Randomized Comparison of Biolimus-Eluting and Everolimus-Eluting Stents With Optical Coherence Tomography Guided Stent Implantation in ST Elevation Myocardial Infarction.A 9-Month Angiographic and Optical Coherence Tomography Follow-up.
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Coronary Heart Disease
- Sponsor
- Masaryk University
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- to compare a safety and effectiveness of third generation DES (biolimus A9 and everolimus) in patients with STEMI treated by primary PCI with OCT guidance with assessment of a MACE's at 9 month follow-up
- Last Updated
- 17 years ago
Overview
Brief Summary
The primary objective of this study is:
- comparison of a safety and effectiveness of third generation DES (biolimus A9 and everolimus) in patients with STEMI treated by primary PCI with OCT guidance. A rate of 9 month MACE (deaths, myocardial infarction, ischemia driven TLR) will be assessed in both groups.
The secondary outcomes are a comparison of (using OCT):
- number of uncovered stent struts
- number of malapposed stents struts
- in-stent neointimal volume
- in-segment assessment of vessel wall response to DES
Detailed Description
The aim of this multicenter, prospective, randomized trial with a core lab analysis is to assess the safety and effectiveness (at 9-month follow-up) of third generation DES (biolimus A9 and everolimus) in patients with evolving STEMI with the OCT guidance (to optimize a stent implantation) A serial OCT analysis will be performed to assess the number of either uncovered or malaposed stents strut and a degree of in-stent neointimal hyperplasia. Furthermore, the in-segment vessel wall response to DES implantation will also be analysed. The goal is to enroll 400 patients (200 in each group) with OCT guidance in 100 patients in each group.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Acute STEMI within 12 hours from symptoms onset
- •Native coronary disease with a lesion suitable for stenting
- •Vessel size in between 2.5-3.75mm
- •Patient is willing to provide written informed consent
- •Male or female patients between 18-85 years of age
Exclusion Criteria
- •Significant left main disease
- •Killip class IV
- •Known allergy to aspirin and or clopidogrel/ticlopidine
- •Recent bleeding (\<1month)
- •Patient in anticoagulant therapy
- •No suitable coronary anatomy for OCT scan (ostial lesion, very distal or large vessel /\>3.75mm in diameter/)
- •Severe liver or renal disease (Cr\>2.0)
- •Life expectancy \< 1 year
Outcomes
Primary Outcomes
to compare a safety and effectiveness of third generation DES (biolimus A9 and everolimus) in patients with STEMI treated by primary PCI with OCT guidance with assessment of a MACE's at 9 month follow-up
Time Frame: 2 years
Secondary Outcomes
- number of uncovered stent struts(2 years)
- number of malaposed stents struts(2 years)
- in-stent neointimal volume(2 years)
- in-segment assessment of vessel wall response to DES(2 years)