The OCT SORT-OUT VIII Study (OCT SORT-OUT)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Myocardial Infarction; Coronary Artery Disease; Angina Pectoris
• Intervention / Treatment: Device: Everolimus eluting bioresorbable polymer stent; Device: Biolimus eluting bioresorbable polymer stent

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 Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital, Skejby
  • Odense, Denmark, 5000
    • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SYNERGY drug eluting stent; Everolimus eluting bioresorbable polymer stent	Device: Everolimus eluting bioresorbable polymer stent; Other Names: SYNERGY
Experimental: Biomatrix NeoFlex drug eluting stent; Biolimus eluting bioresorbable polymer stent	Device: Biolimus eluting bioresorbable polymer stent; Other Names: Biomatrix NeoFlex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Coronary Stent Healing Index	Combined endpoint of vessel wall healing parameters assessed by optical coherence tomography (OCT)	1 or 3 months
Uncovered stent struts	Uncovered stent struts 2%=1, 5%=2, 10%=3, 15%=4, 20%=5, 25%=6, 30%=7, 35%=8, 40%=9	1 or 3 months
Uncovered stent struts in front of SBs, on acquired or persistent malapposed struts	Uncovered stent struts in front of side branchs (SB), on acquired or persistent malapposed struts10%=1, 20%=2, 30%=3 etc to 100%=0	1 and 3 months
Persistent malapposition	Persistent malapposition: >2 adjacent struts of at least 1 mm length =1; >2 mm=2; >3 mm=3	1 and 3 months
Neointimal thickness in one frame or lumen mean diameter stenosis	Neointimal thickness in one frame or lumen mean diameter stenosis >200=1; >300=2; >400=3 or diameter stenosis >50%=4; >75%=5	1 and 3 months
Acquired malapposition	Acquired malapposition: >2 adjacent struts of at least 1 mm length =2; > 2 mm=4; > 3 mm=6	1 and 3 months
Cumulated extra stent lumen increase in matched cross sectional analysis	Cumulated extra stent lumen increase in matched cross sectional analysis (measurement mean area)	1 and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Malapposition	Detectable separation between the vessel wall and strut in a cross section.	Baseline, 1 and 3 months
Coverage	Detectable tissue covering the strut	Baseline, 1 and 3 months
Fracture	Discontinuity of a strut evaluated by 3D reconstruction	Baseline, 1 and 3 months
Neointimal thickness (NIT)	Thickness of intima from leading strut surface to lumen boarder	Baseline, 1 and 3 months
Lumen area	Area of lumen in cross section	Baseline, 1 and 3 months
Stent area	Area of stent in cross section	Baseline, 1 and 3 months
Area stenosis (AS) %	Minimal luminal area/reference area (interpolated)	Baseline, 1 and 3 months
Minimum expansion of the stent	Expressed as absolute area and percentage of the closest reference area	Baseline, 1 and 3 months
Late recoil	Loss in stent area from baseline to follow-up	Baseline, 1 and 3 months
Lumen late loss	Loss in minimal lumen area from baseline to follow-up	Baseline, 1 and 3 months
Extra stent lumen	Area outside stent boarder limited by lumen boarder	Baseline, 1 and 3 months
Evaginations	Counts and descriptive by size (volume and depth)	Baseline, 1 and 3 months
Thrombus on struts	In final OCT after implantation and at follow-up	Baseline, 1 and 3 months
Acute expansion and late recoil	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	Baseline, 1 and 3 months
Target Lesion Failure (TLF)	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)	Within 12 months
Cardiac death	Stent related, major adverse cardiac events (MACE), serious complication at procedure	Baseline, 12, 24, 36, 48 and 60 months
Non-index procedure related acute myocardial infarction (AMI)	Defined as AMI not clearly related to another lesion than the target lesion	Baseline and within 12, 24, 36, 48 and 60 months
Target Lesion Revascularisation (TLR)	New revascularisation of TLR by percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) (TLR if significant stenosis += 5 mm distal/proximal)	Baseline and within 12, 24, 36, 48 and 60 months
All-cause death		12, 24, 36, 48 and 60 months
Stent thrombosis	According to ARC criteria	Baseline, 1, 12, 24, 36, 48 and 60 months
Device success rate	Defined as the frequency of successful implantation with residual stenosis <20% of the study stent in all the stenoses scheduled to be treated	Baseline
Procedural success rate	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	Baseline

Collaborators and Investigators

• Sponsor: Aarhus University Hospital Skejby
• Collaborators: Boston Scientific Corporation; Biosensors International

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2014
• Primary Completion (Actual): April 1, 2015
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: September 9, 2014
• First Submitted That Met QC Criteria: September 26, 2014
• First Posted (Estimate): October 1, 2014

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Stent; Optical coherence tomography; Angina pectoris; Stent thrombosis; DES
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Chest Pain; Myocardial Infarction; Infarction; Coronary Artery Disease; Angina Pectoris; Physiological Effects of Drugs; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Everolimus
• Other Study ID Numbers: 1-10-72-125-14