NCT01956448

Brief Summary

To perform a randomized comparison between the BioMatrix Flex™ and the Resolute Integrity® stents in the treatment of unselected patients with ischemic heart disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,800

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Mar 2011

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

3 active sites

Status
completed

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

Study Start

First participant enrolled

March 1, 2011

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2012

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
1.3 years until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
Last Updated

October 8, 2013

Status Verified

October 1, 2013

Enrollment Period

1.3 years

First QC Date

June 4, 2012

Last Update Submit

October 6, 2013

Conditions

Coronary Artery DiseaseAngina Pectoris

Keywords

Percutaneous coronary interventionDESAngina pectorisStent

Outcome Measures

Primary Outcomes (1)

  • Device-related combined endpoint

    Device-related combined endpoint hierarchically: cardiac death, non-index procedure related acute myocardial infarction not clearly related to another lesion than the target lesion (new revascularization by PCI or CABG) within 12 months.

    1,2,3 and 5 years

Secondary Outcomes (12)

  • Device success rate

    12 months

  • Procedure success rate

    12 months

  • Procedure time

    12 months

  • Fluoroscopy time

    12 months

  • Amount of contrast

    12 months

  • +7 more secondary outcomes

Study Arms (2)

Drug eluting stent (BioMatrix Flex)

EXPERIMENTAL

Device: Percutaneous coronary intervention with implantation of drug eluting stent (BioMatrix Flex)

Device: Drug eluting stent

Drug eluting stent (Resolute Integrity)

EXPERIMENTAL

Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity)

Device: Drug eluting stent

Interventions

Drug eluting stentDEVICE

Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity)

Also known as: BioMatrix Flex - biolimus eluting stent, Resolute - zotarolimus eluting stent
Drug eluting stent (BioMatrix Flex)Drug eluting stent (Resolute Integrity)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (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, prasugrel, sirolimus, or biolimus
  • participation in another randomized trial
  • inability to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aarhus University Hospital

Skejby, Aarhus N, 8200, Denmark

Location

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (2)

  • Raungaard B, Christiansen EH, Botker HE, Hansen HS, Ravkilde J, Thuesen L, Aaroe J, Villadsen AB, Terkelsen CJ, Krusell LR, Maeng M, Kristensen SD, Veien KT, Hansen KN, Junker A, Madsen M, Andersen SL, Jensen SE, Jensen LO; SORT OUT VI Investigators. Comparison of Durable-Polymer Zotarolimus-Eluting and Biodegradable-Polymer Biolimus-Eluting Coronary Stents in Patients With Coronary Artery Disease: 3-Year Clinical Outcomes in the Randomized SORT OUT VI Trial. JACC Cardiovasc Interv. 2017 Feb 13;10(3):255-264. doi: 10.1016/j.jcin.2016.11.007. Epub 2017 Jan 18.

    PMID: 28109874DERIVED

  • Raungaard B, Jensen LO, Tilsted HH, Christiansen EH, Maeng M, Terkelsen CJ, Krusell LR, Kaltoft A, Kristensen SD, Botker HE, Thuesen L, Aaroe J, Jensen SE, Villadsen AB, Thayssen P, Veien KT, Hansen KN, Junker A, Madsen M, Ravkilde J, Lassen JF; Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT). Zotarolimus-eluting durable-polymer-coated stent versus a biolimus-eluting biodegradable-polymer-coated stent in unselected patients undergoing percutaneous coronary intervention (SORT OUT VI): a randomised non-inferiority trial. Lancet. 2015 Apr 18;385(9977):1527-35. doi: 10.1016/S0140-6736(14)61794-3. Epub 2015 Jan 16.

    PMID: 25601789DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseAngina Pectoris

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Officials

  • Jan Ravkilde, MD

    Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, DMSc

Study Record Dates

First Submitted

June 4, 2012

First Posted

October 8, 2013

Study Start

March 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

October 8, 2013

Record last verified: 2013-10

Locations

DK(3)