Back to resultsStEnt Coverage and Neointimal Tissue Characterization After eXtra Long evErolimus - Eluting Stent imPlantation
Primary Purpose
Ischemic Heart Disease, Coronary Artery Disease, Coronary Atherosclerosis
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
SYNERGY 48 mm
PCI
3 month OCT follow-up
6 month OCT follow-up
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Optical coherence tomography, Healing score, Neointimal coverage, synergy 48, long lesion
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
Sites / Locations
- Academician E.N. Meshalkin national medical research centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SYNERGY 48 PCI + 3 month OCT follow-up
SYNERGY 48 PCI + 6 month OCT follow-up
Arm Description
Synergy 48 mm stent implantation followed by 3 month OCT imaging
Synergy 48 mm stent implantation followed by 6 month OCT imaging
Outcomes
Primary Outcome Measures
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"
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"
Secondary Outcome Measures
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).
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).
Percentage of mature neointimal tissue assessed by OCT
To assess mature neointima an OCT-based grey-scale-signal-intensity (GSI)-analysis will be performed.
Percentage of mature neointimal tissue assessed by OCT
To assess mature neointima an OCT-based grey-scale-signal-intensity (GSI)-analysis will be performed.
Full Information
NCT ID
NCT03401216
First Posted
December 25, 2017
Last Updated
January 15, 2018
Sponsor
Meshalkin Research Institute of Pathology of Circulation
Collaborators
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT03401216
Brief Title
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
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Anticipated)
Study Completion Date
April 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meshalkin Research Institute of Pathology of Circulation
Collaborators
Boston Scientific Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Coronary Artery Disease, Coronary Atherosclerosis
Keywords
Optical coherence tomography, Healing score, Neointimal coverage, synergy 48, long lesion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SYNERGY 48 PCI + 3 month OCT follow-up
Arm Type
Experimental
Arm Description
Synergy 48 mm stent implantation followed by 3 month OCT imaging
Arm Title
SYNERGY 48 PCI + 6 month OCT follow-up
Arm Type
Experimental
Arm Description
Synergy 48 mm stent implantation followed by 6 month OCT imaging
Intervention Type
Device
Intervention Name(s)
SYNERGY 48 mm
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
PCI
Intervention Description
Standard PCI procedure
Intervention Type
Procedure
Intervention Name(s)
3 month OCT follow-up
Intervention Description
Optical coherence tomography imaging of target vessel within 3 month after PCI
Intervention Type
Procedure
Intervention Name(s)
6 month OCT follow-up
Intervention Description
Optical coherence tomography imaging of target vessel within 5 month after PCI
Primary Outcome Measure Information:
Title
Neointimal healing score
Description
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"
Time Frame
within 3 month after PCI
Title
Neointimal healing score
Description
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"
Time Frame
within 6 month after PCI
Secondary Outcome Measure Information:
Title
Percentage of strut coverage assessed by OCT
Description
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).
Time Frame
within 3 month after PCI
Title
Percentage of strut coverage assessed by OCT
Description
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).
Time Frame
within 6 month after PCI
Title
Percentage of mature neointimal tissue assessed by OCT
Description
To assess mature neointima an OCT-based grey-scale-signal-intensity (GSI)-analysis will be performed.
Time Frame
within 3 month after PCI
Title
Percentage of mature neointimal tissue assessed by OCT
Description
To assess mature neointima an OCT-based grey-scale-signal-intensity (GSI)-analysis will be performed.
Time Frame
within 6 month after PCI
Other Pre-specified Outcome Measures:
Title
Target lesion failure (TLF)
Description
TLF is defined as a composite endpoint of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization.
Time Frame
12 month after PCI
Title
Cardiac death
Description
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.
Time Frame
12 month after PCI
Title
Myocardial infarction
Description
Type 1, 2, 3, 4a, 4b according to Third Universal Definition of Myocardial Infarction
Time Frame
12 month after PCI
Title
Stent thrombosis
Description
Definite and probable, according to ARC definition,
Time Frame
12 month after PCI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksei Prokhorikhin, MD
Phone
+79137178040
Email
turbogold@list.ru
Facility Information:
Facility Name
Academician E.N. Meshalkin national medical research center
City
Novosibirsk
ZIP/Postal Code
630055
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evgeny Kretov, MD, PhD
Phone
+79137906533
Email
sibvolna2005@yandex.ru
First Name & Middle Initial & Last Name & Degree
Evgeny Kretov, MD, PhD
First Name & Middle Initial & Last Name & Degree
Aleksei Prokhorikhin, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
StEnt Coverage and Neointimal Tissue Characterization After eXtra Long evErolimus - Eluting Stent imPlantation
We'll reach out to this number within 24 hrs