NCT02253108

Brief Summary

The purpose of this study is to compare early vessel healing after implantation of SYNERGY drug eluting stent (DES) or BioMatrix NeoFlex DES at one and three months in two cohorts.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for not_applicable coronary-artery-disease

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

2 active sites

Status
active not recruiting

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

May 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2014

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
11.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

11 months

First QC Date

September 9, 2014

Last Update Submit

December 29, 2025

Conditions

Coronary Artery DiseaseAngina PectorisMyocardial Infarction

Keywords

DESAngina pectorisStentOptical coherence tomographyStent thrombosis

Outcome Measures

Primary Outcomes (7)

  • Coronary Stent Healing Index

    Combined endpoint of vessel wall healing parameters assessed by optical coherence tomography (OCT)

    1 or 3 months

  • Uncovered stent struts

    Uncovered stent struts 2%=1, 5%=2, 10%=3, 15%=4, 20%=5, 25%=6, 30%=7, 35%=8, 40%=9

    1 or 3 months

  • Uncovered stent struts in front of SBs, on acquired or persistent malapposed struts

    Uncovered stent struts in front of side branchs (SB), on acquired or persistent malapposed struts10%=1, 20%=2, 30%=3 etc to 100%=0

    1 and 3 months

  • Persistent malapposition

    Persistent malapposition: \>2 adjacent struts of at least 1 mm length =1; \>2 mm=2; \>3 mm=3

    1 and 3 months

  • Neointimal thickness in one frame or lumen mean diameter stenosis

    Neointimal thickness in one frame or lumen mean diameter stenosis \>200=1; \>300=2; \>400=3 or diameter stenosis \>50%=4; \>75%=5

    1 and 3 months

  • Acquired malapposition

    Acquired malapposition: \>2 adjacent struts of at least 1 mm length =2; \> 2 mm=4; \> 3 mm=6

    1 and 3 months

  • Cumulated extra stent lumen increase in matched cross sectional analysis

    Cumulated extra stent lumen increase in matched cross sectional analysis (measurement mean area)

    1 and 3 months

Secondary Outcomes (22)

  • Malapposition

    Baseline, 1 and 3 months

  • Coverage

    Baseline, 1 and 3 months

  • Fracture

    Baseline, 1 and 3 months

  • Neointimal thickness (NIT)

    Baseline, 1 and 3 months

  • Lumen area

    Baseline, 1 and 3 months

  • +17 more secondary outcomes

Study Arms (2)

SYNERGY drug eluting stent

EXPERIMENTAL

Everolimus eluting bioresorbable polymer stent

Device: Everolimus eluting bioresorbable polymer stent

Biomatrix NeoFlex drug eluting stent

EXPERIMENTAL

Biolimus eluting bioresorbable polymer stent

Device: Biolimus eluting bioresorbable polymer stent

Interventions

Everolimus eluting bioresorbable polymer stentDEVICE
Also known as: SYNERGY
SYNERGY drug eluting stent
Biolimus eluting bioresorbable polymer stentDEVICE
Also known as: Biomatrix NeoFlex
Biomatrix NeoFlex drug eluting stent

Eligibility Criteria

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

You may qualify if:

  • Patients \>18 years to be treated with one or more drug-eluting stents in a coronary artery at Aarhus University Hospital or Odense University Hospital

You may not qualify if:

  • Age \<18 years
  • Do not wish to participate
  • Unable to provide written informed consent
  • Domicile outside Denmark
  • Do not speak Danish
  • Expected survival \<1 year
  • Allergy to aspirin, clopidogrel, prasugrel or ticagrelor
  • Hypersensitivity to everolimus or biolimus
  • The operator wishes to use other DES
  • Reduced renal function; creatinine\> 120 mmol / L
  • Only bare metal stent (BMS) implantation
  • Only plain old balloon angioplasty (POBA)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus University Hospital, Skejby

Aarhus, 8200, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Coronary Artery DiseaseAngina PectorisMyocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

  • Evald H Christiansen, MD

    Aarhus 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, phd

Study Record Dates

First Submitted

September 9, 2014

First Posted

October 1, 2014

Study Start

May 1, 2014

Primary Completion

April 1, 2015

Study Completion

June 1, 2026

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

DK(2)