Baylor Scott & White Heart & Vascular Hospital – Dallas is currently enrolling patients for a prospective, multicenter, single-arm, global investigational device exemption (IDE) study to evaluate the safety and effectiveness of the Shockwave Coronary IVL System in de novo, calcified, stenotic coronary arteries prior to stenting. Disrupt CAD III is being conducted as a staged pivotal study.
The Heart & Vascular Hospital in Dallas is one of just two sites in Texas approved to participate in this study. Data generated from this study will be part of any evaluation around the use of coronary IVL in the United States by the FDA.
Primary outcomes measures for the trial include:
- Total number of participants with treatment and device related adverse events within 30 days of index procedure. *Adverse Events must meet definition of (MACE) Major Adverse Cardiac Events
- Total number of participants that had a successful index procedure and without in-hospital MACE at the end of the procedure. *Successful procedure is defined as delivering lithotripsy to the target vessel and placing a coronary stent with residual stenosis of less than 50% (Core lab assessed) and without in-hospital MACE.
A summary of eligibility criteria are included below. For a complete list of eligibility criteria and outcomes measures, visit: ClinicalTrials.gov. (Study NCT#: NCT03595176).
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
- For patients with unstable ischemic heart disease, biomarkers (troponin or CK-MB) must be less than or equal to the upper limit of lab normal within 12 hours prior to the procedure (note: if both labs are drawn, both must be normal).
Exclusion Criteria:
- Any comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
- Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint
- New York Heart Association (NYHA) class III or IV heart failure