SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI

The proposed study is a multicenter, observational, prospective, single-arm study of stent strut coverage of patients undergoing LM PCI. Baseline quantitative coronary analysis (QCA) will be performed at the time of stent implantation. Stent coverage in LM PCI will be studied with OCT at 3 and 12 months and compared to baseline OCT at the time of stent implantation.(31, 32) OCT/data will be analyzed in a core lab (CTC CRF) and correlated with clinical outcomes at 3 and 12 months. Primary Endpoint • 3-month stent strut coverage in LM PCI Secondary Endpoints * 12-month stent strut coverage in LM PCI * 3-month late acquired stent malapposition (LASM) * 12-month late acquired stent malapposition (LASM) * One-month LM Synergy stent safety * 1-, 3- and 12-month MACE * 1-, 3- and 12-month Stent Thrombosis (ST) (ARC definition) 75 patients undergoing LM PCI (protected or unprotected) with Boston Scientific Synergy™ stent. The goal is to enroll 75 patients from up to 10 VA sites and an enrollment period of 3 years, each site is expected to include 7-10 patients during the study period. After a total of 75 patients are enrolled the study will be closed for further enrollment. Eligible patients will be screened at each participating center and those who had undergone LM PCI with Boston Scientific Synergy™ stent and where OCT was performed during the index procedure will be eligible. The index procedure may be performed by any interventional cardiologist - this is specifically needed in order to maintain equipoise on the part of stent choice and use of OCT. At the end of the study enrollment period, the proportion of patients at each site treated with Synergy stents vs. non-Synergy stents and the proportion of patients that underwent OCT imaging during LM PCI will be collected. Eligible patients will be approached and consented for inclusion in the SOLEMN trial after the initial procedure. Study Duration Patients will be followed for 12 months after the index procedure. At one month, clinical follow-up will be performed (clinic or telephone). At 3 months, the angiography and OCT will be performed. At 12 months, the final angiography and OCT will be performed. No further follow-up is planned after completion of the 3- and 12-month angiography and OCT.