NCT02093845

Brief Summary

The purpose of this study is to perform a randomised comparison between the SYNERGY and the Biomatrix NeoFlex stents in treatment of unselected patients with ischemic heart disease.

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
2,800

participants targeted

Target at P75+ for not_applicable coronary-artery-disease

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

3 active sites

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

Study Start

First participant enrolled

February 10, 2014

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 24, 2014

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 21, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2015

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 25, 2017

Status Verified

April 1, 2017

Enrollment Period

1.5 years

First QC Date

February 24, 2014

Last Update Submit

April 24, 2017

Conditions

Coronary Artery DiseaseIschemic Heart Disease

Keywords

Percutaneous coronary interventionDESAngina pectorisStent

Outcome Measures

Primary Outcomes (1)

  • Device-related target lesion failure

    Hierarchically as cardiac death, non-index procedure related acute myocardial infarction not clearly related to another lesion than the target lesion, or target lesion revascularisation (new revascularisation of target lesion revascularisation (significant stenosis in the stent =/+ 5 mm distal/proximal) by percutaneous coronary intervention or coronary artery bypass operation

    12 months

Secondary Outcomes (6)

  • Device-related target lesion failure

    2, 3, 4 and 5 years

  • Patient-related combined endpoint

    1, 2, 3, 4 and 5 year

  • Individual above mentioned stent- or patient-related endpoints

    1, 2, 3, 4 and 5 years

  • MACE

    1, 2, 3, 4 and 5 years

  • Stent thrombosis

    Within 24 hours, between 1 and 30 days, between 30 days and 12 months and after 1, 2, 3, 4 and 5 years

  • +1 more secondary outcomes

Study Arms (2)

SYNERGY

ACTIVE COMPARATOR

Coronary implantatation of the SYNERGY everolimus-eluting stent

Device: SYNERGY stent

Biomatrix Neoflex

ACTIVE COMPARATOR

Coronary implantation of the biolimus-eluting Biomatrix NeoFlex stent

Device: Biomatrix NeoFlex coronary stent

Interventions

Biomatrix NeoFlex coronary stentDEVICE

Percutaneous coronary intervention involving use of stent

Also known as: Biolimus-eluting Biomatrix NeoFlex coronary stent
Biomatrix Neoflex
SYNERGY stentDEVICE

Percutaneous coronary intervention involving use of stent

Also known as: Everolimus-eluting SYNERGY coronary stent
SYNERGY

Eligibility Criteria

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

You may qualify if:

  • All patients aged ≥18 years who are eligible for treatment with one or several drug-eluting coronary stents at one of the three heart centers in Odense, Skejby and Aalborg can be included in the study.

You may not qualify if:

  • Age \< 18 years
  • The patient does not wish to participate
  • The patient is not able to consent to randomization (eg intubated patients)
  • The patient do not live in West Denmark
  • The patient do not speak Danish
  • The patient is already included in this study
  • The patient is already participating in other stent studies
  • Life expectancy \<1 year
  • Allergic to Aspirin, clopidogrel, prasugrel or ticagrelor
  • Allergic to everolimus or biolimus
  • Only implanted BMS
  • Only performed POBA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Aarhus University Hospital

Skejby, Aarhus N, 8200, Denmark

Location

Aarhus University Hospital Aalborg

Aalborg, 9000, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Related Publications (1)

  • Maeng M, Christiansen EH, Raungaard B, Kahlert J, Terkelsen CJ, Kristensen SD, Carstensen S, Aaroe J, Jensen SE, Villadsen AB, Lassen JF, Thim T, Eftekhari A, Veien KT, Hansen KN, Junker A, Botker HE, Jensen LO; SORT OUT VIII Investigators. Everolimus-Eluting Versus Biolimus-Eluting Stents With Biodegradable Polymers in Unselected Patients Undergoing Percutaneous Coronary Intervention: A Randomized Noninferiority Trial With 1-Year Follow-Up (SORT OUT VIII Trial). JACC Cardiovasc Interv. 2019 Apr 8;12(7):624-633. doi: 10.1016/j.jcin.2018.12.036.

    PMID: 30947936DERIVED

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial IschemiaAngina Pectoris

Condition Hierarchy (Ancestors)

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

Study Officials

  • Michael Maeng, MD

    Aarhus University Hospital, Skejby, Aarhus N

    PRINCIPAL INVESTIGATOR

  • Evald H Christiansen, MD

    Aarhus University Hospital

    STUDY CHAIR

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

Study Record Dates

First Submitted

February 24, 2014

First Posted

March 21, 2014

Study Start

February 10, 2014

Primary Completion

August 24, 2015

Study Completion

December 31, 2020

Last Updated

April 25, 2017

Record last verified: 2017-04

Locations

DK(3)