StEnt Coverage and Neointimal Tissue Characterization After eXtra Long evErolimus - Eluting Stent imPlantation: Prospective sTudy Using optIcal cOhereNce Tomography
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Neointimal healing score
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
SYNERGY 48 PCI + 3 month OCT follow-up
Synergy 48 mm stent implantation followed by 3 month OCT imaging
Intervention: SYNERGY 48 mm (Device)
SYNERGY 48 PCI + 3 month OCT follow-up
Synergy 48 mm stent implantation followed by 3 month OCT imaging
Intervention: PCI (Procedure)
SYNERGY 48 PCI + 3 month OCT follow-up
Synergy 48 mm stent implantation followed by 3 month OCT imaging
Intervention: 3 month OCT follow-up (Procedure)
SYNERGY 48 PCI + 6 month OCT follow-up
Synergy 48 mm stent implantation followed by 6 month OCT imaging
Intervention: SYNERGY 48 mm (Device)
SYNERGY 48 PCI + 6 month OCT follow-up
Synergy 48 mm stent implantation followed by 6 month OCT imaging
Intervention: PCI (Procedure)
SYNERGY 48 PCI + 6 month OCT follow-up
Synergy 48 mm stent implantation followed by 6 month OCT imaging
Intervention: 6 month OCT follow-up (Procedure)
Outcomes
Primary Outcomes
Neointimal healing score
Time Frame: 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 Outcomes
- Percentage of strut coverage assessed by OCT(within 6 month after PCI)
- Percentage of mature neointimal tissue assessed by OCT(within 6 month after PCI)