The BIFSORB Pilot Study II (BIFSORB P-II)

A

Aarhus University Hospital Skejby

Status

Active, not recruiting

Conditions

Coronary Artery Disease

Treatments

Device: Magmaris

Study type

Interventional

Funder types

Other

Identifiers

NCT03027856
1-10-72-194-16

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Magmaris
Experimental group
Description:
Implantation of sirolimus eluting bioresorbable magnesium stent
Treatment:
Device: Magmaris

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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