SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI
Stopped early · Not applicable
Conditions studied: Percutaneous Coronary Intervention, Optical Coherence Tomography, In-stent Coronary Artery Restenosis
In brief
BACKGROUD: Percutaneous coronary intervention (PCI) is increasingly used to treat unprotected left main coronary artery stenosis. Protected LM PCI is considered standard of care in most centers. OCT allows for precise determination of stent placement, stent expansion and apposition. The pattern of vessel healing can be very precisely studied if immediate post-stent implantation OCT/IVUS data is compared to the 6-month post-PCI interval. While OCT cannot be optimally used for ostial lesion imaging, IVUS can be used to image ostial lesions/stent placement. Optimal and consistent vessel healing is particularly important in LM PCI where stent thrombosis is a potential complication with serious adverse outcome. HYPOTHESIS: Due to the absorption of the polymer of the Boston Scientific Synergy Stent over time, early strut coverage patterns and timeline may be different than previously observed in DES and BMS stents in LM PCI. Late acquired stent malapposition (LASM) is expected to differ from previous observations with traditional DES/BMS. Stent coverage in LM PCI will be studied with OCT or IVUS at six and 12 months and compared to OCT or IVUS at the time of stent implantation. OCT/IVUS data will be analyzed in a core lab (CRF) and correlated with clinical outcomes at 6 and 12 months.
Key facts
- Study ID
- NCT03474432
- Run by
- Jesse Brown VA Medical Center
- People needed
- 12
- Starts
- 2018-07-11
- Expected to finish
- 2020-05-31
- Last updated by the study team
- 2024-05-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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:
- Bacteremia or sepsis
- Major coagulation system abnormalities
- Severe hemodynamic instability or shock
- Patients diagnosed with coronary artery spasm
- Acute renal failure
Where it is running
- Birmingham VA Medical Center — Birmingham, Alabama, United States
- Southern Arizona VA Health Care System — Tucson, Arizona, United States
- VA Long Beach Healthcare — Long Beach, California, United States
- San Francisco VA — San Francisco, California, United States
- VA Eastern Colorado Health Care System — Denver, Colorado, United States
- Atlanta VA Medical Center — Atlanta, Georgia, United States
- Jesse Brown VAMC — Chicago, Illinois, United States
- VA Louis Stokes Cleveland VA Medical Center — Cleveland, Ohio, United States
- Oklahoma City VA Health Care System — Oklahoma City, Oklahoma, United States
- VA Pittsburgh Healthcare System — Pittsburgh, Pennsylvania, United States
- Ralph H. Johnson VA Medical Center — Charleston, South Carolina, United States
- Dallas VA Medical Center — Dallas, Texas, United States
- San Antonio VA — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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