NCT02973529

Brief Summary

Coronary artery disease is often treated by implantation of permanent metallic stents.Coronary stents are required in the early healing phase after balloon dilatation but constitute a lifelong foreign body. New bioresorbable stents have been developed and are believed to improve long-term safety. The purpose of this study is to compare the safety and vessel healing after treatment of simple bifurcation lesions with the CE-marked bioresorbable stents Absorb and Desolve.

Trial Health

78
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
28mo left

Started Jan 2016

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
2 countries

4 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 Progress82%
Jan 2016Sep 2028

Study Start

First participant enrolled

January 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
9.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

10.8 years

First QC Date

November 22, 2016

Last Update Submit

December 29, 2025

Conditions

Coronary Artery Disease

Keywords

Percutaneous intervention (PCI)Optical coherence tomography (OCT)Bifurcation lesionBioresorbable stents (BRS)

Outcome Measures

Primary Outcomes (2)

  • Number of participants with Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death.

    Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death.

    6 months

  • Index of adverse vessel wall features

    Side branch ostial area late loss, strut fracture, uncovered non-side branch apposed stent struts, uncovered stent struts in front of side branch, uncovered stent struts on acquired or persistent malapposed struts, persistent malapposition, max neointimal thickness/area stenosis, cumulated extra stent lumen gain

    6 months

Secondary Outcomes (34)

  • Optical coherence tomography endpoint: acute malapposition

    Baseline

  • Optical coherence tomography endpoint: acquired malapposition

    6 and 24 months

  • Optical coherence tomography endpoint: persistent malapposition

    6 and 24 months

  • Optical coherence tomography endpoint: Coverage of jailing struts

    6 and 24 months

  • Optical coherence tomography endpoint: Extra stent lumen (including evaginations)

    Baseline, 6 and 24 months

  • +29 more secondary outcomes

Other Outcomes (6)

  • Clinical endpoints: Myocardial infarction

    10 years

  • Clinical endpoints: Target lesion failure

    10 years

  • Clinical endpoints: Target lesion revascularization

    10 years

  • +3 more other outcomes

Study Arms (2)

Absorb

EXPERIMENTAL

Randomization to implantation of Absorb BVS in bifurcation lesion

Device: Absorb

Desolve

EXPERIMENTAL

Randomization to implantation of Desolve BRS in bifurcation lesion

Device: Desolve

Interventions

AbsorbDEVICE

Randomization to implantation of Absorb BVS in bifurcation lesion

Absorb
DesolveDEVICE

Randomization to implantation of Desolve BRS in bifurcation lesion

Desolve

Eligibility Criteria

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

You may qualify if:

  • Stable angina pectoris
  • Age \> 18 years
  • Stabilized non-ST elevation myocardial infarction
  • Silent angina
  • De novo coronary bifurcation lesions at LAD/diagonal, CX/obtuse marginal, RCA-PDA/posterolateral branch
  • All Medina classes except Medina x.x.1
  • Diameter of side branch ≥ 2.5 mm
  • Signed informed consent

You may not qualify if:

  • ST-elevation infarction within 48 hours
  • Expected survival \< 1 year
  • Severe heart failure (NYHA≥III)
  • S-creatinine \> 120 µmol/L
  • Allergy to contrast media, aspirin, clopidogrel, ticagrelor, ticlopidine, everolimus or novolimus
  • Unable to cover main vessel lesion with one scaffold
  • Severe tortuosity
  • Severe calcification

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Zealand University Hospital, Roskilde

Roskilde, Denmark

Location

Latvian Heart Center

Riga, Latvia

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Evald H Christiansen, MD, PhD

    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
Principal investigator (MD, PhD)

Study Record Dates

First Submitted

November 22, 2016

First Posted

November 25, 2016

Study Start

January 1, 2016

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

September 1, 2028

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

DK(3)LA(1)