Disrupt CAD III Post-Approval Study (PAS)

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05021757
• Other study ID #: CP 64647
• Status: Completed
• Start date: March 10, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: January 2024
• Source: Shockwave Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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®.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1212
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coronary Artery Disease
• Infarction
• Myocardial Infarction

Intervention

Device:
• Shockwave C2 Coronary IVL
PCI procedure using a Shockwave C2 coronary IVL catheter

Locations

Country	Name	City	State
United States	American College of Cardiology/National Cardiovascular Data Registry (NCDR)	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Shockwave Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause Death Rate		Up to hospital discharge, approximately 24-48 hours
Primary	Number of Participants With Procedure-related Adverse Events		Up to hospital discharge, approximately 24-48 hours
Primary	Number of Participants With IVL-related Ventricular Arrhythmia		Up to hospital discharge, approximately 24-48 hours
Primary	Number of Participants With IVL Balloon Loss of Pressure/Rupture		Up to hospital discharge, approximately 24-48 hours
Primary	Number of Participants With Serious Coronary Dissection Following Balloon Loss of Pressure/Rupture		Up to hospital discharge, approximately 24-48 hours
Primary	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