Clinical trials: Calcific Coronary Arteriosclerosis
Cardiovascular Diseases, Arteriosclerosis
Registry of Coronary Lithotripsy in Spain.
The REPLICA TRIAL tries to assess the intracoronary lithotripsy safety and efficacy profiles in real-world patients with calcified coronary artery disease.
- Conditions
- Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases
- Trial name
- REPLICA (NCT04298307)
- Testing
- Intracoronary lithotripsy (ICL)
- Where
- 26 sites in Spain
- Volunteers
- 426 people
- Sponsor
- Fundación EPIC
Cardiovascular Diseases, Atherosclerosis
The AI-CAC Model for Subclinical Atherosclerosis Detection on Chest X-ray
The AI-CAC model is an artificial intelligence system capable of assessing the presence of subclinical atherosclerosis on a simple chest radiograph.
- Conditions
- Cardiovascular Diseases, Atherosclerosis, Coronary Artery Calcification
- Trial name
- AI-CAC-PVS (NCT06301009)
- Testing
- AI-CAC score
- Volunteers
- 500 people
- Sponsor
- A.O.U. Città della Salute e della Scienza
Cardiovascular Diseases
ASpirin Use and stAtin Strategy for Primary Prevention in Severe Coronary Calcium Score on Computed Tomography
The primary objective of the ASA-3C trial is to evaluate the role of aspirin and high-intensity statin therapy, respectively, in individuals with severe coronary calcification (coronary calcium score ≥300) to prevent…
- Trial name
- ASA-3C (NCT06676280)
- Testing
- Aspirin, High-intensity statin, Guideline-directed statin therapy
- Where
- 32 sites in South Korea
- Volunteers
- 5,000 people
- Sponsor
- Jung-min Ahn
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, Severe Coronary Artery Disease
Lithotripsy Versus Balloon Angioplasty for Optimal Treatment of CAlcified Lesions With and Without Optical Coherence Tomography evaluatION
Severely calcified coronary artery disease means that calcium has built up in the blood vessels that supply the heart. This makes coronary procedures more difficult and increases the risk of complications during and after…
- Conditions
- Coronary Artery Disease, Severe Coronary Artery Disease, Coronary Artery Calcification
- Trial name
- LOCATION (NCT07388030)
- Testing
- IVL Pretreatment + OCT-Guided Stent Implantation, IVL Pretreatment + Angiography-Guided Stent Implantation, Balloon Angioplasty (BA) Pretreatment + OCT-Guided Stent Implantation
- Where
- China
- Volunteers
- 3,060 people
- Sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
Coronary Artery Calcification, Coronary Artery Disease
MAP-Calcification: MicroRNAs as Potential Biomarkers for Coronary Artery Calcification
Coronary artery disease (CAD) remains the leading cause of mortality in the UK with an estimated 80,000 fatalities in 2010. Coronary artery calcification (CAC) is associated with atherosclerotic plaque burden and cardiovascular…
- Conditions
- Coronary Artery Calcification, Coronary Artery Disease, Osteoporosis, Osteopenia
- Trial name
- NCT01992848
- Testing
- Venous blood sampling, 4-day food diary, 1 week UV dosimeter
- Where
- 2 sites in United Kingdom
- Volunteers
- 45 people
- Sponsor
- University of Surrey
Coronary Arterial Disease (CAD)
AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease
A prospective, open-label, multi-site, FIH with up to fifteen (n=15) patients to assess the safety and preliminary effectiveness of the AVS Pulse Intravascular Lithotripsy™ System (Pulse IVL™ System) when used for the treatment…
- Trial name
- POWER CAD I (NCT07510438)
- Testing
- Pulse Intravascular Lithotripsy (Pulse IVL)
- Where
- 3 sites in Australia, New Zealand
- Volunteers
- 15 people
- Sponsor
- Amplitude Vascular Systems, Inc.
Coronary Artery Disease
Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease
Post-market, prospective, multi-center, single-arm observational study to generate real-world clinical evidence associated with coronary IVL in a population of female subjects with calcified coronary artery disease.
- Trial name
- EMPOWER CAD (NCT05755711)
- Testing
- Shockwave Medical Coronary IVL System
- Where
- 49 sites in United States, France and 3 more
- Volunteers
- 399 people
- Sponsor
- Shockwave Medical, Inc.
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.
Coronary Atherosclerosis Due to Severely Calcified Coronary Lesion
The Comparison of Strategies to PREPARE Severely CALCified Coronary Lesions Trial (PREPARE-CALC)
The primary objective of this study is to evaluate the success of lesion preparation with either rotational atherectomy or cutting/scoring balloons as well as the long term effects of a hybrid sirolimus-eluting stent in an…
- Trial name
- PREPARE-CALC (NCT02502851)
- Testing
- Rotational Atherectomy, Cutting/Scoring Balloon
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Segeberger Kliniken GmbH
Solid Carcinoma, 5-Fluorouracil Toxicity
Prevention of Chest Pain in Chemo-treated Cancer Patients
This is a prospective, exploratory, randomised clinical trial. Patients with diagnosed cancer that are to be treated with 5-fluorouracil (5-FU) will be randomised into standard oncological treatment or a cardiological assessment…
- Conditions
- Solid Carcinoma, 5-Fluorouracil Toxicity, Cardiotoxicity, Chemotherapeutic Toxicity
- Trial name
- CATCH (NCT03486340)
- Testing
- Cardiologic assessment
- Where
- Denmark
- Volunteers
- 218 people
- Sponsor
- Vejle Hospital
Coronary Artery Disease
The DANish COronary DEcalcification (DANCODE) Trial
1. Abstract Introduction Coronary artery calcification (CAC) and especially progression in CAC is a strong predictor of acute myocardial infarction and cardiovascular mortality.
- Trial name
- DANCODE (NCT05500443)
- Testing
- Vitamin K2 (Menaquinone-7)
- Where
- 3 sites in Denmark
- Volunteers
- 400 people
- Sponsor
- Odense University Hospital
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
Coronary Artery Disease
PREPARE-CALC-COMBO: Severely Calcified Coronary Lesions Prepared With Rotational Atherectomy and Modified Balloons
A prospective single-arm trial of rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions.
- Trial name
- NCT04014595
- Testing
- Rotational atherectomy in combination with cutting balloon
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- Segeberger Kliniken GmbH
Coronary Disease
The GISE (Società Italiana di Cardiologia Interventistica) - ShockCalcium Registry
The GISE-SHOCKCALCIUM Registry is an Investigator Driven Italian All Comers prospective, observational, multicenter Italian IVL registry of Calcified lesions Treated with Intravascular Lithotripsy.
- Trial name
- NCT05455515
- Testing
- IVL procedures
- Where
- Italy
- Volunteers
- 2,000 people
- Sponsor
- Fondazione GISE Onlus
Coronary Artery Disease, Chronic Renal Failure
Coronary Rotational Atherectomy Elective vs. Bailout in Severely Calcified Lesions and Chronic Renal Failure
The current role of the rotational atherectomy is for non-dilatable coronary lesions and for severely calcified lesions that may interfere with optimal stent expansion.
- Trial name
- CRATER (NCT05353946)
- Testing
- Percutaneous coronary intervention (PCI)
- Where
- Spain
- Volunteers
- 124 people
- Sponsor
- Guillermo Galeote; MD, PhD
Calcific Coronary Arteriosclerosis, Coronary Stenosis
Whole Blood Transcriptomic Signal According to Coronary Atherosclerotic Plaque Burden Assessed by CT Angiography
The present clinical study aims to identify transcriptomic patterns derived from whole blood samples related to coronary atherotic burden.
- Conditions
- Calcific Coronary Arteriosclerosis, Coronary Stenosis, Coronary Plaque, Aortic Calcification
- Trial name
- CORPLAQ-TRAIT (NCT06194526)
- Where
- 2 sites in Argentina
- Volunteers
- 200 people
- Sponsor
- MultiplAI Health Limited
Coronary Artery Calcification, Calcific Coronary Arteriosclerosis
ClinicAL outComes of IntraVascular Lithotripsy Combined With Conventional Lesion Preparation in Patients With Moderate to Severe Coronary Artery Calcification
The goal of this clinical trial is to investigate whether the clinical outcomes of combined application of intravascular lithotripsy (IVL) following routine preconditioning are superior to those of routine preconditioning alone…
- Trial name
- CALC-IVL (NCT07340294)
- Testing
- Intensive Preconditioning Group, Routine preconditioning strategy
- Where
- 4 sites in China
- Volunteers
- 1,096 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)
A Randomized Study of Cutting Balloon Catheter for CAD
This study is designed as a prospective, multi-center, non-inferiority and randomized controlled clinical trial. A total of 158 eligible subjects from 18 sites across the country is planned to be enrolled, and they will be…
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention (PCI), Calcified Coronary Lesions
- Trial name
- NCT07140822
- Testing
- Coronary Cutting Balloon Catheter, VesscideTM Cutting Balloon System
- Where
- China
- Volunteers
- 166 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
Coronary Artery Disease, Intravascular Lithotripsy
Evaluate the Safety and Efficacy of Intracoronary Lithotripsy Balloon Catheter and Intracoronary Lithotripsy Apparatus
This is a prospective, multi-center, single-group target value clinical trial, which will be carried out in many clinical trial institutions in China.
- Trial name
- NCT05649488
- Testing
- Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus, Dragonfly Opstar Imaging Catheter
- Where
- 20 sites in China
- Volunteers
- 184 people
- Sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.