Randomized Comparison of the Biolimus-eluting Biomatrix Neoflex™ og Everolimus-eluting SYNERGY™ Stents in All-comer Patients With Ischemic Heart Disease - The OCT SORT-OUT VIII
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Aarhus University Hospital Skejby
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- Persistent malapposition
- Status
- Active, Not Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
The purpose of this study is to compare early vessel healing after implantation of SYNERGY drug eluting stent (DES) or BioMatrix NeoFlex DES at one and three months in two cohorts.
Detailed Description
Prospective, open label, single blind, randomized study with inclusion of 160 patients in two equal sized cohorts (A and B). Angiographic follow-up with optical coherence tomography (OCT) is performed at 1 month (Cohort A) and 3 months (Cohort B). Randomization 1:1 to SYNERGY or BioMatrix Neoflex. The Cohorts are included consecutively, Cohort A first.
Investigators
Evald Hoej Christiansen
MD, phd
Aarhus University Hospital Skejby
Eligibility Criteria
Inclusion Criteria
- •Patients \>18 years to be treated with one or more drug-eluting stents in a coronary artery at Aarhus University Hospital or Odense University Hospital
Exclusion Criteria
- •Age \<18 years
- •Do not wish to participate
- •Unable to provide written informed consent
- •Domicile outside Denmark
- •Do not speak Danish
- •Inclusion in the SORT-OUT VIII study
- •Inclusion in other stent studies
- •Expected survival \<1 year
- •Allergy to aspirin, clopidogrel, prasugrel or ticagrelor
- •Hypersensitivity to everolimus or biolimus
Outcomes
Primary Outcomes
Persistent malapposition
Time Frame: 1 and 3 months
Persistent malapposition: \>2 adjacent struts of at least 1 mm length =1; \>2 mm=2; \>3 mm=3
Acquired malapposition
Time Frame: 1 and 3 months
Acquired malapposition: \>2 adjacent struts of at least 1 mm length =2; \> 2 mm=4; \> 3 mm=6
Uncovered stent struts in front of SBs, on acquired or persistent malapposed struts
Time Frame: 1 and 3 months
Uncovered stent struts in front of side branchs (SB), on acquired or persistent malapposed struts10%=1, 20%=2, 30%=3 etc to 100%=0
Neointimal thickness in one frame or lumen mean diameter stenosis
Time Frame: 1 and 3 months
Neointimal thickness in one frame or lumen mean diameter stenosis \>200=1; \>300=2; \>400=3 or diameter stenosis \>50%=4; \>75%=5
Cumulated extra stent lumen increase in matched cross sectional analysis
Time Frame: 1 and 3 months
Cumulated extra stent lumen increase in matched cross sectional analysis (measurement mean area)
Coronary Stent Healing Index
Time Frame: 1 or 3 months
Combined endpoint of vessel wall healing parameters assessed by optical coherence tomography (OCT)
Uncovered stent struts
Time Frame: 1 or 3 months
Uncovered stent struts 2%=1, 5%=2, 10%=3, 15%=4, 20%=5, 25%=6, 30%=7, 35%=8, 40%=9
Secondary Outcomes
- Area stenosis (AS) %(Baseline, 1 and 3 months)
- Fracture(Baseline, 1 and 3 months)
- Malapposition(Baseline, 1 and 3 months)
- Lumen area(Baseline, 1 and 3 months)
- All-cause death(12, 24, 36, 48 and 60 months)
- Device success rate(Baseline)
- Coverage(Baseline, 1 and 3 months)
- Neointimal thickness (NIT)(Baseline, 1 and 3 months)
- Stent area(Baseline, 1 and 3 months)
- Extra stent lumen(Baseline, 1 and 3 months)
- Evaginations(Baseline, 1 and 3 months)
- Stent thrombosis(Baseline, 1, 12, 24, 36, 48 and 60 months)
- Lumen late loss(Baseline, 1 and 3 months)
- Minimum expansion of the stent(Baseline, 1 and 3 months)
- Late recoil(Baseline, 1 and 3 months)
- Target Lesion Failure (TLF)(Within 12 months)
- Thrombus on struts(Baseline, 1 and 3 months)
- Target Lesion Revascularisation (TLR)(Baseline and within 12, 24, 36, 48 and 60 months)
- Acute expansion and late recoil(Baseline, 1 and 3 months)
- Cardiac death(Baseline, 12, 24, 36, 48 and 60 months)
- Non-index procedure related acute myocardial infarction (AMI)(Baseline and within 12, 24, 36, 48 and 60 months)
- Procedural success rate(Baseline)