SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI

Not Applicable

Terminated

Conditions: In-stent Coronary Artery Restenosis
Optical Coherence Tomography
Percutaneous Coronary Intervention

Interventions: Device: Optical Coherence Tomography

Registration Number: NCT03474432

Lead Sponsor: Jesse Brown VA Medical Center

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optical Coherence Tomography	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.

Primary Outcome Measures

Name	Time	Method
The Stents Analyzed for Strut Coverage in LM Percutaneous Coronary Intervention (PCI)	3 Months	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.

Secondary Outcome Measures

Name	Time	Method
The Stents Analyzed for Strut Coverage in LM Percutaneous Coronary Intervention (PCI)	12 month	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 Persistent Stent Malapposition	12 month	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.
Major Adverse Cardiac Event (MACE)	MACE reported at 12 months	MACE include: * Death * Myocardial infarction * Stroke (cerebrovascular accident or CVA) * Urgent revascularization * Repeat revascularization * Bleeding * Stent thrombosis * Rehospitalization
3-month Persistent Stent Malapposition	3 month	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.

Trial Locations

Locations (13): Atlanta VA Medical Center
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Atlanta, Georgia, United States
VA Pittsburgh Healthcare System
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Pittsburgh, Pennsylvania, United States
Ralph H. Johnson VA Medical Center
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Charleston, South Carolina, United States
Southern Arizona VA Health Care System
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Tucson, Arizona, United States
Birmingham VA Medical Center
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Birmingham, Alabama, United States
San Francisco VA
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San Francisco, California, United States
VA Eastern Colorado Health Care System
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Denver, Colorado, United States
VA Louis Stokes Cleveland VA Medical Center
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Cleveland, Ohio, United States
Oklahoma City VA Health Care System
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Oklahoma City, Oklahoma, United States
San Antonio VA
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San Antonio, Texas, United States
VA Long Beach Healthcare
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Long Beach, California, United States
Jesse Brown VAMC
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Chicago, Illinois, United States
Dallas VA Medical Center
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Dallas, Texas, United States