Clinical trials: Arterial Calcification
Chronic Limb Threatening Ischemia, Chronic Limb-Threatening Ischemia
ORbital Atherectomy for Lesion Preparation in Patients With Chronic Limb-threatening ischEmia
ORACLE is a Europe-wide study that will follow 250 people with critical limb-threatening ischemia (CLTI). It aims to see how well orbital atherectomy (OA) works in real-life practice.
- Trial name
- ORACLE (NCT07270562)
- Testing
- Stealth 360™ Peripheral Orbital Atherectomy System from Abbott
- Where
- United Kingdom
- Volunteers
- 250 people
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe
Coronary Artery Disease
Rotational Atherectomy for Calcified lEsion By Smart Angioplasty Research Team (SMART-RACE)
Current guidelines recommend the use of rotational atherectomy (RA) for preparation of heavily calcified or severely fibrotic lesions that cannot be crossed by a balloon or adequately dilated before planned stenting (bailout…
- Trial name
- NCT02716363
- Testing
- Rotational Atherectomy by Rotablator
- Where
- South Korea
- Volunteers
- 500 people
- Sponsor
- Samsung Medical Center
Coronary Atherosclerosis, Coronary Artery Calcification
Firefighter Aged Garlic Extract Investigation With CoQ10 as a Treatment for Heart Disease (FAITH)
1. Statement of Problem According to the National Fire Protection Association (NFPA), 43.7% of all firefighters that died on the job experienced sudden cardiac death. The job also affords an incredible amount of stress.
- Conditions
- Coronary Atherosclerosis, Coronary Artery Calcification, Coronary Stenosis
- Trial name
- NCT00860847
- Testing
- Aged garlic extract and Coenzyme Q10
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Type 1 Diabetes, Coronary Artery Calcification
Cardiovascular Risk Stratification in Young People With Type 1 Diabetes
The aim of the study is to compare ESC recommendations on cardiovascular (CV) risk stratification with the achievement of a CAC (Coronary Artery Calcification).
- Trial name
- CACD1 (NCT05283538)
- Testing
- Coronary Artery Calcification Realization
- Where
- France
- Volunteers
- 91 people
- Sponsor
- Poitiers University Hospital
Cardiovascular Disease, Coronary Artery Calcification
7 Year Follow-up Study of the DanRisk Population
OBJECTIVES: To investigate the incidence of cardiovascular events as well as progression of coronary artery calcium (CAC) in healthy middle-aged subjects over a period of 7 years, and the relation to traditional as well as new…
- Conditions
- Cardiovascular Disease, Coronary Artery Calcification, Atherosclerosis
- Trial name
- NCT02913144
- Volunteers
- 1,257 people
- Sponsor
- Odense University Hospital
Peripheral Artery Disease, End Stage Renal Disease on Dialysis
A Cross-Sectional Study to Assess Walking Performance in Subjects With Peripheral Artery and End Stage Kidney Disease
A cross-sectional, non-interventional study to assess walking performance, vascular function, and lower limb calcification in subjects with peripheral artery disease and end-stage kidney disease (PAD-ESKD) receiving hemodialysis.
- Trial name
- NCT04487301
- Where
- 7 sites in United States
- Volunteers
- 36 people
- Sponsor
- Sanifit Therapeutics S. A.
Coronary Artery Calcification, Metabolic Syndrome
High-intensity Statin and Ezetimibe Therapy for Asymptomatic Patients With Positive Coronary Calcium
The aim of this study is to compare safety and efficacy between the aggressive treatment with combination of high-intensity statin and ezetimibe and the current standard lipid lowering treatment in asymptomatic patients with…
- Conditions
- Coronary Artery Calcification, Metabolic Syndrome, Dyslipidemias
- Trial name
- DECISION-CAL (NCT05845424)
- Testing
- Guideline directed statin therapy, High intensity statin plus ezetimibe therapy
- Where
- South Korea
- Volunteers
- 6,000 people
- Sponsor
- Samsung Medical Center
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
Severely Calcified Coronary Stenoses, De Novo Stenosis
Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions
Percutaneous coronary intervention (PCI) encounters challenges with calcified coronary lesions, leading to potential issues such as failed balloon dilatation, incomplete stent expansion, and increased risks of adverse events…
- Trial name
- REC-CHIPCAC (NCT06238518)
- Testing
- Intravascular Lithotripsy, Conventional lesion preparation strategy
- Where
- China
- Volunteers
- 220 people
- Sponsor
- Xijing Hospital
Peripheral Artery Disease (PAD), Chronic Limb Threatening Ischemia
Angioplasty With Shockwave IVL Catheter System in Femoropopliteal Lesions
There is a lack of prospective observational studies of shockwave balloons in the treatment of moderate-to-severe calcification of the femoral popliteal artery at the international level.
- Trial name
- SHIELD (NCT06713850)
- Testing
- Shockwave balloons
- Where
- China
- Volunteers
- 130 people
- Sponsor
- Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Safety Issues, Efficacy, Self
Lower Silesian Orbital Atherectomy Registry (LOAR)
The Lower Silesian Orbital Atherectomy Registry (LOAR), is an observational registry collecting all consecutive cases of percutaneous coronary intervention (PCI) performed with the support of the Orbital Atherectomy Device due to…
- Trial name
- LOAR (NCT06451146)
- Testing
- PCI Facilitated with Orbital Atherectomy Device
- Where
- 2 sites in Poland
- Volunteers
- 500 people
- Sponsor
- Miedziowe Centrum Zdrowia SA
Coronary Artery Calcification, Angioplasty
CAlcified Lesion Intervention Planning Steered by OCT.
Calcified lesions are very frequent among coronary artery disease stenotic lesions. The prevalence of calcifications ranges from 30 to 40% (by angiography evaluation) but is higher when analyzed by intra coronary imaging.
- Trial name
- CALIPSO (NCT05301218)
- Testing
- angioplasty
- Where
- 14 sites in France
- Volunteers
- 140 people
- Sponsor
- Institut Mutualiste Montsouris
Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease
Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease
The PATHFINDER Registry is a prospective, non-randomized, single arm, multicenter observational study. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term)…
- Conditions
- Infrainguinal Peripheral Artery Disease, Peripheral Arterial Disease, PAD
- Trial name
- PATHFINDER (NCT04229563)
- Testing
- AURYON Atherectomy System
- Where
- 10 sites in United States
- Volunteers
- 102 people
- Sponsor
- Angiodynamics, Inc.
Aortic Diseases, Aorto-Iliac Atherosclerosis
Use of Shockwave M5+/L6 IVL Catheter (Intravascular Lithotripsy) in Hostile and Calcified Iliac Access
The study will evaluate, in a controlled setting, the efficacy and safety of the intravascular lithotripsy using Shockwave™ M5+/L6 Peripheral Intravascular Lithotripsy Catheter to facilitate delivery of aortic large-bore devices…
- Conditions
- Aortic Diseases, Aorto-Iliac Atherosclerosis, Peripheral Arterial Disease
- Trial name
- SHOCK-ACCESS (NCT05880641)
- Where
- 6 sites in Italy
- Volunteers
- 40 people
- Sponsor
- EndoCore Lab s.r.l.
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, 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
Vascular Calcification, Atherosclerosis of Artery
Potential Cross-Talk Between Arterial Calcifications
Potential Cross-Talk Between Arterial Calcifications Background Vascular calcification is a key component of atherosclerosis. This study investigates the potential correlations between aortic and coronary calcifications detected…
- Trial name
- PCTBAC (NCT06895265)
- Where
- Turkey (Türkiye)
- Volunteers
- 921 people
- Sponsor
- Ankara Ataturk Sanatorium Training and Research Hospital
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 Artery Calcification
A Novel Ferumoxytol-enhanced Cardiac Magnetic Resonance for the Detection of Calcified Coronary Arteries
This study is a single-center, prospective, controlled, diagnostic study. The study will be consecutive and is expected to enroll 100 patients with CCTA confirmed coronary calcified lesions.
- Trial name
- NCT07400406
- Testing
- Superparamagnetic Iron Oxide Nanoparticles
- Where
- China
- Volunteers
- 100 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
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