NCT06711822

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 205 (estimated)
• Sponsor: Keya Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 .

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.

Conditions

• Coronary Arterial Disease (CAD)
• Calcification; Heart

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-06-30
• Completion: 2025-12-30
• First posted: 2024-12-02
• Last updated: 2024-12-02

Locations

1 site across 1 country: China