SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI (SOLEMN)

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 Overview

• Status: Terminated
• Conditions: Percutaneous Coronary Intervention; Optical Coherence Tomography; In-stent Coronary Artery Restenosis
• Intervention / Treatment: Device: Optical Coherence Tomography

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 performed at the time of stent implantation.

Stent coverage in LM PCI will be studied with OCT at 3 and 12 months and compared to baseline OCT at the time of stent implantation.(31, 32)

OCT/data will be analyzed in a core lab (CTC CRF) and correlated with clinical outcomes at 3 and 12 months.

Primary Endpoint

• 3-month stent strut coverage in LM PCI

Secondary Endpoints

• 12-month stent strut coverage in LM PCI
• 3-month late acquired stent malapposition (LASM)
• 12-month late acquired stent malapposition (LASM)
• One-month LM Synergy stent safety
• 1-, 3- and 12-month MACE

• 1-, 3- and 12-month Stent Thrombosis (ST) (ARC definition)

  75 patients undergoing LM PCI (protected or unprotected) with Boston Scientific Synergy™ stent.

The goal is to enroll 75 patients from up to 10 VA sites and an enrollment period of 3 years, each site is expected to include 7-10 patients during the study period.

After a total of 75 patients are enrolled the study will be closed for further enrollment.

Eligible patients will be screened at each participating center and those who had undergone LM PCI with Boston Scientific Synergy™ stent and where OCT was performed during the index procedure will be eligible. The index procedure may be performed by any interventional cardiologist - this is specifically needed in order to maintain equipoise on the part of stent choice and use of OCT.

At the end of the study enrollment period, the proportion of patients at each site treated with Synergy stents vs. non-Synergy stents and the proportion of patients that underwent OCT imaging during LM PCI will be collected.

Eligible patients will be approached and consented for inclusion in the SOLEMN trial after the initial procedure.

Study Duration

Patients will be followed for 12 months after the index procedure. At one month, clinical follow-up will be performed (clinic or telephone). At 3 months, the angiography and OCT will be performed. At 12 months, the final angiography and OCT will be performed. No further follow-up is planned after completion of the 3- and 12-month angiography and OCT.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Birmingham VA Medical Center
  • Arizona
    • Tucson, Arizona, United States, 85723
      • Southern Arizona VA Health Care System
  • California
    • Long Beach, California, United States, 90822
      • VA Long Beach Healthcare
    • San Francisco, California, United States, 94121
      • San Francisco VA
  • Colorado
    • Denver, Colorado, United States, 80220
      • VA Eastern Colorado Health Care System
  • Georgia
    • Atlanta, Georgia, United States, 30033
      • Atlanta VA Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60025
      • Jesse Brown VAMC
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • VA Louis Stokes Cleveland VA Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma City VA Health Care System
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15240
      • VA Pittsburgh Healthcare System
  • South Carolina
    • Charleston, South Carolina, United States, 29401
      • Ralph H. Johnson VA Medical Center
  • Texas
    • Dallas, Texas, United States, 75216
      • Dallas VA Medical Center
    • San Antonio, Texas, United States, 78028
      • San Antonio VA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

  1. Bacteremia or sepsis
  2. Major coagulation system abnormalities
  3. Severe hemodynamic instability or shock
  4. Patients diagnosed with coronary artery spasm
  5. Acute renal failure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Optical Coherence Tomography; 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; 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.; Other Names: Dragonfly OPTIS Imaging Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Stents Analyzed for Strut Coverage in LM Percutaneous Coronary Intervention (PCI)	The stents from 2 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.	12 month
3-month Persistent Stent Malapposition	Malapposition is determined by measuring of the distance from the center of blooming to the nearby endoluminal surface of the intima. Malapposition is defined as a measured distance than the total thickness of the stent metal plus polymer of the stent (greater than 200 µm). Malapposition was considered persistent, since was already present at baseline.	3 month
12-month Persistent Stent Malapposition	Malapposition is determined by measuring of the distance from the center of blooming to the nearby endoluminal surface of the intima. Malapposition is defined as a measured distance than the total thickness of the stent metal plus polymer of the stent (greater than 200 µm). Malapposition was considered persistent, since was already present at baseline.	12 month
Major Adverse Cardiac Event (MACE)	MACE include: Death; Myocardial infarction; Stroke (cerebrovascular accident or CVA); Urgent revascularization; Repeat revascularization; Bleeding; Stent thrombosis; Rehospitalization	MACE reported at 12 months

Collaborators and Investigators

• Sponsor: Jesse Brown VA Medical Center
• Investigators: Principal Investigator: Mladen I Vidovich, MD, Jesse Brown VA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2018
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: March 14, 2018
• First Posted (Actual): March 22, 2018

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Stenosis; Coronary Restenosis
• Other Study ID Numbers: JBVA-MIV-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes