StEnt Coverage and Neointimal Tissue Characterization After eXtra Long evErolimus - Eluting Stent imPlantation

Not Applicable

• Conditions: Ischemic Heart Disease; Coronary Atherosclerosis; Coronary Artery Disease
• Interventions: Device: SYNERGY 48 mm; Procedure: PCI; Procedure: 3 month OCT follow-up; Procedure: 6 month OCT follow-up

• Registration Number: NCT03401216
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

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.

Study Timeline

• Study Start: 2017-03-20
• Study First Submitted: 2017-12-25
• Status Verified: 2018-01
• Study First Submitted QC: 2018-01-15
• Last Update Submitted: 2018-01-15
• Study First Posted: 2018-01-17
• Last Update Posted: 2018-01-17
• Primary Completion: 2018-04-30
• Study Completion: 2019-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SYNERGY 48 PCI + 3 month OCT follow-up	3 month OCT follow-up	Synergy 48 mm stent implantation followed by 3 month OCT imaging
SYNERGY 48 PCI + 6 month OCT follow-up	PCI	Synergy 48 mm stent implantation followed by 6 month OCT imaging
SYNERGY 48 PCI + 3 month OCT follow-up	SYNERGY 48 mm	Synergy 48 mm stent implantation followed by 3 month OCT imaging
SYNERGY 48 PCI + 6 month OCT follow-up	SYNERGY 48 mm	Synergy 48 mm stent implantation followed by 6 month OCT imaging
SYNERGY 48 PCI + 3 month OCT follow-up	PCI	Synergy 48 mm stent implantation followed by 3 month OCT imaging
SYNERGY 48 PCI + 6 month OCT follow-up	6 month OCT follow-up	Synergy 48 mm stent implantation followed by 6 month OCT imaging

Primary Outcome Measures

Name	Time	Method
Neointimal healing score	within 6 month after PCI	The neointimal healing score is based on four stent-related characteristics and is calculated on a lesion level: * Presence of filling defect (% intraluminal defect, ILD) is assigned a weight of "4".; * Presence of both malapposed and uncovered struts (% malapposed/ uncovered, MU) is assigned a weight of "3"; * Presence of uncovered struts alone (% malapposed, M) is assigned a weight of "2"; * Presence of malapposed struts alone (% uncovered, U) is assigned a weight of "1"

Secondary Outcome Measures

Name	Time	Method
Percentage of strut coverage assessed by OCT	within 6 month after PCI	In metallic DES, the struts are classified as covered in the presence of a coverage thickness \>0 μm (tissue can be identified above the struts).
Percentage of mature neointimal tissue assessed by OCT	within 6 month after PCI	To assess mature neointima an OCT-based grey-scale-signal-intensity (GSI)-analysis will be performed.

Trial Locations

Locations (1)

Academician E.N. Meshalkin national medical research center; 🇷🇺 Novosibirsk, Russian Federation