Clinical trials: Coronary Arteries Calcifications
Coronary Artery Disease, Myocardial Infarction
Disrupt CAD IV With the Shockwave Coronary IVL System
The study design is a prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries…
- Trial name
- NCT04151628
- Testing
- Lithotripsy
- Where
- 8 sites in Japan
- Volunteers
- 72 people
- Sponsor
- Shockwave Medical, Inc.
Calcinosis, Arteriosclerosis
CARE-2 (Calcium Acetate [PhosLo®]/Sevelamer[Renagel®] Evaluation Study 2) for Heart Calcification in Dialysis Patients
The purpose of the study is to evaluate the effects of two phosphate binders, PhosLo and sevelamer, on heart calcification in dialysis patients.
- Conditions
- Calcinosis, Arteriosclerosis, Hyperparathyroidism, Secondary
- Trial name
- NCT00211939
- Testing
- calcium acetate, sevelamer, atorvastatin
- Where
- United States
- Volunteers
- 203 people
- Sponsor
- Nabi Biopharmaceuticals
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, 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.
Calcification of Coronary Artery
Coronary Atherectomy System in Patients With Coronary Calcification (CORECT)
This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary atherectomy system for the treatment of patients with coronary calcification.
- Trial name
- NCT05447585
- Testing
- Coronary atherectomy system of Shanghai MicroPort Rhythm, Rotablator Rotational Atherectomy System
- Where
- China
- Volunteers
- 239 people
- Sponsor
- Shanghai MicroPort Rhythm MedTech Co., Ltd.
Chronic Kidney Disease, End Stage Renal Disease
ADVANCE: Study to Evaluate Cinacalcet Plus Low Dose Vitamin D on Vascular Calcification in Subjects With Chronic Kidney Disease Receiving Hemodialysis
The purpose of this study is to evaluate whether cinacalcet + low dose vitamin D attenuates the progression of vascular calcification over one year, compared with a treatment regimen that includes flexible vitamin D dosing in the…
- Conditions
- Chronic Kidney Disease, End Stage Renal Disease, Coronary Artery Calcification, Vascular Calcification
- Trial name
- NCT00379899
- Testing
- cinacalcet
- Volunteers
- 360 people
- Sponsor
- Amgen
Optical Coherence Tomography, Intravascular Ultrasound
OCT vs IVUS vs QCA to Guide Moderate-to-severe Calcified Lesion Stent Implantation
This study is a prospective, multi-center, randomized controlled clinical trial, aims to assess the safety and effectiveness of Optical Coherence Tomography or Intravascular Ultrasound or Quantitative Coronary Analysis to guide…
- Conditions
- Optical Coherence Tomography, Intravascular Ultrasound, Angiography
- Trial name
- NCT03574636
- Testing
- OCT guidance, IVUS guidance, QCA
- Where
- China
- Volunteers
- 375 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Diabetes, Coronary Artery Calcification
A Study Comparing Skin Fluorescence to Coronary Artery Calcification
This study examines the relationship between the SCOUT DM device and coronary artery calcification as determined by rapid computed tomography in patients at risk for coronary heart disease.
- Trial name
- CACS (NCT00895427)
- Where
- United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- VeraLight, Inc.
Coronary Artery Disease
Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE)
The objective of this study is to assess the current standard of care treatment outcome in none/mild, moderate and severely calcified coronary lesions using: A composite of MACE at 30-day and one (1) year post procedure, and…
- Trial name
- MACE (NCT01930214)
- Testing
- Percutaneous Coronary Intervention
- Where
- 34 sites in United States
- Volunteers
- 350 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease, Calcifications Vascular
SOLSTICE Trial in China
This is a small sample size clinical trial in Chinese population to assess the safety and effectiveness of the Shockwave Coronary Intravascular Lithotripsy (IVL) System to treat de novo, calcified, stenotic, coronary lesions…
- Trial name
- NCT05433376
- Testing
- Shockwave Coronary Intravascular Lithotripsy (IVL) System C2
- Where
- 3 sites in China
- Volunteers
- 20 people
- Sponsor
- Genesis Medtech Corporation
Coronary Stenosis
Shockwave Coronary Lithoplasty Study
The objective of this clinical trial is to study the early safety and feasibility of the Shockwave Coronary Lithoplasty System. To demonstrate that the Shockwave device can safely and effectively deliver localized shockwave…
- Trial name
- NCT02758379
- Testing
- Shockwave Coronary Lithoplasty System
- Where
- Australia
- Volunteers
- 12 people
- Sponsor
- Shockwave Medical, Inc.
Coronary Arterial Disease (CAD), Calcification; Heart
The Safety and Performence of ShockPulse-10 in Patients with Coronary Artery Calcification
This study is an exploratory, multicenter, single-group clinical trial aimed to evaluate the clinical outcomes of using ShockPulse-10 in the treatment of coronary artery calcification .
- Trial name
- NCT06711822
- Testing
- Shockplus-10
- Where
- China
- Volunteers
- 205 people
- Sponsor
- Keya Medical
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 Calcification
Coronary Intravascular Lithotripsy System in Patients With Coronary Artery Calcification (VIGOUR)
This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary intravascular lithotripsy system for the treatment of patients with coronary calcification.
- Trial name
- NCT05818098
- Testing
- Intravascular Lithotripsy System of Shanghai MicroPort Rhythm
- Where
- China
- Volunteers
- 189 people
- Sponsor
- Shanghai MicroPort Rhythm MedTech Co., Ltd.
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 Disease (CAD), Stenosis Coronary
Brazilian Prospective Registry of the Inspiron EVO Drug-Eluting Stent in Complex Coronary Lesions
The objective is to evaluate the efficacy and safety of the Inspiron™ EVO drug-eluting stent in complex coronary lesions in a real-world population.
- Conditions
- Coronary Artery Disease (CAD), Stenosis Coronary, Small Vessel Ischemic Disease, Multivessel Coronary Artery Disease
- Trial name
- PCI EVOlution (NCT07491107)
- Testing
- Inspiron EVO Drug-Eluting Stent
- Where
- Brazil
- Volunteers
- 2,000 people
- Sponsor
- Scitech Produtos Medicos SA
Coronary Artery Calcification, Coronary Artery Disease
TECTONIC CAD IVL IDE Study
A prospective, single-arm, open-label, multi-center IDE study with up to 55 US sites
- Conditions
- Coronary Artery Calcification, Coronary Artery Disease, Stenotic Coronary Lesion
- Trial name
- TECTONIC (NCT06885177)
- Testing
- Experimental
- Where
- 40 sites in United States
- Volunteers
- 335 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Shockwave Coronary Rx Lithoplasty® Study (Disrupt CAD I)
Prospective, multi-center, single arm study designed to evaluate the safety and performance of the Shockwave Coronary Rx Lithoplasty® System to treat calcified lesions in the coronary arteries for the purpose of enhancing the…
- Trial name
- NCT02650128
- Testing
- Shockwave Coronary Rx Lithoplasty® System
- Where
- 7 sites in Australia, France and 3 more
- Volunteers
- 60 people
- Sponsor
- Shockwave Medical, Inc.
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, 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.