A Prospective, Multicenter Clinical Trial of Coronary Atherectomy System in Patients With Calcified Coronary Artery Lesion
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Calcification of Coronary Artery
- Sponsor
- Shanghai MicroPort Rhythm MedTech Co., Ltd.
- Enrollment
- 239
- Locations
- 1
- Primary Endpoint
- RCT phase: 30-Day Freedom From Major Adverse Cardiac Events (MACE)
- Status
- Enrolling By Invitation
- 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 atherectomy system for the treatment of patients with coronary calcification.
Detailed Description
This study is divided into two phases. The first phase is the pilot study stage, which is a prospective single group observational test (FIM stage). The second phase is the pivotal study phase, which is a prospective, multicenter, randomized controlled and non inferiority test (RCT phase). It is carried out in about 25 hospitals in China. 1. Pilot study phase (FIM phase): It is a prospective, multicenter and single-arm observational test. It is expected to recruit 15 subjects in 3 to 5 research centers in China. The primary endpoint is procedural success rate. 2. Pivotal study phase (RCT phase): It is a prospective, multicenter, randomized controlled and non inferiority trial. 224 subjects are expected to be recruited in 25 research centers in China and randomly divided into two groups according to the ratio of test group: control group = 1:1. The primary endpoint of the RCT phase is the rate of no major adverse cardiovascular events (MACE) at 30 days after baseline. 3. All subjects with coronary calcified lesions participating in this clinical study must have a calcified lesion length of no more than 40 mm and located in an coronary artery with a diameter of ≥ 2.50 mm but ≤ 4.00 mm. 4. All subjects receive clinical follow-up during hospitalization and 30 days, 6 months and 12 months after surgery. 5. Successful enrollment: The atherectomy guidewires pass through the target lesion successfully (through the true lumen), and there are no vascular perforation, dissection, thrombosis and other complications.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age between 18 and
- •Subjects who are going to accept percutaneous coronary intervention (PCI) and drug-eluting stent implantation.
- •Asymptomatic evidence of ischemia, stable or unstable angina pectoris, or old myocardial infarction.
- •Acceptable candidates for coronary artery bypass grafting (CABG).
- •The left ventricular ejection fraction (LVEF) is equal to or greater than 30% measured by echocardiography or left ventricle contrast examination within 30 days before inclusion.
- •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 vessel must be a native coronary artery with reference diameter \>= 2.5mm and \<= 4.0 mm.
- •The target vessel must be with a stenosis of \>= 70% and \< 100%Target lesion angiographic stenosis, or of \>=50% and \<70% with local ischemic symptoms.
Exclusion Criteria
- •Acute myocardial infarction within 30 days prior to baseline procedure.
- •NYHA or Killip class III or IV heart failure.
- •Severe cardiac insufficiency with reduced ejection fraction (left ventricular ejection fraction \< 30%).
- •Intracardiac thrombus within 30 days before inclusion.
- •Subjects who have received organ transplantation or is waiting for organ transplantation.
- •Subjects who are receiving chemotherapy or scheduled to receive chemotherapy 30 days before or after baseline surgery.
- •Subjects who are receiving chronic (≥ 72 hours) anticoagulant therapy (e.g. heparin, warfarin, coumarin) for indications other than acute coronary syndrome.
- •Participants' platelet \< 50 × 10\^9 / L or \> 700 × 10\^9 / L, and / or hemoglobin \< 70g / L.
- •Subjects with confirmed or suspected liver diseases, including active hepatitis, or abnormal laboratory results are not suitable for the study.
- •Subjects diagnosed with chronic renal failure or has a serum creatinine level \>2.5 mg/dl (or 221 µmol / L).
Outcomes
Primary Outcomes
RCT phase: 30-Day Freedom From Major Adverse Cardiac Events (MACE)
Time Frame: 30 days after baseline procedure.
MACE is composed of cardiac death, myocardial infarction and target vessel revascularization.
FIM phase: Clinical success
Time Frame: During hospitalization (up to 7 days after baseline procedure).
Clinical success is defined as successful stent delivery with a residual stenosis of \<50% and TIMI flow III without adverse events during procedure the occurrence of an in-hospital MACE (up to 7 days after surgery).
Secondary Outcomes
- Device success(Baseline procedure)
- Procedure-related complications(Baseline procedure)
- Procedural success(Baseline procedure)