Clinical trials: Aorta Disease
Aortic Valve Insufficiency
Evaluation of ARi With OpSens SavvyWire
The goal of this observational study is to establish the degree of agreement to Aortic Regurgitation (AR) severity during aortic valve intervention between the Aortic Regurgitation Index (ARi) measured by the Opsens SavvyWire…
- Trial name
- ARi (NCT06295068)
- Testing
- Transcatheter Aortic Valve Replacement (TAVR), Balloon Aortic Valvuloplasty (BAV)
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Opsens, Inc.
Thoracic Aortic Diseases
The Single Branch NEXUS™ Clinical Study
A prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Subjects will be followed-up for five years.
- Trial name
- NexusSB (NCT03208504)
- Testing
- Nexus™ Aortic Arch Stent graft
- Where
- Germany
- Volunteers
- 1 people
- Sponsor
- Endospan Ltd.
Aortic Valve Disease
Trifecta™ Durability Study
The Trifecta™ Durability Study was a multi-center, prospective, single-arm, post-market study conducted in Europe and Canada to collect long-term safety and performance data on the Trifecta™ valve.
- Trial name
- NCT01256710
- Testing
- Trifecta™ aortic bioprosthesis
- Where
- Germany
- Volunteers
- 1,151 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Stenosis, Aortic Valve Calcification
Safety and Performance of TAVI of Venus MedTech Aortic Valve Prosthesis
1. objectives Evaluate the performance of Venus MedTech aortic valve prosthesis intervention by femoral artery Evaluate safety and clinical benefit of percutaneous implantation of the Venue MedTech aortic valve prosthesis.
- Trial name
- Venus-A (NCT01683474)
- Testing
- Venus MedTech Aortic Valve Prosthesis
- Where
- China
- Volunteers
- 80 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
Vascular Diseases
A Post-Market Clinical Follow-up Study in Patients Treated With Vascular Grafts
The FLOWGRAFT post-market clinical follow-up study is undertaken to show the safety and performance of FlowWeave Bioseal, FlowNit Bioseal, FlowLine Bipore and FlowLine Bipore Heparin (combined named as Vascular Grafts) in the…
- Trial name
- FLOWGRAFT (NCT05145517)
- Testing
- Open repair
- Where
- Germany
- Volunteers
- 500 people
- Sponsor
- JOTEC GmbH
Retinal Detachment, Achilles Tendon
A Study of Fluoroquinolones Exposure and Collagen-Related Serious Adverse Events
The purpose of this study is to evaluate whether there is an increased risk of achilles tendon rupture (ATR), retinal detachment (RD) or aortic aneurysm and dissection (AAD) following exposure to fluoroquinolone (FQ) or other…
- Conditions
- Retinal Detachment, Achilles Tendon, Aneurysm, Dissecting
- Trial name
- NCT03479736
- Testing
- Oral Fluoroquinolones (FQ), Other Antibiotics, Febrile Illness Not Treated with Antibiotics Will be Analyzed as an Exposure
- Where
- United States
- Volunteers
- 117,911 people
- Sponsor
- Janssen Research & Development, LLC
Aortic Aneurysm
ANCHOR (Aneurysm Treatment Using the Heli-FX™ EndoAnchor™ System Global Registry)
The ANCHOR registry is a multi-center, post-market, non-interventional, non-randomized, prospective study. Subjects must sign an ICF prior to obtaining any study specific information.
- Trial name
- ANCHOR (NCT01534819)
- Testing
- EndoAnchor™, endovascular treament
- Where
- 87 sites in United States, Australia and 11 more
- Volunteers
- 1,090 people
- Sponsor
- Medtronic Cardiovascular
Aortic Aneurysm, Aortic Dissection
Clinical Investigation of Clinical Safety and Performance of the SP-GRIPFLOW, Selective Cerebral Perfusion Catheter When Used for Cerebral Perfusion During Aortic Arch Repair
The purpose of this study is to determine if the SP-GRIPFLOW catheter (the catheter designed by Fuji Systems) is safe and how well it functions.
- Conditions
- Aortic Aneurysm, Aortic Dissection, Aortic Arch Aneurysm, Aortic Arch; Aneurysm, Dissecting
- Trial name
- NCT05421130
- Testing
- Selective Cerebral Perfusion Catheter
- Where
- 5 sites in Germany, Netherlands
- Volunteers
- 149 people
- Sponsor
- Fuji Systems Corporation
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
Cardiomyopathy, Hypertrophic, Cardiomyopathy, Hypertrophic, Familial
Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
The purpose of this study is to evaluate the effect of perhexiline on exercise performance (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe heart failure following dosing for 16 weeks.
- Trial name
- NCT02862600
- Testing
- Perhexiline, Use of bioanalytical assay to monitor plasma levels of perhexiline
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- Heart Metabolics Limited
Abdominal Aortic Aneurysm
GORE® EXCLUDER® 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® Excluder® Endoprosthesis in the treatment of infra-renal Abdominal Aortic Aneurysms (AAA).
- Trial name
- NCT02308839
- Testing
- GORE® EXCLUDER® Endoprosthesis
- Where
- France
- Volunteers
- 181 people
- Sponsor
- W.L.Gore & Associates
Aortic Stenosis, Aortic Insufficiency
Freedom SOLO Stentless Heart Valve Study
The purpose of this clinical investigation is to demonstrate the safety and effectiveness of the Freedom SOLO heart valve.
- Trial name
- SOLO (NCT01115907)
- Testing
- Freedom SOLO Stentless Heart Valve
- Where
- 15 sites in United States, Canada
- Volunteers
- 251 people
- Sponsor
- Sorin Group USA, Inc.
Aortic Stenosis, Valvular Heart Disease
ADVANCE Direct Aortic Study
This study is intended to collect data regarding the clinical utility, safety and performance of the Medtronic CoreValve® System for Transcatheter Aortic Valve Implantation (TAVI) in patients with severe symptomatic aortic valve…
- Trial name
- NCT01676727
- Testing
- CoreValve aortic valve
- Where
- 9 sites in Czechia, France and 4 more
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracoabdominal
Clinical Application of the Medyria TrackCath System in Endovascular Repair of Abdominal Aortic Aneurysms (AAA)
Pre-market, single-arm, prospective, open-label, multi-center clinical trial aimed at assessing the safety and the performance of the Medyria TrackCath system in patients undergoing endovascular intervention.
- Conditions
- Aortic Aneurysm, Abdominal, Aortic Aneurysm, Thoracoabdominal, Acute Renal Failure, Acute Kidney Injury
- Trial name
- ACCESS (NCT04190979)
- Testing
- Medyria TrackCath System
- Where
- 4 sites in Germany
- Volunteers
- 40 people
- Sponsor
- Medyria AG
Aortic Stenosis, Mitral Stenosis
ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses With a New Tissue Treatment Platform (COMMENCE)
The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their…
- Conditions
- Aortic Stenosis, Mitral Stenosis, Aortic Valve Insufficiency, Mitral Valve Insufficiency
- Trial name
- COMMENCE (NCT01757665)
- Testing
- Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M
- Where
- 32 sites in United States, Canada and 1 more
- Volunteers
- 777 people
- Sponsor
- Edwards Lifesciences
Symptomatic Severe Aortic Stenosis
FlexNav EU CE Mark Study
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic…
- Trial name
- NCT03724812
- Testing
- Portico Valve and FlexNav™ Delivery System
- Where
- 6 sites in Denmark, Italy and 2 more
- Volunteers
- 46 people
- Sponsor
- Abbott Medical Devices
Aortic Aneurysm
Bentley Bridging Stent Graft Study
This international, observational multi-centre observational study of the devices BeFlared FEVAR Stent Graft System (BeFlared), BeGraft Stent Graft System (BeGraft), and BeGraft Plus Stent Graft System (BeGraft Plus) will monitor…
- Trial name
- BeFab (NCT07295145)
- Testing
- endovascular aortic repair (EVAR)
- Volunteers
- 150 people
- Sponsor
- Bentley InnoMed GmbH
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
Hypertension
Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension
The study examined the efficacy of LCZ696 in comparison to the ARB olmesartan on Central Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial stiffness in elderly patients with an elevated…
- Trial name
- NCT01692301
- Testing
- LCZ696, Olmesartan, amlodipine
- Where
- 47 sites in United States, Argentina and 10 more
- Volunteers
- 454 people
- Sponsor
- Novartis Pharmaceuticals
Aortic Aneurysm, Thoracic
GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta
The objective of this study is to assess the safety and efficacy of the 45 mm TAG device in subjects with aneurysms of the descending thoracic aorta.
- Trial name
- NCT00608829
- Testing
- GORE TAG® Thoracic Endoprosthesis
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- W.L.Gore & Associates