BIOFREEDOM Stent Versus ORSIRO Stent: SORT OUT IX

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

3150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2023-10-31

Brief Summary

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The aim of the Danish Organization for Randomized Trials with Clinical Outcome (SORT OUT) is to compare the safety and efficacy of the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in a population-based setting, using registry detection of clinically driven events

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Detailed Description

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SORT OUT IX is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the polymer-free Biolimus-eluting BIOFREEDOM stent with a biodegradable-polymer Sirolimus-eluting ORSIRO stent in treating atherosclerotic coronary artery lesions.

Patients will be enrolled by the investigators and randomly allocated to treatment groups after diagnostic coronary angiography and before percutaneous coronary intervention. Block randomization by centre (permuted blocks of random sizes (2/4/6)) will be used to assign patients in a 1:1 ratio to receive the polymer-free Biolimus-eluting BIOFREEDOM stent (Biosensors) or the biodegradable-polymer Sirolimus-eluting ORSIRO stent (Biotronik). A web based Trial Partner randomization system will be used.

Conditions

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Ischaemic Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Biofreedom

Biofreedom stent treatment at index procedure

Group Type EXPERIMENTAL

Biofreedom

Intervention Type DEVICE

PCI with Biofreedom stent

Orsiro

Orsiro stent treatment at index procedure

Group Type ACTIVE_COMPARATOR

Orsiro

Intervention Type DEVICE

PCI with Orsiro stent

Interventions

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Biofreedom

PCI with Biofreedom stent

Intervention Type DEVICE

Orsiro

PCI with Orsiro stent

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18 years or over with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion with more than 50% diameter stenosis, requiring treatment with a drug-eluting stent.

Exclusion Criteria

* Life expectancy of less than one year; an allergy to aspirin, clopidogrel, ticagrelor, prasugral, biolimus or sirolimus; participation in another randomized trial; or inability to provide written informed consent.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No