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

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ClinicalTrials.gov Identifier: NCT03474432
Recruitment Status : Recruiting
First Posted : March 22, 2018
Last Update Posted : January 16, 2019
Sponsor:
Information provided by (Responsible Party):
Mladen I. Vidovich, Jesse Brown VA Medical Center

Tracking Information
First Submitted Date  ICMJE March 2, 2018
First Posted Date  ICMJE March 22, 2018
Last Update Posted Date January 16, 2019
Actual Study Start Date  ICMJE June 15, 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2018)
Stent strut coverage in LM PCI [ Time Frame: 3 Months ]
The stent strut coverage 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03474432 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2018)
  • 12-month stent strut coverage in LM PCI [ Time Frame: 12 month ]
    The stent strut coverage 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.
  • Late Acquired Stent Malapposition (LASM) [ Time Frame: 3 and 12 months ]
    Malapposition will be defined as a measured distance greater than the total thickness of the stent metal plus polymer of the stent.
  • Major Adverse Cardiac Event (MACE) [ Time Frame: 1, 3 and 12 months ]
    MACE include:
    • Death
    • Myocardial infarction
    • Stroke (cerebrovascular accident or CVA)
    • Urgent revascularization
    • Repeat revascularization
    • Bleeding
    • Stent thrombosis
    • Rehospitalization
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI
Official Title  ICMJE SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Percutaneous Coronary Intervention
  • Optical Coherence Tomography
  • In-stent Coronary Artery Restenosis
Intervention  ICMJE 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 Name: Dragonfly OPTIS Imaging Catheter
Study Arms  ICMJE 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.
Intervention: Device: Optical Coherence Tomography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2018)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mladen I Vidovich, MD 312-569-7099 mladen.vidovich@va.gov
Contact: Decebal Griza, MD 312-569-6129 Decebal.Griza@va.gov
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03474432
Other Study ID Numbers  ICMJE JBVA-MIV-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mladen I. Vidovich, Jesse Brown VA Medical Center
Study Sponsor  ICMJE Jesse Brown VA Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mladen I Vidovich, MD Jesse Brown VA Medical Center
PRS Account Jesse Brown VA Medical Center
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP