This trial will evaluate Orbital Atherectomy compared to conventional balloon angioplasty technique for the treatment of severely calcified lesions prior to implantation of drug-eluting stents (DES).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,005
Vessel preparation with Orbital Atherectomy followed by balloon pre-dilatation
Vessel preparation with conventional and/or specialty balloons
Acute Minimum Stent Area (MSA)
In-stent minimal cross-sectional area as assessed by optical coherence tomography (OCT) at the conclusion of the procedure in the OCT imaging cohort.
Time frame: Procedure
Target Vessel Failure (TVF)
Target vessel failure, defined as the composite of cardiac death, target vessel related myocardial infarction (MI), or ischemia-driven target vessel revascularization.
Time frame: 1-Year
Procedural Success
Procedural success, defined as successful stent delivery with final Core Lab defined Thrombolysis in Myocardial Infarction (TIMI) flow three (3) and angiographic in-stent diameter stenosis (DS) ≤20%, and with the absence of any of the following: stent loss, coronary perforation, or intra-procedural death.
Time frame: Procedure
Strategy Success
Strategy success, defined as procedural success without crossover to alternative treatment.
Time frame: Procedure
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University of Alabama - Birmingham
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Arkansas Heart Hospital
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University of California - San Diego
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Ronald Reagan UCLA Medical Center
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San Francisco VA Medical Center
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...and 94 more locations