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

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 .

Study Overview

• Status: Recruiting
• Conditions: Calcification; Heart; Coronary Arterial Disease (CAD)
• Intervention / Treatment: Device: Shockplus-10

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.

• Study Type: Interventional
• Enrollment (Estimated): 205
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: XIANTAO SONG, Dortor; Phone Number: 010-64412431; Email: Song0929@mail.ccmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 010
      • Recruiting
      • Beijing Anzhen Hosipital
      • Contact: Yanlong REN, Dortor; Phone Number: 010-84005400

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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);

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device; Shockplus-10	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure success	Procedure success defined as successful stent implantation, residual stenosis degree ≤30% , and no major adverse cardiac events (MACE) occurring during hospitalization	immediately post-procedure or prior to discharge, whichever comes first
Freedom from major adverse cardiac events (MACE) within 30 days of the 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	30（±7days）days post index procedure

Collaborators and Investigators

• Sponsor: Keya Medical
• Investigators: Principal Investigator: XIANTAO SONG, Dortor, Beijing Anzhen Hosipital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: November 27, 2024
• First Posted (Estimated): December 2, 2024

Study Record Updates

• Last Update Posted (Estimated): December 2, 2024
• Last Update Submitted That Met QC Criteria: November 27, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Calcium Metabolism Disorders; Calcinosis
• Other Study ID Numbers: 2024-27

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No