NCT06787547

Effectiveness and Safety of a Novel Intravascular Lithotripsy System in Severely Calcified Coronary Lesions(COCALP)

A Prospective, Multi-center, Single-arm, Objective Performance Goal Pre-specified Study to Evaluate the Safety and Effectiveness of Intravascular Lithotripsy Generator Combined with SONICO-CX Coronary Intravascular Lithotripsy (IVL) Catheter for Pre-treatment of Coronary Calcification Before Stent Implantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 266 (actual)
• Sponsor: Spectrumedics Medical Technology(Shanghai)Co.,Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multicenter, single-arm trial designed to investigate the effectiveness and safety of this intravascular lithotripsy system to treat severely calcified coronary lesions before stenting.

Detailed description

Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with stable, unstable or silent ischemia that are suitable for percutaneous coronary intervention (PCI). 266 subjects at 11 sites will be enrolled.Subjects will be followed through discharge, 30 days, 6months.

Conditions

• Calcified Coronary Lesions

Interventions

Type	Name	Description
DEVICE	IVL(Sonico-CX)	SONICO-CX® balloon matched 1:1 to the reference vessel diameter, was advanced to the target lesion to pretreat

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-11-29
• Completion: 2023-05-31
• First posted: 2025-01-22
• Last updated: 2025-01-22

Locations

11 sites across 1 country: China