Clinical trial NCT05021757: Disrupt CAD III Post-Approval Study (PAS)
Official title: New Enrollment Post Approval Registry for the Shockwave Intravascular Lithotripsy (IVL) System With Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Myocardial Infarction
Keywords: Intravascular Lithotripsy
Percutaneous Coronary Intervention
Lead sponsor: Shockwave Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-25
Enrollment: 1212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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)

Primary outcomes:
measure: All-cause Death Rate
timeFrame: Up to hospital discharge, approximately 24-48 hours
measure: Number of Participants With Procedure-related Adverse Events
timeFrame: Up to hospital discharge, approximately 24-48 hours
measure: Number of Participants With IVL-related Ventricular Arrhythmia
timeFrame: Up to hospital discharge, approximately 24-48 hours
measure: Number of Participants With IVL Balloon Loss of Pressure/Rupture
timeFrame: Up to hospital discharge, approximately 24-48 hours
measure: Number of Participants With Serious Coronary Dissection Following Balloon Loss of Pressure/Rupture
timeFrame: Up to hospital discharge, approximately 24-48 hours
measure: Number of IVL-related Pacing Issues in Patients With PPM/ICD
timeFrame: Up to hospital discharge, approximately 24-48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: American College of Cardiology/National Cardiovascular Data Registry (NCDR)
state: District of Columbia
Study officials:
References: