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Clinical trialNCT03474432TerminatedInterventional

SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI

SponsorJesse Brown VA Medical CenterEnrollment12In-stent Coronary Artery RestenosisOptical Coherence TomographyPercutaneous Coronary Intervention
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

13 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • 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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
11 Jul 2018
Primary completion
31 Dec 2019
Completion
31 May 2020
Last update posted
17 May 2024
Registered enrollment
12
Registry id
NCT03474432

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.