The BIFSORB Pilot Study II

Coronary Artery Disease Clinical Trial

— BIFSORB P-II  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03027856
• Other study ID #: 1-10-72-194-16
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2016
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2021
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2024
• Est. primary completion date: August 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Magmaris
Implantation of a sirolimus eluting bioresorbable magnesium stent

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical endpoint: myocardial infarction		5 years
Other	Clinical endpoint: target lesion failure		5 years
Other	Clinical endpoint: target lesion revascularization		5 years
Other	Clinical endpoint: stent thrombosis		5 years
Other	Clinical endpoint: cardiac death		5 years
Other	Clinical endpoint: non-cardiac death		5 years
Primary	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
Primary	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	Optical coherence tomography endpoint: Acute malapposition		Baseline
Secondary	Optical coherence tomography endpoint: Acquired malapposition		1 month
Secondary	Optical coherence tomography endpoint: Persistent malapposition		1 month
Secondary	Optical coherence tomography endpoint: Coverage of jailing struts		1 month
Secondary	Optical coherence tomography endpoint: Extra stent lumen (including evaginations)		Baseline and 1 month
Secondary	Optical coherence tomography endpoint: Late stent recoil		1 month
Secondary	Optical coherence tomography endpoint: Stent fracture		Baseline and 1 month
Secondary	Optical coherence tomography endpoint: Single end attached protruding (floating) struts or neointimal tissue resembling struts		Baseline and 1 month
Secondary	Optical coherence tomography endpoint: Ostial strut loss		Baseline and 1 month
Secondary	Optical coherence tomography endpoint: Mean neointimal thickness		1 month
Secondary	Optical coherence tomography endpoint: Stent strut coverage		1 month
Secondary	Optical coherence tomography endpoint: Minimal luminal area in segmental analysis		Baseline and 1 month
Secondary	Optical coherence tomography endpoint: Minimal stent area in segmental analysis		Baseline and 1 month
Secondary	Optical coherence tomography endpoint: Minimum stent expansion area %		Baseline and 1 month
Secondary	Optical coherence tomography endpoint: Segmental area stenosis		Baseline and 1 month
Secondary	Optical coherence tomography endpoint: Healing above calcified plaque		1 month
Secondary	Optical coherence tomography endpoint: Healing above lipid plaque		1 month
Secondary	Optical coherence tomography endpoint: Acute thrombus on struts		Baseline
Secondary	Optical coherence tomography endpoint: Late thrombus on struts		1 month
Secondary	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
Secondary	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
Secondary	Angiographic endpoint: Ostial side branch area stenosis		Baseline and 1 month
Secondary	Angiographic endpoint: Ostial side branch acute gain after main vessel stenting		Baseline
Secondary	Angiographic endpoint: Ostial side branch late loss		1 month
Secondary	Angiographic endpoint: Ostial distal main vessel area stenosis		Baseline and 1 month
Secondary	Angiographic endpoint: Ostial distal main vessel acute gain after main vessel stenting		Baseline
Secondary	Angiographic endpoint: Ostial distal main vessel late loss		1 month
Secondary	Angiographic endpoint: Proximal main vessel area stenosis		Baseline and 1 month
Secondary	Angiographic endpoint: Proximal main vessel acute gain after main vessel stenting		Baseline
Secondary	Angiographic endpoint: Proximal main vessel late loss		1 month
Secondary	Angiographic endpoint: Minimal luminal area of all segments		Baseline and 1 month
Secondary	Procedural endpoint: Procedure time		Intraoperative
Secondary	Procedural endpoint: Contrast use in mL		Intraoperative
Secondary	Procedural endpoint: Fluoroscopy time		Intraoperative
Secondary	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
Secondary	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
Secondary	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