The OCT SORT-OUT VIII Study

Not Applicable

Active, not recruiting

• Conditions: Angina Pectoris; Myocardial Infarction; Coronary Artery Disease
• Interventions: Device: Biolimus eluting bioresorbable polymer stent; Device: Everolimus eluting bioresorbable polymer stent

• Registration Number: NCT02253108
• Lead Sponsor: Aarhus University Hospital Skejby

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-26
• Study First Posted: 2014-10-01
• Primary Completion: 2015-04
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-17
• Last Update Posted: 2022-10-18
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 160

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
• The operator wishes to use other DES
• Reduced renal function; creatinine> 120 mmol / L
• Only bare metal stent (BMS) implantation
• Only plain old balloon angioplasty (POBA)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biomatrix NeoFlex drug eluting stent	Biolimus eluting bioresorbable polymer stent	Biolimus eluting bioresorbable polymer stent
SYNERGY drug eluting stent	Everolimus eluting bioresorbable polymer stent	Everolimus eluting bioresorbable polymer stent

Primary Outcome Measures

Name	Time	Method
Persistent malapposition	1 and 3 months	Persistent malapposition: \>2 adjacent struts of at least 1 mm length =1; \>2 mm=2; \>3 mm=3
Acquired malapposition	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	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	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	1 and 3 months	Cumulated extra stent lumen increase in matched cross sectional analysis (measurement mean area)
Coronary Stent Healing Index	1 or 3 months	Combined endpoint of vessel wall healing parameters assessed by optical coherence tomography (OCT)
Uncovered stent struts	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 Outcome Measures

Name	Time	Method
Area stenosis (AS) %	Baseline, 1 and 3 months	Minimal luminal area/reference area (interpolated)
Malapposition	Baseline, 1 and 3 months	Detectable separation between the vessel wall and strut in a cross section.
Lumen area	Baseline, 1 and 3 months	Area of lumen in cross section
All-cause death	12, 24, 36, 48 and 60 months
Device success rate	Baseline	Defined as the frequency of successful implantation with residual stenosis \<20% of the study stent in all the stenoses scheduled to be treated
Coverage	Baseline, 1 and 3 months	Detectable tissue covering the strut
Fracture	Baseline, 1 and 3 months	Discontinuity of a strut evaluated by 3D reconstruction
Neointimal thickness (NIT)	Baseline, 1 and 3 months	Thickness of intima from leading strut surface to lumen boarder
Stent area	Baseline, 1 and 3 months	Area of stent in cross section
Extra stent lumen	Baseline, 1 and 3 months	Area outside stent boarder limited by lumen boarder
Evaginations	Baseline, 1 and 3 months	Counts and descriptive by size (volume and depth)
Stent thrombosis	Baseline, 1, 12, 24, 36, 48 and 60 months	According to ARC criteria
Minimum expansion of the stent	Baseline, 1 and 3 months	Expressed as absolute area and percentage of the closest reference area
Late recoil	Baseline, 1 and 3 months	Loss in stent area from baseline to follow-up
Target Lesion Failure (TLF)	Within 12 months	Stent related combined endpoint of Target Lesion Failure (TLF) hierarchically as cardiac death, non-index procedure related AMI (defined as AMI not clearly related to another lesion than the target lesion), or Target Lesion Revascularisation (TLR) (by PCI or CABG - TLR if significant stenosis + 5mm distal/proximal)
Lumen late loss	Baseline, 1 and 3 months	Loss in minimal lumen area from baseline to follow-up
Thrombus on struts	Baseline, 1 and 3 months	In final OCT after implantation and at follow-up
Target Lesion Revascularisation (TLR)	Baseline and within 12, 24, 36, 48 and 60 months	New revascularisation of TLR by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) (TLR if significant stenosis += 5 mm distal/proximal)
Acute expansion and late recoil	Baseline, 1 and 3 months	In segments with; 1)calcified plaque, 2)lipid plaque, 3)area after predilatation \<30% of reference area, 4)stenosed segments (\>50% AS) with no dissections after predilatation
Cardiac death	Baseline, 12, 24, 36, 48 and 60 months	Stent related, major adverse cardiac events (MACE), serious complication at procedure
Non-index procedure related acute myocardial infarction (AMI)	Baseline and within 12, 24, 36, 48 and 60 months	Defined as AMI not clearly related to another lesion than the target lesion
Procedural success rate	Baseline	Defined as the frequency of successful implantation with residual stenosis \<20% of the study stent in all the stenoses scheduled to be treated and without serious complications

Trial Locations

Locations (2)

Aarhus University Hospital, Skejby; 🇩🇰 Aarhus, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark