Clinical trials: Coronary Calcification
Coronary Artery Disease
Shockwave Coronary Rx Lithoplasty® Study (Disrupt CAD I)
Prospective, multi-center, single arm study designed to evaluate the safety and performance of the Shockwave Coronary Rx Lithoplasty® System to treat calcified lesions in the coronary arteries for the purpose of enhancing the…
- Trial name
- NCT02650128
- Testing
- Shockwave Coronary Rx Lithoplasty® System
- Where
- 7 sites in Australia, France and 3 more
- Volunteers
- 60 people
- Sponsor
- Shockwave Medical, Inc.
Severe, Symptomatic
The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B
The purpose of this study is to determine the safety and effectiveness of the SAPIEN XT™ THV with the associated delivery system for inoperable patients with severe symptomatic native aortic stenosis.
- Conditions
- Severe, Symptomatic, Calcific Aortic Stenosis
- Trial name
- PARTNERII B (NCT02184442)
- Testing
- TAVR Implantation with SAPIEN XT, TAVR Implantation with SAPIEN
- Where
- 53 sites in United States
- Volunteers
- 560 people
- Sponsor
- Edwards Lifesciences
Coronary Artery Disease
Coronary Flow Reserve Following Orbital Atherectomy
The purpose of the study was to evaluate coronary artery flow reserve (CFR) following successful percutaneous coronary intervention (PCI) treatment of severely calcified coronary lesions by orbital atherectomy and stenting.
- Trial name
- NCT02339545
- Testing
- Coronary Orbital Atherectomy plus Stenting
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Myocardial Infarction
Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO)
This investigational device exemption (IDE) study is to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System with the Shockwave C2+ 2Hz Coronary IVL Catheter to treat de novo…
- Trial name
- NCT05966662
- Testing
- IVL with Shockwave C2+ 2Hz Coronary IVL Catheter
- Where
- 18 sites in United States
- Volunteers
- 145 people
- Sponsor
- Shockwave Medical, Inc.
Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis
DurAVR™ THV EU-EFS
A prospective, non-randomized, single-arm, multi-center study designed to evaluate the safety and feasibility of DurAVR™ THV System in the treatment of subjects with symptomatic severe native aortic stenosis or failed surgical…
- Conditions
- Symptomatic Aortic Stenosis, Severe Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve Failure
- Trial name
- NCT06510855
- Testing
- DurAVR™ THV System
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Anteris Technologies Ltd.
Primary Coronary Artery Calcification
SoniCrackerTM Single-use Intracoronary Shockwave Catheter
This study aims to observe the safety and effectiveness of the SoniCrackerTM single-use intracoronary shockwave catheter in the pretreatment and balloon dilation of primary coronary artery calcification lesions (coronary artery…
- Trial name
- NCT07873736
- Volunteers
- 390 people
- Sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
Coronary Artery Disease
BM Shockwave Devices Clinical Study in Coronary Calcified Lesions
This clinical trial is a prospective, multicenter, single-arm, target-value study to verify the safety and efficacy of BM coronary shockwave devices for the treatment of coronary calcification lesions.
- Trial name
- NCT07010094
- Testing
- BM shockwave devices
- Where
- China
- Volunteers
- 198 people
- Sponsor
- BrosMed Medical Co., Ltd
Transcatheter Aortic Valve Implantation
Investigation of the ALLEGRA THV System With a New Delivery System in Patients With Aortic Stenosis or Failed Surgical Bioprosthesis
The EMPIRE study confirms the technical performance of the new IMPERIA Delivery System and evaluates the safety and efficacy of the entire ALLEGRA THV System.
- Trial name
- EMPIRE (NCT05478161)
- Testing
- (ALLEGRA Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis
- Where
- 11 sites in Germany, Netherlands and 1 more
- Volunteers
- 137 people
- Sponsor
- NVT GmbH
Aortic Valve Stenosis, Aortic Valve Calcification
ACURATE Enhance Post Market Study
The objective of the ACURATE Enhance study is to assess valve frame expansion and hemodynamics in a routine clinical setting when optimized procedural steps for valve implantation are followed.
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Diseases
- Trial name
- NCT06959862
- Testing
- Transcatheter Aortic Valve Implantation/Replacement
- Sponsor
- Boston Scientific Corporation
Transcatheter Aortic Valve Replacement
Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System
This study was designed to preliminary verify the safety and of efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System With accessories in patients with symptomatic, calcified and severe aortic stenosis using…
- Trial name
- NCT05202977
- Testing
- SinocrownTM Transcatheter Aortic Valve Replacement System
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
Coronary Artery Disease
A Clinical Trial to Assess the Elixir Medical LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter
The objective of the PINNACLE I Clinical Study is to assess safety and performance of the LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX) to treat moderately to severely…
- Trial name
- PINNACLE-I (NCT05828173)
- Testing
- LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX)
- Where
- 7 sites in Belgium, Netherlands
- Volunteers
- 60 people
- Sponsor
- Elixir Medical Corporation
Coronary Artery Disease, Hypercholesterolemia
A Trial Assessing the Effectiveness of Evolocumab in Reducing the Plaque Burden in Participants With Subclinical Atheroma
The main aim of this trial is to demonstrate that Evolocumab plus routine lipid management is superior to routine lipid management alone in modifying plaque (non-calcified) volume as measured by Artificial Intelligence-enabled…
- Conditions
- Coronary Artery Disease, Hypercholesterolemia, Atheroma, Atherosclerotic Plaque
- Trial name
- NCT07803679
- Testing
- Evolocumab, Routine Lipid Management, Autoinjector
- Volunteers
- 308 people
- Sponsor
- Amgen
Aortic Valve Calcification, Aortic Valve Stenosis
VALVOSOFT® Pivotal Study
The objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis
- Trial name
- NCT05235568
- Testing
- VALVOSFT intervention
- Where
- 11 sites in France, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- Cardiawave SA
Dwarfism, Pituitary, Turner Syndrome
Bone Mineral Density (BMD) in Adolescents With Growth Hormone Deficiency (GHD)
This study is a multicenter, open-label, postmarketing surveillance study. The substudy will collect information on BMD in adolescents and young adults with GHD or Turner syndrome who are completing GH treatment for statural…
- Trial name
- NCT00097526
- Volunteers
- 125 people
- Sponsor
- Genentech, Inc.
Transcatheter Aortic Valve Replacement, Severe Symptomatic Calcified Native Aortic Valve Stenosis
Sentinel(TM) Post-Market Registry
The SENTINEL Post-Market Registry is a prospective, multi-center, registry using the CE-Marked Sentinel System in subjects with severe symptomatic calcified native aortic valve stenosis indicated for TAVR.
- Trial name
- NCT02255851
- Testing
- SENTINEL (Cerebral Protection System)
- Volunteers
- 300 people
- Sponsor
- Claret Medical
Coronary Artery Disease, Coronary Artery Calcification
Modification of Coronary Calcium With Laser Based Intravascular Lithotripsy for Coronary Artery Disease (FRACTURE)
The FRACTURE Trial is a prospective, non-randomized, single-arm, multicenter, interventional study in US and international centers.
- Trial name
- FRACTURE (NCT06181240)
- Testing
- Intravascular lithotripsy
- Where
- 46 sites in United States, Belgium and 5 more
- Volunteers
- 426 people
- Sponsor
- Bolt Medical
Coronary Artery Disease, Calcification
Post-Marketing Clinical Study of High-Pressure Cutting Balloon
This study is designed as a prospective, multicenter, 1:1 randomized controlled trial. It plans to enroll 280 patients with moderate-to-severe calcified coronary lesions who are candidates for IVUS-guided DES implantation.
- Trial name
- NCT07835178
- Testing
- High pressure cutting balloon, Non-cutting balloon
- Where
- China
- Volunteers
- 280 people
- Sponsor
- BrosMed Medical Co., Ltd
Aortic Valve Stenosis, Aortic Valve Calcification
REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve SystEm
This is a prospective, single-arm feasibility study designed to assess the acute safety and performance of the Lotus Valve System for transcatheter aortic valve replacement in symptomatic patients with calcified aortic valve…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Valve Disease
- Trial name
- REPRISE I (NCT01383720)
- Testing
- Lotus Valve System
- Where
- 3 sites in Australia
- Volunteers
- 11 people
- Sponsor
- Boston Scientific Corporation
Aortic Valve Stenosis
ExCEED: CENTERA THV System in Intermediate Risk Patients Who Have Symptomatic, Severe, Calcific, Aortic Stenosis
This study will monitor the safety and valve performance of the Edwards CENTERA Transcatheter Heart Valve (THV) System in patients with symptomatic, severe, calcific aortic stenosis who are at intermediate operative risk for…
- Trial name
- NCT03517436
- Testing
- TAVR with CENTERA THV
- Where
- 23 sites in United States
- Volunteers
- 101 people
- Sponsor
- Edwards Lifesciences
Coronary Artery Disease
Evaluate the Safety and Efficacy of OAS in Treating Severely Calcified Coronary Lesions
This is a prospective, single-arm, multi-center study to evaluate the safety and performance of the OAS in treating de novo, severely calcified coronary lesions in adult subjects.
- Trial name
- ORBIT II (NCT01092416)
- Testing
- Diamondback 360 Orbital Atherectomy System
- Where
- 51 sites in United States
- Volunteers
- 443 people
- Sponsor
- Abbott Medical Devices