Disrupt CAD III Post-Approval Study (PAS)

NCT ID: NCT05021757

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1212 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-10
• Study Completion Date: 2022-03-31

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Disrupt CAD III PAS Cohort

Patients in the CathPCI Registry who undergo a PCI procedure using a Shockwave C2 Coronary IVL catheter and meeting the eligibility criteria will be included in the PAS cohort.

Shockwave C2 Coronary IVL

Intervention Type: DEVICE

PCI procedure using a Shockwave C2 coronary IVL catheter

Interventions

Shockwave C2 Coronary IVL

PCI procedure using a Shockwave C2 coronary IVL catheter

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject is ≥18 years of age

2. Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI

3. Left ventricular ejection fraction >25% within 6 months

4. The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure

5. LAD, RCA or LCX (or of their branches) with:

• Stenosis of ≥70% and <100% or
• Stenosis ≥50% and <99% (visually assessed) with evidence of ischemia via positive stress test, or fractional flow reserve (FFR) value ≤0.80, or iFR <0.90 or IVUS or OCT minimum lumen area ≤4.0 mm²

6. The lesion length must not exceed 40 mm

7. The target vessel must have TIMI flow 3 at baseline (visually assessed; may be assessed after pre-dilatation)

8. Evidence of calcification at the lesion site by angiography, with fluoroscopic radio-opacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location

Exclusion Criteria

1. Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure

2. New York Heart Association (NYHA) class III or IV heart failure

3. Renal failure with serum creatinine >2.5 mg/dL or chronic dialysis

4. Subjects in cardiogenic shock or with clinical evidence of acute heart failure

5. Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft

6. Previous stent within target lesion (in-stent restenosis)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shockwave Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

American College of Cardiology/National Cardiovascular Data Registry (NCDR)

Washington D.C., District of Columbia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CP 64647

Identifier Type: -

Identifier Source: org_study_id