Clinical trials: Aorta Disease
Aortic Aneurysm, Thoracic, Descending Thoracic Aortic Dissection
GORE® TAG® Thoracic Endoprosthesis French Mandatory Registry
This is a French Registry mandated by the French National Health Authority assessing long-term (5-years) safety of the GORE® TAG® Thoracic Endoprosthesis treating diseases of the thoracic aorta.
- Conditions
- Aortic Aneurysm, Thoracic, Descending Thoracic Aortic Dissection, Aortic Diseases, Aorta Thoracic; Traumatic Rupture
- Trial name
- NCT02266342
- Testing
- GORE® TAG® Thoracic Endoprostheses
- Where
- France
- Volunteers
- 154 people
- Sponsor
- W.L.Gore & Associates
Paravalvular Leak
A Multicenter, International, Prospective and Retrospective, Follow-up Registry to Monitor the Efficacy and Safety of the Occlutech Paravalvular Leak Device (PLD) in Patients With Mitral or Aortic Paravalvular Leaks
This is an international, multicenter, retrospective and prospective post-marketing follow-up registry designed to monitor the safety and efficacy of the Occlutech Paravalvular Leak Device (PLD) in patients with clinically…
- Trial name
- PLD REGISTRY (NCT07037446)
- Testing
- Transcatheter paravalvular leak closure device
- Where
- 22 sites in France, Germany and 4 more
- Volunteers
- 200 people
- Sponsor
- Occlutech International AB
Thoracic Aortic Aneurysm, Penetrating Ulcers
Phase II Clinical Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
This study is a continuation of the pivotal trial studying the safety and efficacy of the Relay thoracic stent-graft system to treat thoracic aortic aneurysms.
- Trial name
- NCT01327742
- Testing
- Relay Thoracic Stent-Graft
- Where
- 15 sites in United States
- Sponsor
- Bolton Medical
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
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
The Boston Scientific ENOVUS Trial
A prospective, actively controlled, consecutively enrolling, non-randomized multi center clinical evaluation of the safety and efficacy of the Boston Scientific ENOVUS AAA Endograft when used in the treatment of patients with AAA…
- Trial name
- NCT00246038
- Testing
- Boston Scientific ENOVUS AAA Endograft
- Sponsor
- Boston Scientific Corporation
Heart Diseases, Aortic Stenosis, Severe
EARLY TAVR: Evaluation of TAVR Compared to Surveillance for Patients With Asymptomatic Severe Aortic Stenosis
This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance (CS) in asymptomatic patients with severe, calcific aortic stenosis.
- Trial name
- EARLY TAVR (NCT03042104)
- Testing
- Edwards SAPIEN 3 / SAPIEN 3 Ultra THV
- Where
- 77 sites in United States, Canada
- Volunteers
- 901 people
- Sponsor
- Edwards Lifesciences
Aortic Regurgitation, Aortic Valve Insufficiency
The JenaValve ALIGN-AR Pivotal Trial
To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart.
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
- Trial name
- ALIGN-AR (NCT04415047)
- Testing
- JenaValve Trilogy Heart Valve System
- Where
- 30 sites in United States
- Volunteers
- 180 people
- Sponsor
- JenaValve Technology, Inc.
Aortic Valve Disease, Aortic Valve Stenosis
Safety and Efficacy Study of MicroPort's Transcatheter Aortic Valve and Delivery System for TAVI
The objective of this study is to evaluate the safety and effectiveness of the MicroPort's Valve and delivery system for transcatheter aortic valve implantation (TAVI) in severe aortic stenosis who are considered unsuitable for…
- Conditions
- Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Calcification
- Trial name
- NCT02221921
- Testing
- MicroPort's Transcatheter Aortic Valve and Delivery System
- Where
- China
- Volunteers
- 89 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Aortic Stenosis
DEFLECT I: Keystone Heart Embolic Deflection Trial
This is a research study using the Keystone Heart Embolic Deflection Device and involving patients with aortic stenosis (a disease of the aortic valve), to be treated with Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT01448421
- Testing
- Keystone Heart Embolic Deflection Device
- Volunteers
- 37 people
- Sponsor
- Keystone Heart
Aortic Regurgitation
THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study
To collect information about treatment for severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some…
- Trial name
- NCT02732704
- Testing
- JenaValve Pericardial TAVR System
- Where
- 19 sites in United States, Germany and 1 more
- Volunteers
- 100 people
- Sponsor
- JenaValve Technology, Inc.
Aortic Valve Stenosis
A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System
The purpose of this postmarket Registry is to assess the standard of care and clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System used in clinical routine according to the approved commercial…
- Trial name
- DISCOVER (NCT01845285)
- Testing
- Aortic Valve Replacement
- Where
- 2 sites in Germany, Italy
- Volunteers
- 1,000 people
- Sponsor
- Direct Flow Medical, Inc.
Aortic Stenosis
PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis
To establish the safety and effectiveness of the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) in patients with severe, calcific aortic stenosis who are at low operative risk for standard aortic valve replacement.
- Trial name
- P3 (NCT02675114)
- Testing
- SAVR, SAPIEN 3 THV
- Where
- 77 sites in United States, Australia and 3 more
- Volunteers
- 1,000 people
- Sponsor
- Edwards Lifesciences
Hypertrophic Cardiomyopathy
A Study to Assess Health-Related Quality of Life in Patients With Hypertrophic Cardiomyopathy in Japan
This cross-sectional, non-interventional study will assess health-related quality of life in in patients with hypertrophic cardiomyopathy in Japan. The study consists of two phases.
- Trial name
- NCT06181617
- Testing
- Quality of life assessment
- Where
- Japan
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Abdominal Aortic Aneurysms
Prospective Aneurysm Trial: High Angle Aorfix™ Bifurcated Stent Graft
Purpose of this study: The purpose of the study is to evaluate the safety and effectiveness of the Lombard Medical endovascular Aorfix™ AAA bifurcated stent graft in the treatment of abdominal aortic, aorto-iliac and common iliac…
- Trial name
- PYTHAGORAS (NCT00522535)
- Testing
- Open surgical repair, Stent Graft
- Where
- 38 sites in United States
- Volunteers
- 230 people
- Sponsor
- Lombard Medical
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 Valve Stenosis
Controlled Arterial Protection to Ultimately Remove Embolic Material
The objective of this study is to demonstrate device feasibility, safety and investigate performance of the EmStop Embolic Protection System when used as indicated in 15 subjects at 2 investigational sites in the U.S.
- Trial name
- CAPTURE-1 (NCT06103591)
- Testing
- The EmStop Embolic Protection System (EmStop System)
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- EmStop Inc
Aortic Valve Stenosis
Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Feasibility Trial CANADA
To evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at high risk for aortic valve replacement surgery.
- Trial name
- RADIANT CANADA (NCT02838680)
- Testing
- HLT Transcatheter Aortic Valve System
- Where
- 2 sites in Canada
- Volunteers
- 15 people
- Sponsor
- HLT Inc.
Aneurysm Abdominal, Peripheral Aneurysms
A Retrospective, Observational Study to Collect Clinical Safety and Performance Data of POLYMAILLE® EXTRA THIN Vascular Prothesis
The purpose of this PMCF study is to evaluate a minimum of 125 subjects in 1 or 2 sites in France at least 1-year follow-up after surgery until a maximum of 5 years in the indication of abdominal and peripheral arterial surgery…
- Conditions
- Aneurysm Abdominal, Peripheral Aneurysms, Arterial Disease Occlusive, Prothesis
- Trial name
- NCT05519826
- Testing
- Vascular surgery
- Where
- France
- Volunteers
- 373 people
- Sponsor
- Perouse Medical
Aortic Valve Stenosis
PREVAIL-20J - Transfemoral Placement of 20mm Aortic Balloon Expandable Transcatheter Valve Trial
A single arm, prospective multicenter non-randomized pivotal clinical trial evaluating the 20mm Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX), NovaFlex™ transfemoral delivery system, and crimper accessories.
- Trial name
- PREVAIL-20J (NCT01419015)
- Testing
- SAPIEN XT NovaFlex delivery system
- Where
- 4 sites in Japan
- Volunteers
- 17 people
- Sponsor
- Edwards Lifesciences