Clinical trials: Vascular Calcification, active
Coronary Artery Disease, Ischemic Heart Disease
Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts: The ECLIPSE Trial
This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES).
- Conditions
- Coronary Artery Disease, Ischemic Heart Disease, Non ST Segment Elevation Myocardial Infarction
- Trial name
- ECLIPSE (NCT03108456)
- Testing
- Orbital Atherectomy, Balloon
- Where
- 104 sites in United States
- Volunteers
- 2,005 people
- Sponsor
- Abbott Medical Devices
Peripheral Arterial Disease
Comparison of a Lithotripsy vs Standard Preparation Followed by Stenting With Supera Stent in Femoropopliteal Lesions
This study is an investigator-initiated, prospective, single-center, 1:1 randomized pilot study. The trial evaluates the safety and efficacy of intravascular lithotripsy in comparison to standard lesion preparation using standard…
- Trial name
- CRACK-IT (NCT06112171)
- Testing
- Intravascular lithotripsy, Standard lesion preparation
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- University of Leipzig
Calcific Aortic Stenosis, Calcific Aortic Stenosis - Bicuspid Valve
Identification of Genetic Causes of Calcific Aortic Valve Disease
This study aims to identify the molecular genetic causes of the variability in development of calcific aortic valve disease in bicuspid and tricuspid aortic valves and their associated aortic dilation.
- Conditions
- Calcific Aortic Stenosis, Calcific Aortic Stenosis - Bicuspid Valve, Aortic Valve Disease, Aortic Valve Calcification
- Trial name
- NCT04149600
- Testing
- Patients scheduled to undergo aortic valve replacement or aortic surgery at BIDMC will be approached for participation in this study.
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
Septic Shock, Calcium Sensing Receptor
Impact of Vascular Calcification and CASR Expression by Monocytes in Septic Shock
In septic shock, bacterial LPS is able to activate the CaSR of cardiomyocytes inducing their apoptosis in vitro. CaSR activation in monocytes is responsible for activation of the NLRP3 inflammasome and macropinocytosis.
- Conditions
- Septic Shock, Calcium Sensing Receptor, Calcium Phosphate Disorders, Inflammation
- Trial name
- CASRCHOC (NCT06853340)
- Testing
- blood sampling
- Where
- France
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Centre Hospitalier Universitaire, Amiens
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
Aortic Valve Stenosis, Aortic Valve Calcification
ACURATE neo2™ Post Market Clinical Follow up Study
The ACURATE Neo2 PMCF is aimed at collecting clinical and device performance outcomes data with the ACURATE neo2™ Transfemoral Aortic Valve System as used in routine clinical practice for the treatment of severe calcific aortic…
- Conditions
- Aortic Valve Stenosis, Aortic Valve Calcification, Aortic Diseases
- Trial name
- NCT04655248
- Testing
- Transcatheter Aortic Valve Implantation/Replacement
- Where
- 19 sites in Denmark, Germany and 6 more
- Volunteers
- 250 people
- Sponsor
- Boston Scientific Corporation
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
Cardio Vascular Disease
An Study Looking at Percutaneous Coronary Intervention Outcomes for Octogenarians
The goal of this observational study is to understand the makeup of the participants aged 80 years and older who had stents fitted or balloon expansion of their heart arteries, otherwise known as percutaneous coronary…
- Trial name
- NCT07633964
- Testing
- Percutaneous Coronary Intervention
- Where
- United Kingdom
- Volunteers
- 850 people
- Sponsor
- Gloucestershire Hospitals NHS Foundation Trust
Chronic Limb Threatening Ischemia, Chronic Limb-Threatening Ischemia
REsorbable SCaffolds With everolimUs-Elution for the Treatment of Infrapopliteal Artery Disease in Patients With Chronic Limb-threatening Ischemia
RESCUE is a Europe-wide study that will follow 400 people with critical limb-threatening ischemia (CLTI). It aims to see how well Esprit BTK™ Everolimus Eluting Resorbable Scaffolds work in real-life medical settings.
- Trial name
- RESCUE (NCT07270575)
- Testing
- Esprit BTK™ Everolimus Eluting Resorbable Scaffold from Abbott
- Where
- United Kingdom
- Volunteers
- 400 people
- Sponsor
- Cardiovascular and Interventional Radiological Society of Europe
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
End-Stage Kidney Disease (ESKD), Hemodialysis
Cardiovascular and Bone Mineral Markers in Dialysis Patients and Healthy Controls
This observational study will compare cardiovascular status, bone mineral metabolism, systemic inflammation, body composition, functional status, quality of life, pruritus, and pain among patients receiving different renal…
- Conditions
- End-Stage Kidney Disease (ESKD), Hemodialysis, Peritoneal Dialysis (PD)
- Trial name
- NCT07686978
- Where
- Turkey (Türkiye)
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Gazi University
Peripheral Artery Disease, Peripheral Artery Stenosis
The THOR IDE Study
The goal of this clinical trial is to test the Thor system in adult (≥ 18 year old) patients with de novo (new, never treated) calcified lesions in infrainguinal (leg) arteries (peripheral artery disease or PAD).
- Conditions
- Peripheral Artery Disease, Peripheral Artery Stenosis, Peripheral Artery Calcification, PAD
- Trial name
- THOR (NCT05916950)
- Testing
- Thor laser atherectomy
- Where
- 29 sites in United States
- Volunteers
- 155 people
- Sponsor
- Philips Clinical & Medical Affairs Global
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
Nonfatal Stroke, Nonfatal Myocardial Infarction
Coronary CT Angiogram - Prognostic Value of Adverse Plaque Features in Guiding Treatment (CT-PLAQUE)
The study aims at determining if the presence of adverse plaque features identified from the CT angiogram can help determine prognosis and guide treatment options.
- Conditions
- Nonfatal Stroke, Nonfatal Myocardial Infarction, Cardiovascular Death, All-cause Death
- Trial name
- CT-PLAQUE (NCT07212751)
- Testing
- CTCA
- Where
- Hong Kong
- Volunteers
- 22,000 people
- Sponsor
- The University of Hong Kong
Vascular Disease, CKD-MBD - Chronic Kidney Disease Mineral and Bone Disorder
Biomarkers and Event Patterns of Vascular Disease in Hemodialysis
Parathyroid hormone (PTH) remains the central biomarker to classify CKD-metabolic bone disease (CKD-MBD) in hemodialysis patients.
- Trial name
- HEMOcalc (NCT07170761)
- Where
- Austria
- Volunteers
- 475 people
- Sponsor
- Medical University of Graz
Mild Autonomous Cortisol Secretion (MACS)
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
To characterize the impact of Isturisa on clinical features and comorbidities associated with MACS. The investigators hypothesize that patients treated with Isturisa will exhibit significantly better metabolic indicators (such as…
- Trial name
- NCT07247058
- Testing
- Osilodrostat (Isturisa)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Johns Hopkins University
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
Chronic Kidney Disease Requiring Chronic Dialysis, Cardiovascular Calcification
The Intravenous Amino Acid Therapy for Vascular Rigidity in End Stage Renal Disease
The goal of this study is to learn if giving amino acids through the dialysis machine can help protect the blood vessels and heart in people with kidney failure.
- Trial name
- NASCAR (NCT07392697)
- Testing
- Amino Acid Supplementation, Sterile Saline Arm
- Where
- Norway
- Volunteers
- 120 people
- Sponsor
- Haukeland University 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