Clinical trial NCT03474432: SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI
Official title: SOLEMN Study - Synergy Optical Coherence Tomography in Left Main PCI
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Percutaneous Coronary Intervention
Optical Coherence Tomography
In-stent Coronary Artery Restenosis
Lead sponsor: Jesse Brown VA Medical Center
Sponsor class: FED
First posted: 2018-03-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Stents Analyzed for Strut Coverage in LM Percutaneous Coronary Intervention (PCI)
timeFrame: 3 Months
Secondary outcomes:
measure: The Stents Analyzed for Strut Coverage in LM Percutaneous Coronary Intervention (PCI)
timeFrame: 12 month
measure: 3-month Persistent Stent Malapposition
timeFrame: 3 month
measure: 12-month Persistent Stent Malapposition
timeFrame: 12 month
measure: Major Adverse Cardiac Event (MACE)
timeFrame: MACE reported at 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham VA Medical Center
state: Alabama
city: Tucson
country: United States
facility: Southern Arizona VA Health Care System
state: Arizona
city: Long Beach
country: United States
facility: VA Long Beach Healthcare
state: California
city: San Francisco
country: United States
facility: San Francisco VA
state: California
city: Denver
country: United States
facility: VA Eastern Colorado Health Care System
state: Colorado
city: Atlanta
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Chicago
country: United States
facility: Jesse Brown VAMC
state: Illinois
city: Cleveland
country: United States
facility: VA Louis Stokes Cleveland VA Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma City VA Health Care System
state: Oklahoma
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center
state: South Carolina
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: San Antonio
country: United States
facility: San Antonio VA
state: Texas
Study officials:
affiliation: Jesse Brown VA Medical Center
name: Mladen I Vidovich, MD
role: PRINCIPAL_INVESTIGATOR
References: