Clinical trials: Calcific Coronary Arteriosclerosis, open to volunteers
Coronary Arterial Disease, Calcified Coronary Artery Disease
ShockFast Intravascular Lithotripsy Device for Treatment of Calcified Coronary Lesions
Coronary artery disease is caused by narrowing of the artery lumen. Treatment with Percutaneous Coronary Intervention (PCI) may be needed.
- Trial name
- IVL (NCT07407738)
- Testing
- Shockwave IVL, Shockfast IVL
- Where
- 13 sites in France, Germany and 2 more
- Volunteers
- 120 people
- Sponsor
- Shunmei Medical
Coronary Artery Calcification, Cardiovascular Risk
Artificial Intelligence - Based Opportunistic Coronary Artery Calcium Scoring on Routine Chest-CT Scan
This retrospective, non-interventional study externally validates a pre-trained open-weight deep-learning algorithm (Swin-UNETR) for the opportunistic quantification of coronary artery calcium (CAC) on non-gated routine chest CT…
- Conditions
- Coronary Artery Calcification, Cardiovascular Risk, Coronary Artery Disease, End-Stage Renal Disease Requiring Haemodialysis
- Trial name
- NCT07808593
- Volunteers
- 1,950 people
- Sponsor
- University of Cologne
Coronary Disease, Coronary Artery Disease
The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial
Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation has become the dominant treatment strategy for patients with acute and chronic coronary artery disease (CAD) requiring revascularization.
- Conditions
- Coronary Disease, Coronary Artery Disease, Calcific Coronary Arteriosclerosis, Stent Restenosis
- Trial name
- VICTORY (NCT05346068)
- Testing
- OPN™ NCB Super High Pressure PCI Balloon, Shockwave™ C2 IVL Catheter
- Where
- Switzerland
- Volunteers
- 280 people
- Sponsor
- Luzerner Kantonsspital
Coronary Arterial Disease (CAD), Coronary Calcification
Orbital Atherectomy vs Intravascular Lithotripsy for the Treatment of Calcified Coronary Nodules (ORBIT-SHOCK).
The ORBIT-SHOCK pilot study is a multicenter, prospective, randomized clinical trial initiated by investigators. It will include patients diagnosed with atherosclerotic coronary artery disease presenting calcified nodules (CN)…
- Conditions
- Coronary Arterial Disease (CAD), Coronary Calcification, Coronary Calcified Nodules, Orbital Atherectomy
- Trial name
- ORBIT-SHOCK (NCT06736665)
- Testing
- Orbital atherectomy, Intravascular lithotripsy, Optical Coherence Tomography (OCT)
- Where
- 6 sites in Spain
- Volunteers
- 50 people
- Sponsor
- Spanish Society of Cardiology
Coronary Artery Disease
AI-Based CT Analysis of Coronary Plaque Evolution
This retrospective, multicenter, observational study will evaluate an artificial intelligence-based system for quantitative assessment and risk stratification of coronary atherosclerotic plaque.
- Trial name
- AI-CT-PLAQUE (NCT07886996)
- Where
- 5 sites in China
- Volunteers
- 326 people
- Sponsor
- Zhejiang Hospital
Coronary Arterial Disease (CAD), Calcific Coronary Arteriosclerosis
Evaluation of Calcified Coronary Lesion Preparation With the Naviscore Scoring Balloon
The purpose of this clinical study is to evaluate the effectiveness and safety of a specialized medical device, the Naviscore scoring balloon, in preparing calcified coronary artery narrowings before the implantation of a…
- Trial name
- MILOU (NCT07650578)
- Testing
- Scoring Balloon PTCA Catheter, Non-Compliant (NC) Angioplasty Balloon
- Where
- 14 sites in Belgium, Luxembourg and 2 more
- Volunteers
- 200 people
- Sponsor
- University of Mons
Coronary Artery Calcification, Ischemic Heart Disease
The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation
This is a prospective, single-center, three-arm study to evaluate the impact of severely calcified coronary lesions treatment on microvascular circulation.
- Conditions
- Coronary Artery Calcification, Ischemic Heart Disease, Non-ST-Segment Elevation Myocardial Infarction (NSTEMI), Coronary Artery Disease
- Trial name
- NCT06507449
- Testing
- Lithotripsy, Orbital atherectomy, High-pressure non-compliant balloon
- Where
- Poland
- Volunteers
- 30 people
- Sponsor
- Medical University of Silesia
Coronary Artery Disease (CAD), Calcific Coronary Arteriosclerosis
Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions: the OROBICA Registry.
The OROBICA (Overviewing Real-World Outcomes to Boost Interventional Management of CAlcified Coronary Lesions) Registry is a multicenter, ambispective, real-world observational study designed to evaluate clinical, procedural…
- Conditions
- Coronary Artery Disease (CAD), Calcific Coronary Arteriosclerosis, Intravascular Lithotripsy; Rotational Atherectomy; OFDI, Orbital Atherectomy
- Trial name
- OROBICA (NCT07566403)
- Testing
- Percutaneous coronary intervention with or without stent implantation
- Where
- Italy
- Volunteers
- 3,000 people
- Sponsor
- Papa Giovanni XXIII Hospital
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, 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
Atherosclerotic Cardiovascular Disease (ASCVD), Coronary Artery Calcification
Health Enhanced Artery Risk Tracking With Widespread Implementation and Screening Effort in ASCVD (HEARTWISE-ASCVD)
This multi-site study will test whether an opportunistic AI-based CAC screening and notification intervention can improve cholesterol treatment and lower cholesterol levels in adults.
- Trial name
- HEARTWISE (NCT07355894)
- Testing
- AI-Detected CAC Notification and Care Facilitation
- Where
- 6 sites in United States
- Volunteers
- 120,000 people
- Sponsor
- Stanford University
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
Vascular Calcification
Comparison of RA-IVL and RA-SHP in Calcified Coronary Lesions
Study Design Prospective, multicenter, single-blind, randomized controlled trial Hypothesis In patients with severely calcified coronary lesions undergoing rotational atherectomy (Rota), post-rotational lesion optimization using…
- Trial name
- CRUSH-CALC (NCT07279987)
- Testing
- Super High-Pressure Non-Compliant Balloon, Intravascular Lithotripsy System
- Where
- China
- Volunteers
- 162 people
- Sponsor
- Lin Zhao
Coronary Artery Disease
Influence of Vessel Wall Calcification on Early Stent Strut Healing
To assess the influence of superficial calcium on the early endothelialization (1 month) of the struts of the Xience Skypoint stent (comparing struts with underlying superficial calcium to struts without underlying calcification)
- Trial name
- CaOCT (NCT06631755)
- Testing
- Xience Skypoint stent over calcified coronary lesions
- Where
- Spain
- Volunteers
- 40 people
- Sponsor
- Fundación EPIC
Coronary Disease, Coronary Artery Disease
COMPLEX Registry - a Prospective COhort Study to Describe the Management and Outcomes of Patients Presenting with CompLEX and Calcified Coronary Artery Disease
The purpose of the COMPLEX Registry is to prospectively and retrospectively collect baseline, clinical and procedural data of patients who have undergone PCI or CABG for complex and/ or calcified chronic CAD, irrespective of…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Coronary Arteriosclerosis
- Trial name
- COMPLEX (NCT06075602)
- Testing
- Impact of current PCI techniques/ devices in complex coronary artery lesions
- Where
- Switzerland
- Volunteers
- 5,000 people
- Sponsor
- Luzerner Kantonsspital
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
The Prospective Segeberg Registry for Rotational Atherectomy in Coronary Lesion/s
A Prospective Follow-up Assessment in Bad Segeberg with Patients undergoing a Rotational Atherectomy in Coronary Lesion/s
- Trial name
- NCT04011527
- Testing
- Rotational Atherectomy in Coronary Lesion/s
- Where
- Germany
- Volunteers
- 1,500 people
- Sponsor
- Segeberger Kliniken GmbH
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
This pilot randomized, open-label, outcome blinded clinical trial is to evaluate the preliminary effects of low-dose Colchicine (LoDoCo) on coronary artery calcification (CAC) progression in adults with chronic kidney disease…
- Conditions
- Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function, Vascular Calcification, Coronary Artery Calcification
- Trial name
- RESOLVE-CKD (NCT07654231)
- Testing
- Low-dose Colchicine at 0.5mg daily, Usual Care
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Texas Southwestern Medical Center
Coronary Artery Disease, Calcification
Intravascular Lithotripsy for Acute Stent Under-expansion in Calcified Coronary Lesions
Percutaneous coronary intervention (PCI) is the standard treatment for patients with coronary artery disease who have an indication for surgery.
- Trial name
- NCT06669195
- Testing
- Intravascular lithotripsy group, high-pressure balloon group
- Volunteers
- 40 people
- Sponsor
- Xuzhou Third People's Hospital
Coronary Atherosclerosis Due to Calcified Coronary Lesion
ProActive Athlete Heart Program: Proposal for Cardiac Risk Screening in Former High-Intensity Athletes
AI-Guided Coronary CT Angiography Screening in Former High-Intensity Athletes
- Trial name
- NCT07460583
- Testing
- Coronary CTA
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Baylor Research Institute