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

NCT06711822 | Recruiting

• 1 other identifier: 2024-27
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

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 .

Conditions

Coronary Arterial Disease (CAD); Calcification; Heart

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Device

EXPERIMENTAL

Shockplus-10

Device: Shockplus-10

Interventions

Shockplus-10 DEVICE

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

Device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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);

Sponsors & Collaborators

• Keya Medical: lead

Study Sites (1)

Beijing Anzhen Hosipital

Beijing, Beijing Municipality, 010, China

RECRUITING

MeSH Terms

Conditions

Calcinosis

Condition Hierarchy (Ancestors)

Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• XIANTAO SONG, Dortor

  Beijing Anzhen Hosipital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

XIANTAO SONG, Dortor

CONTACT

010-64412431; Song0929@mail.ccmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: December 2, 2024
• Study Start: July 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)