The BIFSORB Pilot Study II (BIFSORB P-II)

A Sirolimus Eluting Bioresorbable Magnesium Stent for Treatment of Coronary Bifurcation Lesions - The BIFSORB Pilot Study II

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

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Magmaris

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N, Denmark, 8000
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Magmaris; Implantation of sirolimus eluting bioresorbable magnesium stent	Device: Magmaris; Implantation of a sirolimus eluting bioresorbable magnesium stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Optical coherence tomography endpoint: Late stent recoil		1 month
Optical coherence tomography endpoint: Stent fracture		Baseline and 1 month
Optical coherence tomography endpoint: Single end attached protruding (floating) struts or neointimal tissue resembling struts		Baseline and 1 month
Optical coherence tomography endpoint: Ostial strut loss		Baseline and 1 month
Optical coherence tomography endpoint: Mean neointimal thickness		1 month
Optical coherence tomography endpoint: Stent strut coverage		1 month
Optical coherence tomography endpoint: Minimal luminal area in segmental analysis		Baseline and 1 month
Optical coherence tomography endpoint: Minimal stent area in segmental analysis		Baseline and 1 month
Optical coherence tomography endpoint: Minimum stent expansion area %		Baseline and 1 month
Optical coherence tomography endpoint: Segmental area stenosis		Baseline and 1 month
Optical coherence tomography endpoint: Healing above calcified plaque		1 month
Optical coherence tomography endpoint: Healing above lipid plaque		1 month
Optical coherence tomography endpoint: Acute thrombus on struts		Baseline
Optical coherence tomography endpoint: Late thrombus on struts		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	Baseline
Optical coherence tomography endpoint: Late recoil	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	1 month
Angiographic endpoint: Ostial side branch area stenosis		Baseline and 1 month
Angiographic endpoint: Ostial side branch acute gain after main vessel stenting		Baseline
Angiographic endpoint: Ostial side branch late loss		1 month
Angiographic endpoint: Ostial distal main vessel area stenosis		Baseline and 1 month
Angiographic endpoint: Ostial distal main vessel acute gain after main vessel stenting		Baseline
Angiographic endpoint: Ostial distal main vessel late loss		1 month
Angiographic endpoint: Proximal main vessel area stenosis		Baseline and 1 month
Angiographic endpoint: Proximal main vessel acute gain after main vessel stenting		Baseline
Angiographic endpoint: Proximal main vessel late loss		1 month
Angiographic endpoint: Minimal luminal area of all segments		Baseline and 1 month
Procedural endpoint: Procedure time		Intraoperative
Procedural endpoint: Contrast use in mL		Intraoperative
Procedural endpoint: Fluoroscopy time		Intraoperative
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	6 months
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	24 months
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	60 months

Other Outcome Measures

Outcome Measure	Time Frame
Clinical endpoint: myocardial infarction	5 years
Clinical endpoint: target lesion failure	5 years
Clinical endpoint: target lesion revascularization	5 years
Clinical endpoint: stent thrombosis	5 years
Clinical endpoint: cardiac death	5 years
Clinical endpoint: non-cardiac death	5 years

Collaborators and Investigators

• Sponsor: Aarhus University Hospital Skejby
• Investigators: Principal Investigator: Evald H Christiansen, MD, PhD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): August 19, 2019
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: November 22, 2016
• First Submitted That Met QC Criteria: January 19, 2017
• First Posted (Estimate): January 23, 2017

Study Record Updates

• Last Update Posted (Actual): January 6, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Bifurcation lesion; Optical coherence tomography (OCT); Percutaneous intervention (PCI); Bioresorbable stents (BRS)
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 1-10-72-194-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided