NCT03027856Completed
The BIFSORB Pilot Study II
A Sirolimus Eluting Bioresorbable Magnesium Stent for Treatment of Coronary Bifurcation Lesions - The BIFSORB Pilot Study II
Source: ClinicalTrials.gov · Last updated 2 Jan 2026
Brief summary (registry, in English)
The purpose of this study is to investigate the feasibility and safety of the Magmaris BRS for treatment of coronary bifurcation lesions.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 22 Nov 2016
- Start date
- Sept 2016
- Primary completion date
- Aug 2019
- Lead sponsor
- Aarhus University Hospital Skejby
- Diseases
- Coronary artery disease
- NCT number
- NCT03027856
What you commit to
- Study type: Interventional
- Planned participants: 20
- From Sept 2016 to the primary completion date, Aug 2019
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe heart failure (NYHA≥III)
- Allergy to contrast media, aspirin, clopidogrel, ticagrelor, ticlopidine or sirolimus
Lab values
- S-creatinine \> 120 µmol/L or GFR \< 0.45 mL/min per 1.73 m2
Other
- ST-elevation infarction within 48 hours
- Expected survival \< 1 year
- Unable to cover main vessel lesion with one stent
- Severe tortuosity
- Severe calcification
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus N | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.