Clinical trials: Aortic Diseases
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
Aneurysm, Aortic Aneurysm
Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (ENDURANT France)
The purpose of this study is to assess the benefits of endovascular repair with Endurant Stent Graft System by documenting overall mortality, complications, the rate of conversion to open surgical repair, and the development and…
- Conditions
- Aneurysm, Aortic Aneurysm, Aortic Aneurysm, Abdominal, Vascular Diseases
- Trial name
- NCT01526811
- Testing
- Endurant Stent graft
- Where
- 20 sites in France
- Volunteers
- 180 people
- Sponsor
- Medtronic Cardiovascular
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
Aortic Stenosis
ACURATE IDE: Safety and Effectiveness Study of ACURATE Valve for Transcatheter Aortic Valve Replacement
To evaluate safety and effectiveness of the ACURATE Transfemoral Aortic Valve System for transcatheter aortic valve replacement (TAVR) in subjects with severe native aortic stenosis who are indicated for TAVR.
- Trial name
- NCT03735667
- Testing
- ACURATE neo2™ Transfemoral TAVR System, Medtronic CoreValve TAVR System, Edwards SAPIEN 3 TAVR System
- Where
- 75 sites in United States, Canada
- Volunteers
- 1,948 people
- Sponsor
- Boston Scientific Corporation
TAAA, AAA - Abdominal Aortic Aneurysm
Data Collection of the TUVA BX and iCover Stent Grafts Implanted During Branched Endovascular Aortic Repair (BEVAR)
The study aims to check whether the TUVA BX and iCover stent grafts are safe and work well when used during a specific type of minimally invasive surgery (BEVAR) to treat complex aortic aneurysms.
- Trial name
- NCT07540507
- Testing
- Endovascular Aortic Repair
- Where
- Netherlands
- Volunteers
- 105 people
- Sponsor
- JOTEC GmbH
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
Hypertrophic Cardiomyopathy
Study Evaluating the Safety, Tolerability and Preliminary Pharmacokinetics and Pharmacodynamics of MYK-461
The purpose of this study is to establish initial safety, tolerability, pharmacokinetics and pharmacodynamics of MYK-461 in human subjects.
- Trial name
- NCT02329184
- Testing
- MYK-461
- Where
- 7 sites in United States
- Volunteers
- 15 people
- Sponsor
- MyoKardia, Inc.
Aortic Stenosis, Valvular Cardiomyopathy
Feasibility of 3D Printed Models of Aortic Stenosis in Guiding TAVI Procedure
The aim of 3DP-FAST study is to analyze the accuracy of replicating cardiovascular anatomical structures using different techniques and to evaluate the feasibility of 3D printed models of aortic stenosis in guiding TAVI…
- Conditions
- Aortic Stenosis, Valvular Cardiomyopathy, Aortic Valve Disease
- Trial name
- 3DP-FAST (NCT05484713)
- Testing
- Cardiac imaging, 3D printing of the aortic valve
- Where
- Romania
- Volunteers
- 20 people
- Sponsor
- Cardio Med Medical Center
Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, ATP-Binding Cassette Subfamily C Member 6 Deficiency
Natural History Study: ENPP1 Deficiency or the Early-Onset Form of ABCC6 Deficiency
The purpose of this study is to characterize the natural history of ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) Deficiency and the early-onset form of adenosine triphosphate binding cassette transporter subfamily C…
- Conditions
- Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, ATP-Binding Cassette Subfamily C Member 6 Deficiency, Generalized Arterial Calcification of Infancy, Autosomal Recessive Hypophosphatemic Rickets
- Trial name
- NCT07745179
- Where
- 8 sites in United States, France and 2 more
- Volunteers
- 23 people
- Sponsor
- Inozyme Pharma
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
Aortic Valve Stenosis, Aortic Valve Failure
Portico and Navitor India Clinical Trial
The objective of this clinical trial is to collect data on procedural safety and device performance of the Portico and Navitor devices and FlexNav delivery system to treat patients with severe aortic stenosis in the Indian…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Failure, Aortic Insufficiency, Aortic Stenosis
- Trial name
- NCT05171712
- Testing
- Transcatheter Aortic Valve Replacement
- Where
- 6 sites in India
- Volunteers
- 30 people
- Sponsor
- Abbott Medical Devices
Severe Aortic Stenosis, Valve-in-valve Procedures
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic…
- Trial name
- PARADIGM (NCT07194265)
- Testing
- TAVR with DurAVR® THV, TAVR with SAPIEN THV series or the Evolut THV series
- Where
- Denmark
- Volunteers
- 1,650 people
- Sponsor
- Anteris Technologies Ltd.
Aortic Valve Stenosis
VitaFlow™ Transcatheter Aortic Valve System Post-market Study-The LAUNCH Study
The study objective is to evaluate safety and effectiveness/performance of the Microport™ CardioFlow VitaFlow™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis in the real world settings.
- Trial name
- NCT04414865
- Testing
- VitaFlow™ Transcatheter Aortic Valve System
- Where
- 2 sites in China
- Volunteers
- 100 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Thoracic Aortic Dissection
Prospective Study for Aortic Arch Therapy With stENt-graft for Chimney technologY（PATENCY）
A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of Artery Stent Graft System manufactured by Lifetech Scientific (Shenzhen) Co., LTD.
- Trial name
- NCT03767777
- Testing
- Artery Stent Graft System
- Where
- 21 sites in China
- Volunteers
- 150 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Friedreich Ataxia, Cardiomyopathy, Secondary
Study of LX2006 Gene Therapy in Friedreich Ataxia Cardiomyopathy
The purpose of Study LX2006-03, a multicenter, Phase 2, open-label, randomized, controlled study, is to evaluate the efficacy and safety of LX2006 gene therapy in participants with Friedreich ataxia (FA) cardiomyopathy (CM).
- Trial name
- SUNRISE-FA 2 (NCT07721025)
- Testing
- LX2006, Usual Care
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Lexeo Therapeutics
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 Valve Stenosis, Aortic Valve Stenosis With Insufficiency
Perceval S Aortic Heart Valve Study- North America
To demonstrate the safety and effectiveness of the Perceval S heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Stenosis With Insufficiency, Regurgitation, Aortic Valve, Aortic Valve Incompetence
- Trial name
- NCT01810679
- Testing
- Perceval S Aortic Heart Valve
- Where
- 21 sites in United States
- Volunteers
- 355 people
- Sponsor
- Sorin Group USA, Inc.
Aortic Stenosis, Severe
All Women Comparing Self-expanding ALLEGRA Valve to Any Other Balloon-expandable Valve
Study is aimed to demonstrate that the self-expandable Allegra TAVI system provides lower mean gradient assessed by TTE compared to balloon-expandable valve systems in a female patient population with symptomatic severe aortic…
- Trial name
- NCT05989074
- Testing
- ALLEGRA TAVI System TF, Ballon-expandable valve system
- Volunteers
- 130 people
- Sponsor
- Ceric Sàrl