The OCT SORT-OUT VIII Study

Coronary Artery Disease Clinical Trial

— OCT SORT-OUT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02253108
• Other study ID #: 1-10-72-125-14
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2014
• Est. completion date: December 2025

Study information

• Verified date: October 2022
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: December 2025
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Angina Pectoris
• Coronary Artery Disease
• Infarction
• Myocardial Infarction

Intervention

Device:
• Everolimus eluting bioresorbable polymer stent

• Biolimus eluting bioresorbable polymer stent

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Skejby	Aarhus
Denmark	Odense University Hospital	Odense

Sponsors (3)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby	Biosensors International, Boston Scientific Corporation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary Stent Healing Index	Combined endpoint of vessel wall healing parameters assessed by optical coherence tomography (OCT)	1 or 3 months
Primary	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
Primary	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
Primary	Persistent malapposition	Persistent malapposition: >2 adjacent struts of at least 1 mm length =1; >2 mm=2; >3 mm=3	1 and 3 months
Primary	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
Primary	Acquired malapposition	Acquired malapposition: >2 adjacent struts of at least 1 mm length =2; > 2 mm=4; > 3 mm=6	1 and 3 months
Primary	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	Malapposition	Detectable separation between the vessel wall and strut in a cross section.	Baseline, 1 and 3 months
Secondary	Coverage	Detectable tissue covering the strut	Baseline, 1 and 3 months
Secondary	Fracture	Discontinuity of a strut evaluated by 3D reconstruction	Baseline, 1 and 3 months
Secondary	Neointimal thickness (NIT)	Thickness of intima from leading strut surface to lumen boarder	Baseline, 1 and 3 months
Secondary	Lumen area	Area of lumen in cross section	Baseline, 1 and 3 months
Secondary	Stent area	Area of stent in cross section	Baseline, 1 and 3 months
Secondary	Area stenosis (AS) %	Minimal luminal area/reference area (interpolated)	Baseline, 1 and 3 months
Secondary	Minimum expansion of the stent	Expressed as absolute area and percentage of the closest reference area	Baseline, 1 and 3 months
Secondary	Late recoil	Loss in stent area from baseline to follow-up	Baseline, 1 and 3 months
Secondary	Lumen late loss	Loss in minimal lumen area from baseline to follow-up	Baseline, 1 and 3 months
Secondary	Extra stent lumen	Area outside stent boarder limited by lumen boarder	Baseline, 1 and 3 months
Secondary	Evaginations	Counts and descriptive by size (volume and depth)	Baseline, 1 and 3 months
Secondary	Thrombus on struts	In final OCT after implantation and at follow-up	Baseline, 1 and 3 months
Secondary	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
Secondary	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
Secondary	Cardiac death	Stent related, major adverse cardiac events (MACE), serious complication at procedure	Baseline, 12, 24, 36, 48 and 60 months
Secondary	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
Secondary	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
Secondary	All-cause death		12, 24, 36, 48 and 60 months
Secondary	Stent thrombosis	According to ARC criteria	Baseline, 1, 12, 24, 36, 48 and 60 months
Secondary	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
Secondary	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