SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI
Public ClinicalTrials.gov record NCT03474432. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03474432
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 12 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 10, 2018
- Primary completion
- Dec 30, 2019
- Completion
- May 30, 2020
- Last update posted
- May 16, 2024
2018 – 2020
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Birmingham VA Medical Center | Birmingham | Alabama | 35233 | — |
| Southern Arizona VA Health Care System | Tucson | Arizona | 85723 | — |
| VA Long Beach Healthcare | Long Beach | California | 90822 | — |
| San Francisco VA | San Francisco | California | 94121 | — |
| VA Eastern Colorado Health Care System | Denver | Colorado | 80220 | — |
| Atlanta VA Medical Center | Atlanta | Georgia | 30033 | — |
| Jesse Brown VAMC | Chicago | Illinois | 60025 | — |
| VA Louis Stokes Cleveland VA Medical Center | Cleveland | Ohio | 44106 | — |
| Oklahoma City VA Health Care System | Oklahoma City | Oklahoma | 73104 | — |
| VA Pittsburgh Healthcare System | Pittsburgh | Pennsylvania | 15240 | — |
| Ralph H. Johnson VA Medical Center | Charleston | South Carolina | 29401 | — |
| Dallas VA Medical Center | Dallas | Texas | 75216 | — |
| San Antonio VA | San Antonio | Texas | 78028 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03474432, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 16, 2024 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03474432 live on ClinicalTrials.gov.