardiomyopathies
Multimodal Physiologic State Intelligence Study
The OMNIPHYS study will investigate whether multimodal ultrasound and other routinely collected clinical and physiologic data can be combined with artificial intelligence to characterize changes in a person's physiologic state…
- Conditions
- Heart Failure, Cardiomyopathies, Pulmonary Hypertension, Myocarditis; Acute or Subacute
- Trial name
- OMNIPHYS (NCT07814118)
- Testing
- OMNIPHYS Multimodal Ultrasound Imaging System
- Where
- United States
- Volunteers
- 25,000 people, healthy volunteers welcome
- Sponsor
- Truway Health, Inc.
AAA, AAA - Abdominal Aortic Aneurysm
JAGUAR Trial: ObJective Analysis to GaUge EVAR Outcomes Through Randomization
Prospective, randomized, multi-center study designed to evaluate the outcomes of commercially available contemporary EVAR in a real-world population.
- Trial name
- JAGUAR (NCT05064540)
- Testing
- Alto Abdominal Stent Graft System, FDA Approved EVAR AAA Graft Systems
- Where
- 29 sites in United States
- Volunteers
- 450 people
- Sponsor
- Endologix
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
Thoracoabdominal Aortic Aneurysm
Evaluation of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis in the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms
Prospective, non-randomized, , multicenter study with two independent arms: Primary Study Arm - TAAA and Pararenal aneurysms requiring only TAMBE System. Hypothesis-driven analysis.
- Trial name
- TAMBE (NCT03728985)
- Testing
- GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
- Where
- 44 sites in United States, United Kingdom
- Volunteers
- 102 people
- Sponsor
- W.L.Gore & Associates
Aneurysm, Dissection
PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches
The purpose of this registry is to collect safety and performance data on all commercially available Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice.
- Conditions
- Aneurysm, Dissection, Aortic Root Aneurysm, Aortic Root Dissection
- Trial name
- PANTHER (NCT04545502)
- Testing
- Gelsoft Plus Vascular Graft, Vascular Bypass Graft, Cardiovascular Patch
- Where
- 30 sites in United States, Belgium and 4 more
- Volunteers
- 2,000 people
- Sponsor
- Vascutek Ltd.
Vascular Disease, Dissection
Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance
An observational, prospective multi-regional post-market registry collecting mid- and long-term data to assess outcomes through ten years of follow-up for subjects treated with GORE® TAG® Conformable Thoracic Stent Graft with…
- Conditions
- Vascular Disease, Dissection, Dissection Aortic Aneurysm, Dissection of Aorta
- Trial name
- TGR 23-02TA (NCT06658730)
- Testing
- Endovascular
- Where
- 37 sites in United States, Denmark and 8 more
- Volunteers
- 1,500 people
- Sponsor
- W.L.Gore & Associates
Abdominal Aortic Aneurysms (AAA)
A Clinical Investigational Study of Ankura™ II AAA, IE and AE Stent Graft System for Endovascular Treatment of Abdominal Aortic Aneurysm
The objective of this clinical investigational study is to evaluate the safety and efficacy of the Ankura™ II AAA, AE Stent Graft System and the large-size Ankura™ II IE Stent Graft System (i.e., IE stent grafts with distal…
- Trial name
- NCT07754240
- Testing
- Ankura™ II Abdominal Aortic Stent Graft System
- Where
- Bulgaria
- Volunteers
- 45 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.