The BIFSORB Pilot Study II

Aarhus University Hospital Skejby20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease

Interventions

MagmarisDEVICE

Implantation of a sirolimus eluting bioresorbable magnesium stent

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Aarhus University Hospital

Aarhus N, Denmark

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 1 month

Secondary Outcomes

Optical coherence tomography endpoint: Acute malapposition

Time frame: Baseline

Optical coherence tomography endpoint: Acquired malapposition

Time frame: 1 month

Optical coherence tomography endpoint: Persistent malapposition

Time frame: 1 month

Optical coherence tomography endpoint: Coverage of jailing struts

Time frame: 1 month

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

Time frame: Baseline and 1 month

Optical coherence tomography endpoint: Late stent recoil

Time frame: 1 month

Optical coherence tomography endpoint: Stent fracture

Data from ClinicalTrials.gov

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Time frame: Baseline and 1 month

Optical coherence tomography endpoint: Single end attached protruding (floating) struts or neointimal tissue resembling struts

Time frame: Baseline and 1 month

Optical coherence tomography endpoint: Ostial strut loss

Time frame: Baseline and 1 month

Optical coherence tomography endpoint: Mean neointimal thickness

Time frame: 1 month

Optical coherence tomography endpoint: Stent strut coverage

Time frame: 1 month

Optical coherence tomography endpoint: Minimal luminal area in segmental analysis

Time frame: Baseline and 1 month

Optical coherence tomography endpoint: Minimal stent area in segmental analysis

Time frame: Baseline and 1 month

Optical coherence tomography endpoint: Minimum stent expansion area %

Time frame: Baseline and 1 month

Optical coherence tomography endpoint: Segmental area stenosis

Time frame: Baseline and 1 month

Optical coherence tomography endpoint: Healing above calcified plaque

Time frame: 1 month

Optical coherence tomography endpoint: Healing above lipid plaque

Time frame: 1 month

Optical coherence tomography endpoint: Acute thrombus on struts

Time frame: Baseline

Optical coherence tomography endpoint: Late thrombus on struts

Time frame: 1 month

Optical coherence tomography endpoint: Acute expansion

Measured in segments with: 1) calcified plaque, 2) lipid plaque, 3) area after predilatation \< 30% of reference area, 4) stenosed segments (\>50% area stenosis) with no dissections after predilatation

Time frame: Baseline

Optical coherence tomography endpoint: Late recoil

Time frame: 1 month

Angiographic endpoint: Ostial side branch area stenosis

Time frame: Baseline and 1 month

Angiographic endpoint: Ostial side branch acute gain after main vessel stenting

Time frame: Baseline

Angiographic endpoint: Ostial side branch late loss

Time frame: 1 month

Angiographic endpoint: Ostial distal main vessel area stenosis

Time frame: Baseline and 1 month

Angiographic endpoint: Ostial distal main vessel acute gain after main vessel stenting

Time frame: Baseline

Angiographic endpoint: Ostial distal main vessel late loss

Time frame: 1 month

Angiographic endpoint: Proximal main vessel area stenosis

Time frame: Baseline and 1 month

Angiographic endpoint: Proximal main vessel acute gain after main vessel stenting

Time frame: Baseline

Angiographic endpoint: Proximal main vessel late loss

Time frame: 1 month

Angiographic endpoint: Minimal luminal area of all segments

Time frame: Baseline and 1 month

Procedural endpoint: Procedure time

Time frame: Intraoperative

Procedural endpoint: Contrast use in mL

Time frame: Intraoperative

Procedural endpoint: Fluoroscopy time

Time frame: Intraoperative

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

Time frame: 6 months

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

Time frame: 24 months

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

Time frame: 60 months