SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI

NCT03474432 | Terminated Results DMC FDA Device

• 1 other identifier: JBVA-MIV-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 13

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 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.

Conditions

Percutaneous Coronary Intervention; Optical Coherence Tomography; In-stent Coronary Artery Restenosis

Outcome Measures

Primary Outcomes (1)

• The Stents Analyzed for Strut Coverage in LM Percutaneous Coronary Intervention (PCI)

  The stents from 6 participants were analyzed for strut coverage, which is specifically defined as Percentage of Uncovered Stent Struts. The Percentage of Uncovered Stent Struts is the number of struts without distinct overlying tissue, in which the luminal reflection of the strut surface is directly interfacing with the lumen, divided by total number of analyzable struts.

  3 Months

Secondary Outcomes (4)

• The Stents Analyzed for Strut Coverage in LM Percutaneous Coronary Intervention (PCI)

  12 month

• 3-month Persistent Stent Malapposition

  3 month

• 12-month Persistent Stent Malapposition

  12 month

• Major Adverse Cardiac Event (MACE)

  MACE reported at 12 months

Study Arms (1)

Optical Coherence Tomography

OTHER

Patients who have undergone clinically-indicated PCI of LM where OCT was performed as part of the routine index procedure will be approached for the study and enrolled if eligible.

Device: Optical Coherence Tomography

Interventions

Optical Coherence Tomography DEVICE

OCT will be performed with the St. Jude OCT system. Detection of metallic stent struts will be performed automatically with manual adjustments made as necessary. Stent area tracings will be automatically performed by interpolated contours connecting the center point of the luminal surface of each detected metallic strut. Stent expansion will be determined as the minimum stent area divided by the average reference lumen area and presented as a percentage. Neo-intimal hyperplasia (NIH) area will be determined in follow-up examinations as the area between the stent and lumen contours. Incomplete stent apposition (ISA) area will be determined as the area between the stent contour and the lumen contour at the site of malapposed struts, in a region not overlying a side branch ostium.

Also known as: Dragonfly OPTIS Imaging Catheter

Optical Coherence Tomography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Jesse Brown VA Medical Center: lead

Study Sites (13)

Birmingham VA Medical Center

Birmingham, Alabama, 35233, United States

Location

Southern Arizona VA Health Care System

Tucson, Arizona, 85723, United States

Location

VA Long Beach Healthcare

Long Beach, California, 90822, United States

Location

San Francisco VA

San Francisco, California, 94121, United States

Location

VA Eastern Colorado Health Care System

Denver, Colorado, 80220, United States

Location

Atlanta VA Medical Center

Atlanta, Georgia, 30033, United States

Location

Jesse Brown VAMC

Chicago, Illinois, 60025, United States

Location

VA Louis Stokes Cleveland VA Medical Center

Cleveland, Ohio, 44106, United States

Location

Oklahoma City VA Health Care System

Oklahoma City, Oklahoma, 73104, United States

Location

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

Location

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, 29401, United States

Location

Dallas VA Medical Center

Dallas, Texas, 75216, United States

Location

San Antonio VA

San Antonio, Texas, 78028, United States

Location

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Results Point of Contact

• Title: Dr. Mladen Vidovich, study PI
• Organization: Jesse Brown VAMC

miv@uic.edu

312-996-6730

Study Officials

• Mladen I Vidovich, MD

  Jesse Brown VA Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, University of Illinois at Chicago and Chief of Cardiology, Jesse Brown VA Medical Center

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 22, 2018
• Study Start: July 11, 2018
• Primary Completion: December 31, 2019
• Study Completion: May 31, 2020
• Last Updated: May 17, 2024
• Results First Posted: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)