A Prospective, Multicenter Clinical Trial in Evaluating the Safety and Efficacy of the Intravascular Lithotripsy System in Patients With Coronary Artery Calcification
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Coronary Artery Calcification
- Sponsor
- Shanghai MicroPort Rhythm MedTech Co., Ltd.
- Enrollment
- 189
- Locations
- 1
- Primary Endpoint
- Procedure success
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
This trial is a prospective and multicenter clinical trial. 189 subjects are expected to be recruited in 20 research centers in China. 1. All subjects with coronary calcified lesions participating in this clinical study must have only one lesion length of no more than 40 mm and located in an coronary artery with a diameter of ≥ 2.00 mm but ≤ 4.00 mm. 2. All subjects receive clinical follow-up during hospitalization, 30 days and 6 months after surgery.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Clinical Inclusion Criteria:
- •Subjects aged between 18 and
- •Subjects who can undergo percutaneous coronary intervention (PCI).
- •Subjects with asymptomatic evidence of ischemia, stable or unstable angina pectoris, or old myocardial infarction.
- •Left Ventricular Ejection Fraction (LVEF) ≥30% as measured by echocardiography for subjects within 6 months before enrollment. (In case of multiple LVEF results, the data closest to the baseline procedure was taken.)
- •Subjects who are able to understand the purpose of the trial, participate voluntarily or by proxy and indicate by signing the informed consent form that they recognize the risks and benefits described in the informed consent document and are willing to undergo clinical follow-up.
- •Angiography Inclusion Criteria:
- •There is only one target lesion that needs to be treated.
- •The target lesion must be located in a de novo native coronary artery with a reference vessel diameter (RVD) ≥2.00 mm to ≤4.00 mm as visually measured.
- •The target lesion angiography shows a stenosis rate ranging from ≥70% (visually measured) or ≥50% to \<70% with symptoms of ischemia.
Exclusion Criteria
- •General Exclusion Criteria:
- •Subjects who present with AMI recently (within 7 days)
- •Subjects who have hemodynamic instability or a severe reduction in activity tolerance (NYHA cardiac function Grade Ⅲ, Ⅳ).
- •Subjects who have an intra-cardiac thrombus as shown by echocardiography within 30 days before enrollment.
- •Subjects who have already received or are waiting for organ transplantation.
- •Subjects who are receiving or scheduled to receive chemotherapy within 30 days before or after the baseline procedure.
- •Subjects who have a platelet count \< 60 x 10\^9/L or \> 750 x 10\^9/L or other hemorrhagic diathesis, coagulation dysfunction, blood transfusion resistance.
- •Subjects who have severe hepatic dysfunction (transaminases more than 3 times the upper limit of normal).
- •Subjects who have chronic renal failure and a serum creatinine level \> 2.5 mg/Dl (or 221µmol/L).
- •Subjects who have active peptic ulcer diseases or active gastrointestinal (GI) bleeding within 6 months before enrollment.
Outcomes
Primary Outcomes
Procedure success
Time Frame: During hospitalization (up to 7 days after procedure)
Procedure success is defined as the ability of intravascular lithotripsy (IVL) to produce residual diameter stenosis ≤30% after stenting with no evidence of in-hospital MACE (maximum of 7 days) (MACE: defined as the composite of cardiac death, myocardial infarction, and target vessel revascularization)
Secondary Outcomes
- Device success(Baseline procedure)
- Angiographic success(Baseline procedure)
- MACE freedom rate at 30 days after the index procedure(within 30 days of baseline procedure)
- Procedure-related serious complications(Baseline procedure)