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

StEnt Coverage and Neointimal Tissue Characterization After eXtra Long evErolimus - Eluting Stent imPlantation: Prospective sTudy Using optIcal cOhereNce Tomography

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Ischemic Heart Disease; Coronary Atherosclerosis
• Intervention / Treatment: Device: SYNERGY 48 mm; Procedure: PCI; Procedure: 3 month OCT follow-up; Procedure: 6 month OCT follow-up

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Novosibirsk, Russian Federation, 630055
    • Recruiting
    • Academician E.N. Meshalkin national medical research center
    • Contact: Evgeny Kretov, MD, PhD; Phone Number: +79137906533; Email: sibvolna2005@yandex.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SYNERGY 48 PCI + 3 month OCT follow-up; Synergy 48 mm stent implantation followed by 3 month OCT imaging	Device: SYNERGY 48 mm; Material: Platinum-Chromium alloy. Stent strut thickness: 0.0029-0.0032 inches. Polymer carrier composed of PLGA (poly(DL-lactide-co-glycolide)). Drug product: Everolimus, 1µg per 1 mm2. Stent diameters available: 2.25; 2.50; 2.75; 3.00; 3.50; 4.00 mm. Stent length: 48 mm. Nominal balloon pressure: 11 atm. (1117 kPa). Manufacturing company: Boston Scientific Corporation (USA); Procedure: PCI; Standard PCI procedure; Procedure: 3 month OCT follow-up; Optical coherence tomography imaging of target vessel within 3 month after PCI
EXPERIMENTAL: SYNERGY 48 PCI + 6 month OCT follow-up; Synergy 48 mm stent implantation followed by 6 month OCT imaging	Device: SYNERGY 48 mm; Material: Platinum-Chromium alloy. Stent strut thickness: 0.0029-0.0032 inches. Polymer carrier composed of PLGA (poly(DL-lactide-co-glycolide)). Drug product: Everolimus, 1µg per 1 mm2. Stent diameters available: 2.25; 2.50; 2.75; 3.00; 3.50; 4.00 mm. Stent length: 48 mm. Nominal balloon pressure: 11 atm. (1117 kPa). Manufacturing company: Boston Scientific Corporation (USA); Procedure: PCI; Standard PCI procedure; Procedure: 6 month OCT follow-up; Optical coherence tomography imaging of target vessel within 5 month after PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neointimal healing score	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"	within 3 month after PCI
Neointimal healing score	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"	within 6 month after PCI

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of strut coverage assessed by OCT	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).	within 3 month after PCI
Percentage of strut coverage assessed by OCT	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).	within 6 month after PCI
Percentage of mature neointimal tissue assessed by OCT	To assess mature neointima an OCT-based grey-scale-signal-intensity (GSI)-analysis will be performed.	within 3 month after PCI
Percentage of mature neointimal tissue assessed by OCT	To assess mature neointima an OCT-based grey-scale-signal-intensity (GSI)-analysis will be performed.	within 6 month after PCI

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target lesion failure (TLF)	TLF is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization.	12 month after PCI
Cardiac death	Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.	12 month after PCI
Myocardial infarction	Type 1, 2, 3, 4a, 4b according to Third Universal Definition of Myocardial Infarction	12 month after PCI
Stent thrombosis	Definite and probable, according to ARC definition,	12 month after PCI

Collaborators and Investigators

• Sponsor: Meshalkin Research Institute of Pathology of Circulation
• Collaborators: Boston Scientific Corporation

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2017
• Primary Completion (ANTICIPATED): April 30, 2018
• Study Completion (ANTICIPATED): April 30, 2019

Study Registration Dates

• First Submitted: December 25, 2017
• First Submitted That Met QC Criteria: January 15, 2018
• First Posted (ACTUAL): January 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 15, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Optical coherence tomography; Healing score; Neointimal coverage; synergy 48; long lesion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Atherosclerosis
• Other Study ID Numbers: Exeption

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No