The OCT SORT-OUT VIII Study

NCT ID: NCT02253108

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease Angina Pectoris Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SYNERGY drug eluting stent

Everolimus eluting bioresorbable polymer stent

Group Type EXPERIMENTAL

Everolimus eluting bioresorbable polymer stent

Intervention Type DEVICE

Biomatrix NeoFlex drug eluting stent

Biolimus eluting bioresorbable polymer stent

Group Type EXPERIMENTAL

Biolimus eluting bioresorbable polymer stent

Intervention Type DEVICE

Interventions

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Everolimus eluting bioresorbable polymer stent

Intervention Type DEVICE

Biolimus eluting bioresorbable polymer stent

Intervention Type DEVICE

Other Intervention Names

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SYNERGY Biomatrix NeoFlex

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital Skejby

OTHER

Sponsor Role lead

Biosensors International

OTHER

Sponsor Role collaborator

Boston Scientific Corporation

INDUSTRY

Sponsor Role collaborator

Responsible Party

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Evald Hoej Christiansen

MD, phd

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evald H Christiansen, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Aarhus University Hospital, Skejby

Aarhus, , Denmark

Site Status

Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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1-10-72-125-14

Identifier Type: -

Identifier Source: org_study_id

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