Clinical trials: Arterial Calcification, open to volunteers
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
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 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
Safety Issues, Efficacy, Self
The Lower Silesia Shockwave Registry
Lower Silesia Shockwave Registry (LSSR), is a observational registry collecting all consecutive cases of percutaneous coronary intervention (PCI) performed with the support of shockwave intravascular lithotripsy in two…
- Trial name
- LSSR (NCT05916898)
- Testing
- PCI with support of Shockwave Intravascular Lithotripsy
- Where
- 2 sites in Poland
- Volunteers
- 400 people
- Sponsor
- Miedziowe Centrum Zdrowia SA
Coronary Arterial Disease (CAD), In Stent Restenosis
OPN Balloon for SAFE Recanalization of Calcified Coronary Lesions
The goal of the OPEN-SAFE registry is to describe the contemporary use and outcomes of SIS-OPN in North America.
- Conditions
- Coronary Arterial Disease (CAD), In Stent Restenosis, Calcified Coronary Lesions
- Trial name
- OPEN-SAFE (NCT07646444)
- Testing
- non compliant balloon
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Minneapolis Heart Institute Foundation
Coronary Artery Calcification
ROVUS Asia Registry (Evaluate Safety and Effectiveness of Rotational Atherectomy and Intravascular Ultrasound for Heavily Calcified Coronary Lesion)
Rotablation with or without other calcium debulking therapies is a safe adjunctive procedure for patients with severe coronary calcification requiring Percutaneous Coronary Intervention (PCI).
- Trial name
- ROVUS (NCT04742478)
- Testing
- Rotational Atherectomy
- Where
- 2 sites in Japan, Singapore
- Volunteers
- 1,000 people
- Sponsor
- National Heart Centre Singapore
Coronary Artery Calcification, Coronary Artery Disease
Intravascular Imaging-Guided Intravascular Lithotripsy for Severe Coronary Calcified Lesions.
This study aims to investigate the efficacy and safety of intravascular lithotripsy (IVL) balloon in treating coronary calcified lesions at our center.
- Trial name
- NCT07444346
- Testing
- percutaneous coronary intervention
- Where
- China
- Volunteers
- 200 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Carotid Artery Calcification, Carotid Artery Diseases
Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral Stenting (SKYWARD Trans-Femoral IDE [Investigational Device Exemption] Study)
Prospective, Multi-center, Single-arm Study of the Shockwave Medical SkyRunner Carotid Intravascular Lithotripsy (IVL) System for the Treatment of Calcified Carotid Arteries Prior to Trans-Femoral stenting (SKYWARD Trans-Femoral…
- Trial name
- SKYWARD TF (NCT07512128)
- Testing
- Carotid Intravascular Lithotripsy
- Where
- 25 sites in United States
- Volunteers
- 185 people
- Sponsor
- Shockwave Medical, Inc.
Coronary Disease, Coronary Artery Disease
SIROOP Registry - A Prospective Registry Study to Evaluate the Outcomes of Coronary Artery Disease Patients Treated With SIROlimus Or Paclitaxel Eluting Balloon Catheters
The purpose of the SIROOP Registry is to retrospectively and prospectively collect baseline, clinical and procedural characteristics of patients who have undergone PCI and are treated with either currently available sirolimus or…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis, Coronary Arteriosclerosis
- Trial name
- SIROOP (NCT04988685)
- Testing
- Sirolimus Eluting Balloon
- Where
- Switzerland
- Volunteers
- 2,000 people
- Sponsor
- Luzerner Kantonsspital
Coronary Arterial Disease
Safety and Effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter Combined With the Intravascular Lithotripsy Therapy Device
The FORWARD IVL trial is a Prospective, Multicenter Study conducted to assess the safety and effectiveness of the Single-Use Coronary Forward Intravascular Lithotripsy Catheter combined with the Intravascular Lithotripsy Therapy…
- Trial name
- FORWARD IVL (NCT07109479)
- Testing
- Intravascular Lithotripsy, Rotational Atherectomy
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Spectrumedics Medical Technology(Shanghai)Co.,Ltd
Coronary Artery Disease, Atherosclerosis
Measuring Athlete's Risk of Cardiovascular Events 3 (MARC-3)
Regular endurance exercise is widely known to improve cardiovascular health and reduce the risk of heart disease. Yet several imaging studies have shown that male endurance athletes have a higher prevalence of coronary artery…
- Trial name
- MARC-3 (NCT07625488)
- Where
- 2 sites in Netherlands
- Volunteers
- 250 people
- Sponsor
- Radboud University Medical Center
Coronary Artery Disease, Coronary Disease
Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions
Clinical research with medical devices indicated in accordance with the CE marking, led by researchers, multicenter, open, prospective, randomized and controlled.
- Trial name
- OraBil (NCT06736899)
- Testing
- Orbital Atherectomy System Treatment, Balloon System Treatment
- Where
- 9 sites in Spain
- Volunteers
- 200 people
- Sponsor
- Fundación EPIC
Trans-femoral TAVI With Calcified Ilio-femoral Arteries
TRAns-Femoral Access Intravascular Lithotripsy Comparison With PTA in TAVI
To compare the effectiveness and the safety of femoral-iliac IVL versus balloon only PTA for successful deployment of transfemoral transcatheter aortic valve prosthesis.
- Trial name
- TRAFIC-PTA (NCT05873842)
- Testing
- Trans-femoral TAVI
- Where
- 5 sites in Italy
- Volunteers
- 50 people
- Sponsor
- Rede Optimus Hospitalar SA
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
The goal of this observational study is to better understand how the amount of insulin people with type 1 diabetes are using relates to blood glucose control and the risk of complications.
- Conditions
- Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD), Severe Albuminuria, Estimated Glomerular Filtration Rate (eGFR)
- Trial name
- iDose-EDC (NCT07911033)
- Testing
- Routine/prescribed exogenous insulin dose
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Rachel Miller
Coronary Artery Disease
DEBSCAN-IVL. Drug Eluting Balloon or Drug Eluting Stent to Treat CAlcified Nodules After IntraVascular Lithotripsy.
International, investigator-driven, multicenter, open-label, prospective randomized controlled trial where patients with de novo lesions due to calcified nodules (CN) were randomized to drug eluting balloon (DEB) or drug eluting…
- Trial name
- DEBSCAN-IVL (NCT06657833)
- Testing
- Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting balloon, Percutaneous coronary intervention of a calcified nodule with intravascular lithotripsy followed by drug eluting stent
- Where
- 15 sites in Netherlands, Spain
- Volunteers
- 128 people
- Sponsor
- Fundación EPIC
Stroke, Acute, Ischemic Stroke
The Correlation of Intracranial Artery Calcification and Outcomes of Mechanical Thrombectomy
CAIS-MT is a single-center, prospective cohort study, to evaluate the correlation between outcomes of endovascular treatment(EVT) and intracranial artery calcification(IAC) in patients with acute ischemic stroke due to large or…
- Conditions
- Stroke, Acute, Ischemic Stroke, Vascular Diseases, Central Nervous System Diseases
- Trial name
- CAIS-MT (NCT06418698)
- Where
- China
- Volunteers
- 434 people
- Sponsor
- Zhujiang Hospital
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
Femoral Artery Stenosis, Angioplasty
an Observational Study Evaluting the Effectiveness and Safety of DKutting LL Noval Scoring Balloon Angioplasty for Vessel Preparation Facilitated by IVUS on the Lower Limb Ischemia Patients With Calcified Lesions
This is a prospective, single-center, single-arm, observational study. It plans to enroll 58 patients with moderate to severely calcified lesions in the femoropopliteal or infrapopliteal arteries.
- Conditions
- Femoral Artery Stenosis, Angioplasty, Cutting Balloon Angioplasty, Calcifications, Vascular
- Trial name
- DkuLL CALVEP (NCT07397390)
- Testing
- DKutting LL scoring balloon angioplasty
- Where
- China
- Volunteers
- 58 people
- Sponsor
- The First Affiliated Hospital of Dalian Medical University
Calcifications, Vascular
Ultrasound Assessment of Arterial Medial Calcification in Endurance Athletes: A Prevalence Study
Medial arterial calcification (MAC) is an under-recognized vascular condition that remains poorly characterized from an epidemiological perspective.
- Trial name
- EMASE (NCT07419126)
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University Hospital, Grenoble
Heterozygous Familial Hypercholesterolemia (HeFH)
"Detection and Follow-up of Coronary Lesions in HeFH (DESTINY-FH Study)"
This multicenter, non-randomized interventional study aims to assess coronary artery disease progression over 5 years in patients with genetically confirmed heterozygous familial hypercholesterolemia (HeFH), using coronary…
- Trial name
- DESTINY-FH (NCT07427472)
- Testing
- Coronary computed tomography angiography
- Where
- 3 sites in France
- Volunteers
- 300 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris