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

Official title

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

Overview

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.

Interventions

• Device Shockplus-10
  Patients with coronary artery calcification who are planned to undergo PCI and are deemed in need of ShockPulse-10 treatment by their physicians

Primary outcome measures

• Procedure success [Time frame: immediately post-procedure or prior to discharge, whichever comes first]
• Freedom from major adverse cardiac events (MACE) within 30 days of the index procedure [Time frame: 30（±7days）days post index procedure]

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

• 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);

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Beijing Anzhen Hosipital — Beijing

Identifiers

NCT: NCT06711822 · 2024-27

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗