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

Meshalkin Research Institute of Pathology of Circulation

Status: Unknown

Conditions: Coronary Artery Disease; Ischemic Heart Disease; Coronary Atherosclerosis

Treatments: Device: SYNERGY 48 mm; Procedure: 3 month OCT follow-up; Procedure: PCI; Procedure: 6 month OCT follow-up

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT03401216

Exeption

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

SYNERGY 48 PCI + 3 month OCT follow-up

Experimental group

Description:

Synergy 48 mm stent implantation followed by 3 month OCT imaging

Treatment:

Device: SYNERGY 48 mm

Procedure: 3 month OCT follow-up

Procedure: PCI

SYNERGY 48 PCI + 6 month OCT follow-up

Experimental group

Description:

Synergy 48 mm stent implantation followed by 6 month OCT imaging

Treatment:

Procedure: 6 month OCT follow-up

Device: SYNERGY 48 mm

Procedure: PCI