Disrupt CAD III Post-Approval Study (PAS)

  • STATUS
    Recruiting
  • End date
    Jul 24, 2023
  • participants needed
    1000
  • sponsor
    Shockwave Medical, Inc.
Updated on 24 May 2022
angiography
stenosis
unstable angina
ischemia
exercise stress test

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. A minimum of 150 patients will be followed 30 days post-procedure.

Details
Condition Coronary Artery Disease, Myocardial Infarction
Treatment Shockwave C2 Coronary IVL
Clinical Study IdentifierNCT05021757
SponsorShockwave Medical, Inc.
Last Modified on24 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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