Clinical trials: Coronary Artery Calcification
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)
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 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, 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.
Coronary Artery Disease
A Clinical Trial to Assess the Elixir Medical LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter
The objective of the PINNACLE I Clinical Study is to assess safety and performance of the LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX) to treat moderately to severely…
- Trial name
- PINNACLE-I (NCT05828173)
- Testing
- LithiX Coronary Hertzian Contact Intravascular Lithotripsy Catheter (LithiX Coronary HCIVLC; LithiX)
- Where
- 7 sites in Belgium, Netherlands
- Volunteers
- 60 people
- Sponsor
- Elixir Medical Corporation
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
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.
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 Artery Disease, Percutaneous Coronary Intervention (PCI)
A Randomized Study of Cutting Balloon Catheter for CAD
This study is designed as a prospective, multi-center, non-inferiority and randomized controlled clinical trial. A total of 158 eligible subjects from 18 sites across the country is planned to be enrolled, and they will be…
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention (PCI), Calcified Coronary Lesions
- Trial name
- NCT07140822
- Testing
- Coronary Cutting Balloon Catheter, VesscideTM Cutting Balloon System
- Where
- China
- Volunteers
- 166 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
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.
Coronary Artery Disease, Intravascular Lithotripsy
Evaluate the Safety and Efficacy of Intracoronary Lithotripsy Balloon Catheter and Intracoronary Lithotripsy Apparatus
This is a prospective, multi-center, single-group target value clinical trial, which will be carried out in many clinical trial institutions in China.
- Trial name
- NCT05649488
- Testing
- Intracoronary lithotripsy balloon catheter and Intracoronary lithotripsy apparatus, Dragonfly Opstar Imaging Catheter
- Where
- 20 sites in China
- Volunteers
- 184 people
- Sponsor
- Shanghai Bluesail Boyuan Medical Technology Co., Ltd.
Coronary Artery Disease
BM Shockwave Devices Clinical Study in Coronary Calcified Lesions
This clinical trial is a prospective, multicenter, single-arm, target-value study to verify the safety and efficacy of BM coronary shockwave devices for the treatment of coronary calcification lesions.
- Trial name
- NCT07010094
- Testing
- BM shockwave devices
- Where
- China
- Volunteers
- 198 people
- Sponsor
- BrosMed Medical Co., Ltd