Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE)
(MACE Trial)

Recruiting in Palo Alto (17 mi)

+33 other locations

Overseen bySamin K Sharma, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Cardiovascular Systems Inc

No Placebo Group

Trial Summary

What is the purpose of this trial?

The objective of this study is to assess the current standard of care treatment outcome in none/mild, moderate and severely calcified coronary lesions using: * A composite of MACE at 30-day and one (1) year post procedure, and * Procedural and lesion success

Eligibility Criteria

Inclusion Criteria

Subjects must be at least 18 years of age.

Subjects must be scheduled for percutaneous coronary revascularization involving stent deployment in de novo coronary lesions. Percutaneous coronary revascularization is defined as treatment with commercially available devices that may include but not limited to balloon angioplasty, cutting balloon, rotablation, etc. followed by the stent placement.

Subjects CK-MB must be less than or equal to the upper limit of lab normal value within eight (8) hours prior to procedure. If CK-MB results are not yet available prior to initiating procedure, subjects Troponin I or Troponin T must be less than or equal to the upper limit of lab normal value within eight (8) hours prior to the procedure.

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Treatment Details

Interventions

Percutaneous Coronary Intervention (Procedure)

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Severe calcificationExperimental Treatment1 Intervention

Presence of radiopacities noted without cardiac motion prior to contrast injection involving both sides of the arterial wall in at least one location, total length of calcium (including segmented) must be at least 15mm and extend partially into the target lesion.

Group II: None/mild calcificationExperimental Treatment1 Intervention

Presence of readily apparent radiopacities within the vascular wall at the site of the stenosis.

Group III: Moderate CalcificationExperimental Treatment1 Intervention

Presence of radiopacities only during the cardiac cycle before contrast injection with calcium extended partially into the target lesion.