StEnt Coverage and Neointimal Tissue Characterization After eXtra Long evErolimus - Eluting Stent imPlantation
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 20, 2017
CompletedFirst Submitted
Initial submission to the registry
December 25, 2017
CompletedFirst Posted
Study publicly available on registry
January 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2019
CompletedJanuary 17, 2018
January 1, 2018
1.1 years
December 25, 2017
January 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (4)
Percentage of strut coverage assessed by OCT
within 3 month after PCI
Percentage of strut coverage assessed by OCT
within 6 month after PCI
Percentage of mature neointimal tissue assessed by OCT
within 3 month after PCI
Percentage of mature neointimal tissue assessed by OCT
within 6 month after PCI
Other Outcomes (4)
Target lesion failure (TLF)
12 month after PCI
Cardiac death
12 month after PCI
Myocardial infarction
12 month after PCI
- +1 more other outcomes
Study Arms (2)
SYNERGY 48 PCI + 3 month OCT follow-up
EXPERIMENTALSynergy 48 mm stent implantation followed by 3 month OCT imaging
SYNERGY 48 PCI + 6 month OCT follow-up
EXPERIMENTALSynergy 48 mm stent implantation followed by 6 month OCT imaging
Interventions
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)
Standard PCI procedure
Optical coherence tomography imaging of target vessel within 3 month after PCI
Optical coherence tomography imaging of target vessel within 5 month after PCI
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Academician E.N. Meshalkin national medical research center
Novosibirsk, 630055, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 25, 2017
First Posted
January 17, 2018
Study Start
March 20, 2017
Primary Completion
April 30, 2018
Study Completion
April 30, 2019
Last Updated
January 17, 2018
Record last verified: 2018-01