NCT03027856

Brief Summary

The purpose of this study is to investigate the feasibility and safety of the Magmaris BRS for treatment of coronary bifurcation lesions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

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

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2019

Completed
5.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 2, 2026

Status Verified

December 1, 2025

Enrollment Period

3 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)

  • Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death

    Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death

    1 month

  • Index of adverse vessel wall features by OCT

    Index based on: 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

    1 month

Secondary Outcomes (37)

  • Optical coherence tomography endpoint: Acute malapposition

    Baseline

  • Optical coherence tomography endpoint: Acquired malapposition

    1 month

  • Optical coherence tomography endpoint: Persistent malapposition

    1 month

  • Optical coherence tomography endpoint: Coverage of jailing struts

    1 month

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

    Baseline and 1 month

  • +32 more secondary outcomes

Other Outcomes (6)

  • Clinical endpoint: myocardial infarction

    5 years

  • Clinical endpoint: target lesion failure

    5 years

  • Clinical endpoint: target lesion revascularization

    5 years

  • +3 more other outcomes

Study Arms (1)

Magmaris

EXPERIMENTAL

Implantation of sirolimus eluting bioresorbable magnesium stent

Device: Magmaris

Interventions

MagmarisDEVICE

Implantation of a sirolimus eluting bioresorbable magnesium stent

Magmaris

Eligibility Criteria

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

You may qualify if:

  • Stable angina pectoris
  • Stabilized non-ST elevation myocardial infarction
  • Silent angina pectoris
  • Age \> 18 years
  • De novo coronary bifurcation lesion at LAD/diagonal, CX/obtuse marginal or RCA-PDA/posterolateral branch
  • All Medina classes except Medina x.x.1.
  • Diameter of side branch ≥ 2.5 mm
  • Side branch diameter stenosis less than 50%
  • 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 or GFR \< 0.45 mL/min per 1.73 m2
  • Allergy to contrast media, aspirin, clopidogrel, ticagrelor, ticlopidine or sirolimus
  • Unable to cover main vessel lesion with one stent
  • Severe tortuosity
  • Severe calcification

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarhus University Hospital

Aarhus N, 8000, Denmark

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
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator (MD, PhD)

Study Record Dates

First Submitted

November 22, 2016

First Posted

January 23, 2017

Study Start

September 1, 2016

Primary Completion

August 19, 2019

Study Completion

December 31, 2024

Last Updated

January 2, 2026

Record last verified: 2025-12

Locations

DK(1)