Clinical trial NCT03401216: StEnt Coverage and Neointimal Tissue Characterization After eXtra Long evErolimus - Eluting Stent imPlantation
Official title: StEnt Coverage and Neointimal Tissue Characterization After eXtra Long evErolimus - Eluting Stent imPlantation: Prospective sTudy Using optIcal cOhereNce Tomography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Heart Disease
Coronary Artery Disease
Coronary Atherosclerosis
Keywords: Optical coherence tomography
Healing score
Neointimal coverage
synergy 48
long lesion
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
Collaborators: name: Boston Scientific Corporation
First posted: 2018-01-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 80 patients, that underwent PCI with Synergy 48 mm stent implantation, will be randomized into 2 groups of follow-up OCT-visualization - 3 and 6 month.
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the rate of SYNERGY 48 mm stent strut coverage and assess neointimal progression via OCT measurement in patients who underwent PCI.

Detailed description: Patients with stable, unstable angina and non-ST-elevation ACS will be included in this study. Patient will undergo coronary angiography for coronary anatomy assessment and estimation indications for PCI . After screening an OCT-guided PCI with extra long SYNERGY stent implantation will be provided in all patients. Patient will be divided into 2 groups of follow-up and will be followed within 3 and 6 month after procedure. Final clinical follow-up will be assessed at 12 month for all patients. At each follow-up visits the data regarding clinical events, coronary angiography and OCT-imaging will be collected.

Eligibility criteria: Inclusion Criteria:

* Signed written informed consent before study procedures
* Subject is eligible for percutaneous coronary intervention (PCI)
* Left ventricular ejection fraction (LVEF) \>30%
* Reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm
* Target lesion(s) length must be ≥38 mm
* Target lesion(s) stenosis ≥50%

Exclusion Criteria:

* History of acute or recent stroke (\<2 months)
* Contraindications for antiplatelet and/or anticoagulant therapy
* Bleeding within the last 30 days
* Subject has acute ST elevation MI (STEMI)
* Subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support
* Subject with out of range complete blood count (CBC) values determined as a clinically significant
* Subject has documented or suspected liver disease, including laboratory evidence of hepatitis
* Subject has baseline serum creatinine level \>2.0 mg/dL (177µmol/L)
* Subject has signs or symptoms of active heart failure (i.e., NYHA class IV) at the time of the index procedure
* Subject is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)
* Lesion located within a saphenous vein graft or an arterial graft
* Subject has unprotected left main coronary artery disease (\>50% diameter stenosis)
* Other serious medical illness (e.g., cancer, congestive heart failure) that may reduce life expectancy to less than 12 months

Primary outcomes:
measure: Neointimal healing score
timeFrame: within 3 month after PCI
measure: Neointimal healing score
timeFrame: within 6 month after PCI
Secondary outcomes:
measure: Percentage of strut coverage assessed by OCT
timeFrame: within 3 month after PCI
measure: Percentage of strut coverage assessed by OCT
timeFrame: within 6 month after PCI
measure: Percentage of mature neointimal tissue assessed by OCT
timeFrame: within 3 month after PCI
measure: Percentage of mature neointimal tissue assessed by OCT
timeFrame: within 6 month after PCI
Other outcomes:
measure: Target lesion failure (TLF)
timeFrame: 12 month after PCI
measure: Cardiac death
timeFrame: 12 month after PCI
measure: Myocardial infarction
timeFrame: 12 month after PCI
measure: Stent thrombosis
timeFrame: 12 month after PCI
Locations:
city: Novosibirsk
country: Russian Federation
facility: Academician E.N. Meshalkin national medical research center
Study officials:
References: