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Post-market clinical evaluation of the Gentuity High-Frequency Optical Coherence Tomography (HF-OCT) System and the Vis-Rx Micro-Imaging Catheter for use in Percutaneous Coronary Intervention (PCI) procedures.
Full description
Prospective, single-arm, unblinded, multi-center, post-market clinical evaluation assessing the imaging capabilities of the Gentuity HF-OCT System and the Vis-Rx Micro-Imaging Catheter for use in PCI procedures. Objectives are to evaluate the clinical and technical performance in the target patient population.
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Inclusion and exclusion criteria
Inclusion Criteria:
General Exclusion Criteria:
Lesion-Specific Exclusion Criteria:
75 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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