Clinical trials: Aortic Diseases
Aortic Valve Stenosis
Assessment of the St Jude Medical Portico Resheathable Aortic Valve System-Alternative Access
Expand the indication of the Portico TF Delivery System and obtain approval of the Alternative Access Delivery System
- Trial name
- Portico ALT (NCT03056573)
- Testing
- Transaortic TAVR Implant, Subclavian /Axillary TAVR implant
- Where
- 10 sites in Denmark, Germany and 3 more
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
Aortic Aneurysm
Validation of a Software and the Follow-up of Anteropoterior Migration of Stent
The treatment of aortic aneurysms is today based on different indicators (diameters, lengths, angles, volumes of the arteries) measured on CT scan images. Several indicators are time consuming and complicatated to measure.
- Trial name
- ASMOT (NCT05287828)
- Testing
- Surgeons CT scan analysis, PRAEVAorta CT scan analysis
- Where
- France
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Nurea
Diseases of Aortic Valve, Aortic Stenosis Disease
Clinical Trial in China for Aortic Valve Stenosis
The purpose of this clinical study is to evaluate the effectiveness and safety of the transcatheter aortic valve system in the treatment of patients with severe aortic stenosis disease who are at high or prohibitive surgical risk.
- Trial name
- NCT05607667
- Testing
- Transcatheter aortic valve replacement
- Where
- 15 sites in China
- Volunteers
- 15 people
- Sponsor
- Genesis Medtech Corporation
Aortic Stenosis
Self-Centering Guide Catheter Feasibility Study
An evaluation of the feasibility of using the Self-Centering Guide Catheter to deliver a guide wire across a stenotic native aortic valve into the left ventricle.
- Trial name
- NCT02639494
- Testing
- Self-Centering Guide Catheter
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Boston Scientific Corporation
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
Heart Valve Diseases
ATS 3f Enable(tm) Aortic Bioprosthesis, Model 6000
This is a prospective, non-randomized, multi-center study designed to evaluate safety and effectiveness of the ATS 3f Enable Aortic Bioprosthesis in a patient population undergoing isolated aortic valve replacement with or…
- Trial name
- Enable (NCT01116024)
- Testing
- ATS 3f Enable Aortic Bioprosthesis Model 6000
- Where
- 10 sites in Austria, Germany and 3 more
- Volunteers
- 173 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
Aortic Aneurysm, Thoracic, Chronic Type B Dissection
Evaluation of the Valiant Mona LSA Thoracic Stent Graft System in Descending TAA and Chronic Dissections
The purpose of the Feasibility study is to characterize the safety of the Valiant Mona LSA Thoracic Stent Graft System, including an assessment of the safety and effectiveness of the device acutely and at the 30 day visit in the…
- Trial name
- NCT02365467
- Testing
- Valiant Mona LSA Thoracic Stent Graft System
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Medtronic Cardiovascular
Aortic Aneurysm, Thoracic
Valiant Evo US Clinical Trial
The purpose of the Valiant Evo US Clinical Trial is to demonstrate the safety and effectiveness of the Valiant Evo Thoracic Stent Graft System in subjects with a descending thoracic aortic aneurysm (DTAA) who are candidates for…
- Trial name
- VEVO (NCT02652949)
- Testing
- Valiant Evo Thoracic Stent Graft System
- Where
- 21 sites in United States
- Volunteers
- 100 people
- Sponsor
- Medtronic Cardiovascular
Heart Valve Disease
On-X Heart Valve - 17mm Aortic and 23mm Mitral
This study examines the hemodynamic and hemolytic properties of two additional smaller size valves to the On-X line of valves already approved by FDA.
- Trial name
- NCT01812174
- Testing
- 17mm aortic valve (On-X ), 23mm mitral valve (On-X)
- Where
- 10 sites in United States, Puerto Rico and 1 more
- Volunteers
- 20 people
- Sponsor
- On-X Life Technologies, Inc.
Abdominal Aortic Aneurysms
ViTAA Registry Pre- and Post-Operative Monitoring for Endovascular Aortic Aneurysm Repair and Serial Monitoring for AAA
This is a Prospective Registry study to collect imaging and clinical data both on patients with aortic aneurysm disease undergoing serial monitoring and on patients pre and post-endovascular repair, using ViTAA (The Sponsor)…
- Trial name
- NCT05004051
- Testing
- ViTAA Analysis
- Where
- 8 sites in United States, Canada
- Volunteers
- 200 people
- Sponsor
- ViTAA Medical Solutions
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
Abdominal Aortic Aneurysms, Iliac Aneurysms
Zenith® Low Profile AAA Endovascular Graft
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in conjunction with the Zenith® Spiral-Z® AAA Iliac…
- Conditions
- Abdominal Aortic Aneurysms, Iliac Aneurysms, Aortoiliac Aneurysms
- Trial name
- NCT02535065
- Testing
- Zenith Low Profile AAA Endovascular Graft and ancillary components
- Where
- 37 sites in United States, Canada
- Volunteers
- 62 people
- Sponsor
- Cook Research Incorporated
Abdominal Aortic Aneurysm, Aorto-iliac Aneurysm
Zenith® LP Abdominal Aortic Aneurysm (AAA) Post-Market Registry
A registry to collect additional prospective intra-operative and follow-up information on physician use of the CE-marked Zenith® Low Profile Abdominal Aortic Aneurysm (AAA) Endovascular Graft under routine clinical care.
- Trial name
- NCT01424267
- Testing
- Zenith® Low Profile AAA Endovascular Graft
- Where
- 15 sites in Austria, Germany and 5 more
- Volunteers
- 76 people
- Sponsor
- Cook Group Incorporated
Aortic Valve Stenosis
RESPOND Post Market Study
The purpose of the RESPOND post market study is to collect real world clinical and device performance outcomes data with the Lotus Valve System used in routine clinical practice to demonstrate that the commercially available…
- Trial name
- RESPOND (NCT02031302)
- Testing
- Lotus Valve System
- Where
- 41 sites in Colombia, Finland and 11 more
- Volunteers
- 1,064 people
- Sponsor
- Boston Scientific Corporation
HOCM, Hypertrophic Obstructive Cardiomyopathy
A Study to Evaluate Mavacamten in Adults With Symptomatic Obstructive HCM Who Are Eligible for Septal Reduction Therapy
This is a randomized, double-blind, placebo-controlled, multi-center study in the United States (U.S.) that will evaluate the effect of mavacamten treatment on reducing the number of septal reduction therapy (SRT) procedures…
- Trial name
- VALOR-HCM (NCT04349072)
- Testing
- Mavacamten
- Where
- 21 sites in United States
- Volunteers
- 112 people
- Sponsor
- Bristol-Myers Squibb
Abdominal Aortic Aneurysm
Abdominal Aortic Aneurysm Sac Healing and Prevention of Endoleaks
To determine the safety and efficacy of IMPEDE-FX Embolization Plug and/or IMPEDE-FX Rapid Fill to fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft.
- Trial name
- AAA-SHAPE (NCT04227054)
- Testing
- IMPEDE-FX Embolization Plug
- Where
- 2 sites in New Zealand
- Volunteers
- 15 people
- Sponsor
- Shape Memory Medical, Inc.
Severe Aortic Stenosis
Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement
The purpose of the study is to evaluate the safety and efficacy of the Medtronic CoreValve® System in the treatment of symptomatic severe aortic stenosis in subjects who have a predicted high risk for aortic valve surgery and/or…
- Trial name
- NCT01240902
- Testing
- Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI), Surgical Aortic Valve Replacement (SAVR)
- Where
- 45 sites in United States
- Volunteers
- 1,453 people
- Sponsor
- Medtronic Cardiovascular
Abdominal Aortic Aneurysm
TriVascular Canadian LIFE Study: Least Invasive Fast-Track EVAR (Endovascular Aneurysm Repair)
The primary objectives of the LIFE Study are to demonstrate the clinical cost and benefits associated with using the Ovation Prime Abdominal Stent Graft System under the least invasive conditions defined in the Fast-Track EVAR…
- Trial name
- NCT02451566
- Testing
- Ovation Prime Abdominal Stent Graft System
- Where
- Canada
- Volunteers
- 20 people
- Sponsor
- TriVascular, Inc.
Aortic Dissection
False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study (FLAGSHIP_CHL)
To determine the safety and feasibility of the investigational product to reduce aortic dissection false lumen perfusion.
- Trial name
- FLAGSHIP_CHL (NCT07387250)
- Testing
- False Lumen Embolization System, IMPEDE-FX RapidFill
- Volunteers
- 15 people
- Sponsor
- Shape Memory Medical, Inc.