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BIOFREEDOM Stent Versus ORSIRO Stent: SORT OUT IX (SORT OUT IX)

Primary Purpose

Ischaemic Heart Disease

Status

Unknown status

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Biofreedom

Orsiro

About this trial

This is an interventional treatment trial for Ischaemic Heart Disease focused on measuring Coronary drug eluting stents, Outcomes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biofreedom

Orsiro

Arm Description

Biofreedom stent treatment at index procedure

Orsiro stent treatment at index procedure

Outcomes

Primary Outcome Measures

Target Lesion Failure

Primary endpoint assessed after 12 months

Secondary Outcome Measures

Target lesion failure

Target lesion failure will be assessed yearly up to 5 years after index procedure

Stent thrombosis

Stent thrombosis will be assessed yearly up to 5 years after index procedure

Myocardial infarction

Myocardial infarction will be assessed yearly up to 5 years after index procedure

Cardiac death

Cardiac death will be assessed yearly up to 5 years after index procedure

All cause mortality

All cause mortality will be assessed yearly up to 5 years after index procedure

Target lesion revascularization

Target lesion revascularization will be assessed yearly up to 5 years after index procedure

Target vessel revascularization

Target vessel revascularization will be assessed yearly up to 5 years after

Full Information

NCT ID

NCT02623140

First Posted

November 30, 2015

Last Updated

September 17, 2020

Sponsor

Odense University Hospital

Collaborators

Aarhus University Hospital Skejby, Aalborg University Hospital, Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT02623140

Brief Title

BIOFREEDOM Stent Versus ORSIRO Stent: SORT OUT IX

Acronym

SORT OUT IX

Official Title

Randomized Comparison of a Polymer-Free Biolimus-eluting BIOFREEDOM Stent With a Biodegradable-Polymer Sirolimus-eluting ORSIRO Stent in Patients Treated With Percutaneous Coronary Intervention

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

December 2015 (undefined)

Primary Completion Date

October 2018 (Actual)

Study Completion Date

October 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Odense University Hospital

Collaborators

Aarhus University Hospital Skejby, Aalborg University Hospital, Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischaemic Heart Disease

Keywords

Coronary drug eluting stents, Outcomes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

3150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Biofreedom

Arm Type

Experimental

Arm Description

Biofreedom stent treatment at index procedure

Arm Title

Orsiro

Arm Type

Active Comparator

Arm Description

Orsiro stent treatment at index procedure

Intervention Type

Device

Intervention Name(s)

Biofreedom

Intervention Description

PCI with Biofreedom stent

Intervention Type

Device

Intervention Name(s)

Orsiro

Intervention Description

PCI with Orsiro stent

Primary Outcome Measure Information:

Title

Target Lesion Failure

Description

Primary endpoint assessed after 12 months

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Target lesion failure

Description

Target lesion failure will be assessed yearly up to 5 years after index procedure

Time Frame

2 year, 3 year, 4 year, 5 year

Title

Stent thrombosis

Description

Stent thrombosis will be assessed yearly up to 5 years after index procedure

Time Frame