Evaluating ShockPulse-10 for treating coronary artery calcification

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

This study is testing a new treatment called ShockPulse-10 to see if it can safely help people with serious coronary artery calcification who are getting stents.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 205 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Keya Medical (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06711822 on ClinicalTrials.gov

What this trial studies

This exploratory, multicenter clinical trial aims to assess the safety and performance of ShockPulse-10 in patients with significant coronary artery calcification. Conducted at eight sites in China, the study will enroll up to 205 participants who are scheduled for stent procedures. Participants will be followed for 180 days post-procedure to evaluate clinical outcomes, including procedure success defined by successful stent implantation and the occurrence of major adverse cardiac events. The trial focuses on patients with specific criteria related to coronary artery disease and calcification.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with significant coronary artery disease and moderate to severe calcification in specific coronary arteries.

Not a fit: Patients with non-calcified lesions or those not suitable for PCI treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve outcomes for patients with coronary artery calcification undergoing stent procedures.

How similar studies have performed: While this approach is exploratory, similar interventions targeting coronary artery calcification have shown promise in other studies.

Eligibility criteria

Key Inclusion Criteria:

1. Patient is ≥ 18 years of age;
2. Patients with significant coronary artery disease (including stable or unstable angina and asymptomatic myocardial ischemia) who are suitable for PCI treatment;
3. 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;
4. The target lesion is a primary, in situ coronary artery lesion;
5. The reference vessel diameter for the target lesion is 2.0-4.0mm, and the length of the target lesion is ≤40mm (Visually inspect);
6. Visual assessment indicates that the lesion site can accommodate the passage of a pre-dilator or trial instrument through the lesion;
7. 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;
8. TIMI grade 3 in target vessel before registration (pre-dilation is allowed);

Key exclusion Criteria:

1. Left ventricular ejection fraction \< 40%；
2. NYHA class III or IV heart failure；
3. Patients with single coronary artery supply;
4. Patients with evidence of dissection at the site of the lesion on imaging;
5. 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;
6. Patients with active systemic infections;
7. Patients with uncontrollable severe hypertension (systolic pressure \> 180 mmHg or diastolic pressure \> 110 mmHg);
8. Patients with coagulopathy, hypercoagulable state or significant bleeding tendency (hemoglobin \<10g/dL or platelet count \<80×10\^9/L);

Where this trial is running

Beijing, Beijing Municipality

• Beijing Anzhen Hosipital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Principal investigator: XIANTAO SONG, Dortor — Beijing Anzhen Hosipital
• Study coordinator: XIANTAO SONG, Dortor

Conditions Coronary Arterial Disease; Calcification; Heart