SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI

Percutaneous Coronary Intervention Clinical Trial

— SOLEMN  

Official title:

SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03474432
• Other study ID #: JBVA-MIV-001
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: December 2019

Study information

• Verified date: January 2019
• Source: Jesse Brown VA Medical Center
• Contact: Mladen I Vidovich, MD
• Phone: 312-569-7099
• Email: mladen.vidovich[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Jesse Brown VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stent strut coverage in LM PCI	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.	3 Months
Secondary	12-month stent strut coverage in LM PCI	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.	12 month
Secondary	Late Acquired Stent Malapposition (LASM)	Malapposition will be defined as a measured distance greater than the total thickness of the stent metal plus polymer of the stent.	3 and 12 months
Secondary	Major Adverse Cardiac Event (MACE)	MACE include: Death; Myocardial infarction; Stroke (cerebrovascular accident or CVA); Urgent revascularization; Repeat revascularization; Bleeding; Stent thrombosis; Rehospitalization	1, 3 and 12 months