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.

Inclusion criteria:

- Age 18 years or greater;

- Left Main CAD, defined as ≥ 50% diameter stenosis and amenable to re-vascularization
by PCI;

- Willing and able to give informed consent. The patients must be able to comply with
study procedures and follow-up.

- Ability to comply with minimum of 6 months of DAPT after the index procedure.

- Unprotected Left Main PCI

- Protected Left Main PCI

Exclusion criteria:

- Coexisting conditions that limit life expectancy to less than 12 months or that could
affect patient's compliance with the protocol;

- Serum creatinine greater than 2.0 mg/dL;

- Cardiogenic shock;

- STEMI;

- Non-STEMI, if the cardiac troponin is not stable or starting to decline;

- Pregnancy;

- Inability to take dual antiplatelet therapy for 6 months;

- Any target lesion with previously placed stent.

- Patients disqualified for CABG surgery.

- Contraindications for OCT use:

1. Bacteremia or sepsis

2. Major coagulation system abnormalities

3. Severe hemodynamic instability or shock

4. Patients diagnosed with coronary artery spasm

5. Acute renal failure