Prospective, Multicenter, Single-group Clinical Trial Evaluating the Safety and Effectiveness of ShockPulse-10 in the Treatment of Coronary Artery Calcification
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Coronary Arterial Disease (CAD)
- Sponsor
- Keya Medical
- Enrollment
- 205
- Locations
- 1
- Primary Endpoint
- Procedure success
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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 .
Detailed Description
The study will be conducted at 8 sites in China and up to 205 participants will be followed for 180 days post procedure. Patients ≥18 years of age scheduled for stent procedure with evidence of significant calcified stenosis of left main, or left anterior descending, right coronary artery or left circumflex will be eligible to enroll in the study. The primary endpoint of the study will evaluate procedure success,procedure success defined as successful stent implantation, residual stenosis degree ≤30% , and no major adverse cardiac events (MACE) occurring during hospitalization.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient is ≥ 18 years of age;
- •Patients with significant coronary artery disease (including stable or unstable angina and asymptomatic myocardial ischemia) who are suitable for PCI treatment;
- •A single newly developed stenosis of the target vessel, which is the left anterior descending artery, right coronary artery, or circumflex artery (or its branches), with stenosis degree ≥70% or ≥50% (Visually inspect ) and accompanied by evidence of ischemia;
- •The target lesion is a primary, in situ coronary artery lesion;
- •The reference vessel diameter for the target lesion is 2.0-4.0mm, and the length of the target lesion is ≤40mm (Visually inspect);
- •Visual assessment indicates that the lesion site can accommodate the passage of a pre-dilator or trial instrument through the lesion;
- •The target lesion site has moderate to severe calcification (meeting one of the following conditions)：
- •① Angiography: Moderate calcification :clearer and more easily visible high-density shadows during cardiac pulsation; Severe calcification :clear high-density shadows both during and at rest;
- •② IVUS calcium score ≥2 points for superficial intimal, deep medial, and mixed calcification;
- •TIMI grade 3 in target vessel before registration (pre-dilation is allowed);
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Procedure success
Time Frame: immediately post-procedure or prior to discharge, whichever comes first
Procedure success defined as successful stent implantation, residual stenosis degree ≤30% , and no major adverse cardiac events (MACE) occurring during hospitalization
Freedom from major adverse cardiac events (MACE) within 30 days of the index procedure
Time Frame: 30（±7days）days post index procedure
Freedom from major adverse cardiac events (MACE) within 30(±7days) days of the index procedure；MACE is defined as:Cardiac death; or Myocardial Infarction (MI): or Target Vessel Revascularization