NCT02623140

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,150

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 7, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

2.8 years

First QC Date

November 30, 2015

Last Update Submit

September 17, 2020

Conditions

Ischaemic Heart Disease

Keywords

Coronary drug eluting stentsOutcomes

Outcome Measures

Primary Outcomes (1)

  • Target Lesion Failure

    Primary endpoint assessed after 12 months

    12 months

Secondary Outcomes (7)

  • Target lesion failure

    2 year, 3 year, 4 year, 5 year

  • Stent thrombosis

    1 year, 2 years, 3 years, 4 years, 5 years

  • Myocardial infarction

    1 year, 2 years, 3 years, 4 years, 5 years

  • Cardiac death

    1 year, 2 years, 3 years, 4 years, 5 years

  • All cause mortality

    1 year, 2 years, 3 years, 4 years, 5 years

  • +2 more secondary outcomes

Study Arms (2)

Biofreedom

EXPERIMENTAL

Biofreedom stent treatment at index procedure

Device: Biofreedom

Orsiro

ACTIVE COMPARATOR

Orsiro stent treatment at index procedure

Device: Orsiro

Interventions

BiofreedomDEVICE

PCI with Biofreedom stent

Biofreedom
OrsiroDEVICE

PCI with Orsiro stent

Orsiro

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (2)

  • Jensen Lisette Okkels, Maeng M, Raungaard B, Kahlert J, Ellert J, Jakobsen L, Villadsen AB, Veien KT, Kristensen SD, Ahlehoff O, Carstensen S, Christensen MK, Terkelsen CJ, Engstroem T, Hansen KN, Botker HE, Aaroe J, Thim T, Thuesen L, Freeman P, Aziz A, Eftekhari A, Junker A, Jensen SE, Lassen JF, Hansen HS, Christiansen EH; Sort Out IX Study Group. Randomized Comparison of the Polymer-Free Biolimus-Coated BioFreedom Stent With the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Orsiro Stent in an All-Comers Population Treated With Percutaneous Coronary Intervention: The SORT OUT IX Trial. Circulation. 2020 Jun 23;141(25):2052-2063. doi: 10.1161/CIRCULATIONAHA.119.040241. Epub 2020 May 21.

    PMID: 32434381DERIVED

  • Jensen LO, Maeng M, Raungaard B, Engstrom T, Hansen HS, Jensen SE, Botker HE, Kahlert J, Lassen JF, Christiansen EH. Comparison of the polymer-free biolimus-coated BioFreedom stent with the thin-strut biodegradable polymer sirolimus-eluting Orsiro stent in an all-comers population treated with percutaneous coronary intervention: Rationale and design of the randomized SORT OUT IX trial. Am Heart J. 2019 Jul;213:1-7. doi: 10.1016/j.ahj.2019.02.017. Epub 2019 Mar 14.

    PMID: 31055192DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Lisette Okkels Jensen, MD DMSci PhD

    Odense University Hospital

    STUDY CHAIR

  • Evald H Christiansen, MD PhD

    Aarhus University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD DMSci PhD

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 7, 2015

Study Start

December 1, 2015

Primary Completion

October 1, 2018

Study Completion

October 1, 2023

Last Updated

September 18, 2020

Record last verified: 2020-09

Locations

DK(1)