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Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as RVD of 2.00 mm to 2.75 mm, in support of a PMA application to the FDA. Subjects who present with CCS, unstable angina or stabilized NSTEMI with an indication for PCI with planned intervention for de novo lesions in small coronary vessels will be randomized 1:1 to treatment of the identified target lesion with either the SELUTION SLR 014 PTCA DEB or contemporary DES.
Current Enrollment: 12 consented, 9 screen failures, and 3 enrolled.
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