NCT03595176

Disrupt CAD III With the Shockwave Coronary IVL System

Prospective, Multicenter, Single-Arm, Global IDE Study of the Shockwave Coronary Intravascular Lithotripsy (IVL) System With the Shockwave C2 Coronary IVL Catheter in Calcified Coronary Arteries

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 431 (actual)
• Sponsor: Shockwave Medical, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The study design is a prospective, multicenter, single-arm, global IDE study to evaluate the safety and effectiveness of the Shockwave Medical Coronary Intravascular Lithotripsy (IVL) System in de novo, calcified, stenotic coronary arteries prior to stenting. Disrupt CAD III is being conducted as a staged pivotal study.

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). Approximately 392 subjects at 50 sites will be enrolled. A minimum of 50% of the total enrollment will come from the United States.Subjects will be followed through discharge, 30 days, 6, 12 and 24 months.

Conditions

• Coronary Artery Disease
• Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	Lithotripsy	Deliver Lithotripsy to the target vessel prior to placing a coronary stent.

Timeline

• Start date: 2019-01-09
• Primary completion: 2020-05-07
• Completion: 2022-04-10
• First posted: 2018-07-23
• Last updated: 2023-05-19
• Results posted: 2021-06-21

Locations

48 sites across 4 countries: United States, France, Germany, United Kingdom

Regulatory

• FDA-regulated device study