Status:
TERMINATED
SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI
Lead Sponsor:
Jesse Brown VA Medical Center
Conditions:
Percutaneous Coronary Intervention
Optical Coherence Tomography
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
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 performe...
Eligibility Criteria
Inclusion
- 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:
- Bacteremia or sepsis
- Major coagulation system abnormalities
- Severe hemodynamic instability or shock
- Patients diagnosed with coronary artery spasm
- Acute renal failure
Exclusion
Key Trial Info
Start Date :
July 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2020
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03474432
Start Date
July 11 2018
End Date
May 31 2020
Last Update
May 17 2024
Active Locations (13)
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1
Birmingham VA Medical Center
Birmingham, Alabama, United States, 35233
2
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
3
VA Long Beach Healthcare
Long Beach, California, United States, 90822
4
San Francisco VA
San Francisco, California, United States, 94121