NCT05021757

Disrupt CAD III Post-Approval Study (PAS)

New Enrollment Post Approval Registry for the Shockwave Intravascular Lithotripsy (IVL) System With Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,212 (actual)
• Sponsor: Shockwave Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study design is a prospective, multicenter, observational, single-arm post-approval study using data collected in the National Cardiovascular Data Registry (NCDR®) CathPCI Registry®.

Detailed description

Subject Population: Patients ≥18 years of age with severely calcified, stenotic de novo coronary artery lesions presenting with stable, unstable, or silent ischemia that are suitable for percutaneous coronary intervention (PCI) and with clinical characteristics similar to the Disrupt CAD III IDE study. Approximately 1000 patients in the CathPCI Registry® (including a minimum of 30 patients with permanent pacemakers \[PPM\] or implantable cardioverter defibrillators \[ICDs\]) will be enrolled. Subjects will be followed through discharge.

Conditions

• Coronary Artery Disease
• Myocardial Infarction

Interventions

Type	Name	Description
DEVICE	Shockwave C2 Coronary IVL	PCI procedure using a Shockwave C2 coronary IVL catheter

Timeline

• Start date: 2021-03-10
• Primary completion: 2022-03-31
• Completion: 2022-03-31
• First posted: 2021-08-25
• Last updated: 2024-02-01
• Results posted: 2024-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study