RecruitingNot ApplicableNCT06711822

The Safety and Performence of ShockPulse-10 in Patients with Coronary Artery Calcification

Prospective, Multicenter, Single-group Clinical Trial Evaluating the Safety and Effectiveness of ShockPulse-10 in the Treatment of Coronary Artery Calcification

Sponsor

Keya Medical

Enrollment

205 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Coronary Arterial Disease (CAD)Calcification; Heart

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 .

Eligibility

Min Age: 18 Years

Inclusion Criteria10

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 Criteria8

Left ventricular ejection fraction \< 40%；
NYHA class III or IV heart failure；
Patients with single coronary artery supply;
Patients with evidence of dissection at the site of the lesion on imaging;
The imaging suggests that the vascular pathway is tortuous, making it difficult for the pre-dilatation device to reach the target location or to be retrieved;
Patients with active systemic infections;
Patients with uncontrollable severe hypertension (systolic pressure \> 180 mmHg or diastolic pressure \> 110 mmHg);
Patients with coagulopathy, hypercoagulable state or significant bleeding tendency (hemoglobin \<10g/dL or platelet count \<80×10\^9/L);

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