The BIFSORB Pilot Study II

NCT ID: NCT03027856

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2024-12-31

Brief Summary

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

Detailed Description

Bioresorbable stents are promising in treatment of coronary artery disease. The concept of bifurcation treatment using BRS is particular appealing as struts covering the side branch ostium may resorb over time.

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

Hypothesis: treatment of coronary bifurcation lesions using the Magmaris BRS is safe and feasible.

Methods:

The study is a proof-of-concept, prospective, single arm study with inclusion of 20 patients. Planned 1-and 12-month follow-up by optical coherence tomography (OCT) and follow-up for clinical endpoints until 5 years.

Written informed consent is required before the procedure is performed. Eligible patients with a bifurcation lesion are treated by the provisional technique with mandatory jailing of the side branch and provisional opening of side branch ostium by the mini-kiss technique in case of severe pinching or TIMI-flow less than III. Proximal post-dilatation is mandatory. No dilatation beyond the expansion limits of the stent.

At baseline, the target lesion is assessed by OCT before, during and after implantation of the Magmaris BRS. OCT assessment is performed again at 1- and 12-month follow-up, or before if the patient is readmitted with a possible target lesion failure.

The operator is not blinded to the OCT images as pre-PCI images should be used for sizing and positioning of the stent, and procedural OCT images are used to optimize stent implantation before performing final OCT.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Magmaris

Implantation of sirolimus eluting bioresorbable magnesium stent

Group Type: EXPERIMENTAL

Magmaris

Intervention Type: DEVICE

Implantation of a sirolimus eluting bioresorbable magnesium stent

Interventions

Magmaris

Implantation of a sirolimus eluting bioresorbable magnesium stent

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aarhus University Hospital Skejby

OTHER

Sponsor Role: lead

Responsible Party

Evald Hoej Christiansen

Principal investigator (MD, PhD)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evald H Christiansen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Aarhus University Hospital

Aarhus N, , Denmark

Countries

Denmark

Other Identifiers

1-10-72-194-16

Identifier Type: -

Identifier Source: org_study_id