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

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®.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Coronary Artery Disease
• Intervention / Treatment: Device: Shockwave C2 Coronary IVL

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.

• Study Type: Observational
• Enrollment (Actual): 1212

Contacts and Locations

• Study Contact: Name: Randee Randoll; Phone Number: 408-577-7856; Email: rrandoll@shockwavemedical.com

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • American College of Cardiology/National Cardiovascular Data Registry (NCDR)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients 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.

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Shockwave C2 Coronary IVL; PCI procedure using a Shockwave C2 coronary IVL catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause Death Rate		Up to hospital discharge, approximately 24-48 hours
Number of Participants With Procedure-related Adverse Events		Up to hospital discharge, approximately 24-48 hours
Number of Participants With IVL-related Ventricular Arrhythmia		Up to hospital discharge, approximately 24-48 hours
Number of Participants With IVL Balloon Loss of Pressure/Rupture		Up to hospital discharge, approximately 24-48 hours
Number of Participants With Serious Coronary Dissection Following Balloon Loss of Pressure/Rupture		Up to hospital discharge, approximately 24-48 hours
Number of IVL-related Pacing Issues in Patients With PPM/ICD	Events that may indicate an adverse device interaction including inappropriate inhibition of pacing during IVL device utilization, inappropriate ICD shock during IVL device utilization (for ICD patients only), and the need for device re-programming associated with IVL use (during or post procedure).	Up to hospital discharge, approximately 24-48 hours

Collaborators and Investigators

• Sponsor: Shockwave Medical, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2021
• Primary Completion (Actual): March 31, 2022
• Study Completion (Actual): March 31, 2022

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Actual): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Intravascular Lithotripsy
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Coronary Artery Disease
• Other Study ID Numbers: CP 64647

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes