Disrupt CAD III Post-Approval Study (PAS)

NCT05021757 | Completed Results FDA Device

• 1 other identifier: CP 64647
• Study Type: observational
• Target: 1,212
• Locations: 1 country
• Sites: 1

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®.

Conditions

Coronary Artery Disease; Myocardial Infarction

Keywords

Intravascular Lithotripsy; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

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

Interventions

Shockwave C2 Coronary IVL DEVICE

PCI procedure using a Shockwave C2 coronary IVL catheter

Disrupt CAD III PAS Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subject is ≥18 years of age
• Subjects with native coronary artery disease (including stable or unstable angina and silent ischemia) suitable for PCI
• Left ventricular ejection fraction \>25% within 6 months
• The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure
• 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
• The lesion length must not exceed 40 mm
• The target vessel must have TIMI flow 3 at baseline (visually assessed; may be assessed after pre-dilatation)
• 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

You may not qualify if:

• Subject experienced an acute MI (STEMI or non-STEMI) within 30 days prior to index procedure
• New York Heart Association (NYHA) class III or IV heart failure
• Renal failure with serum creatinine \>2.5 mg/dL or chronic dialysis
• Subjects in cardiogenic shock or with clinical evidence of acute heart failure
• Target lesion is located in a native vessel that can only be reached by going through a saphenous vein or arterial bypass graft
• Previous stent within target lesion (in-stent restenosis)

Sponsors & Collaborators

• Shockwave Medical, Inc.: lead

Study Sites (1)

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

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Results Point of Contact

• Title: Randee Randoll
• Organization: Shockwave Medical

rrandoll@shockwavemedical.com

408.577.7856

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 25, 2021
• Study Start: March 10, 2021
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: February 1, 2024
• Results First Posted: February 1, 2024

Record last verified: 2024-01

Locations

US (1)