Clinical trial NCT03027856: The BIFSORB Pilot Study II
Official title: A Sirolimus Eluting Bioresorbable Magnesium Stent for Treatment of Coronary Bifurcation Lesions - The BIFSORB Pilot Study II
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Percutaneous intervention (PCI)
Optical coherence tomography (OCT)
Bifurcation lesion
Bioresorbable stents (BRS)
Lead sponsor: Aarhus University Hospital Skejby
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
timeFrame: 1 month
measure: Index of adverse vessel wall features by OCT
timeFrame: 1 month
Secondary outcomes:
measure: Optical coherence tomography endpoint: Acute malapposition
timeFrame: Baseline
measure: Optical coherence tomography endpoint: Acquired malapposition
timeFrame: 1 month
measure: Optical coherence tomography endpoint: Persistent malapposition
timeFrame: 1 month
measure: Optical coherence tomography endpoint: Coverage of jailing struts
timeFrame: 1 month
measure: Optical coherence tomography endpoint: Extra stent lumen (including evaginations)
timeFrame: Baseline and 1 month
measure: Optical coherence tomography endpoint: Late stent recoil
timeFrame: 1 month
measure: Optical coherence tomography endpoint: Stent fracture
timeFrame: Baseline and 1 month
measure: Optical coherence tomography endpoint: Single end attached protruding (floating) struts or neointimal tissue resembling struts
timeFrame: Baseline and 1 month
measure: Optical coherence tomography endpoint: Ostial strut loss
timeFrame: Baseline and 1 month
measure: Optical coherence tomography endpoint: Mean neointimal thickness
timeFrame: 1 month
measure: Optical coherence tomography endpoint: Stent strut coverage
timeFrame: 1 month
measure: Optical coherence tomography endpoint: Minimal luminal area in segmental analysis
timeFrame: Baseline and 1 month
measure: Optical coherence tomography endpoint: Minimal stent area in segmental analysis
timeFrame: Baseline and 1 month
measure: Optical coherence tomography endpoint: Minimum stent expansion area %
timeFrame: Baseline and 1 month
measure: Optical coherence tomography endpoint: Segmental area stenosis
timeFrame: Baseline and 1 month
measure: Optical coherence tomography endpoint: Healing above calcified plaque
timeFrame: 1 month
measure: Optical coherence tomography endpoint: Healing above lipid plaque
timeFrame: 1 month
measure: Optical coherence tomography endpoint: Acute thrombus on struts
timeFrame: Baseline
measure: Optical coherence tomography endpoint: Late thrombus on struts
timeFrame: 1 month
measure: Optical coherence tomography endpoint: Acute expansion
timeFrame: Baseline
measure: Optical coherence tomography endpoint: Late recoil
timeFrame: 1 month
measure: Angiographic endpoint: Ostial side branch area stenosis
timeFrame: Baseline and 1 month
measure: Angiographic endpoint: Ostial side branch acute gain after main vessel stenting
timeFrame: Baseline
measure: Angiographic endpoint: Ostial side branch late loss
timeFrame: 1 month
measure: Angiographic endpoint: Ostial distal main vessel area stenosis
timeFrame: Baseline and 1 month
measure: Angiographic endpoint: Ostial distal main vessel acute gain after main vessel stenting
timeFrame: Baseline
measure: Angiographic endpoint: Ostial distal main vessel late loss
timeFrame: 1 month
measure: Angiographic endpoint: Proximal main vessel area stenosis
timeFrame: Baseline and 1 month
measure: Angiographic endpoint: Proximal main vessel acute gain after main vessel stenting
timeFrame: Baseline
measure: Angiographic endpoint: Proximal main vessel late loss
timeFrame: 1 month
measure: Angiographic endpoint: Minimal luminal area of all segments
timeFrame: Baseline and 1 month
measure: Procedural endpoint: Procedure time
timeFrame: Intraoperative
measure: Procedural endpoint: Contrast use in mL
timeFrame: Intraoperative
measure: Procedural endpoint: Fluoroscopy time
timeFrame: Intraoperative
measure: Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
timeFrame: 6 months
measure: Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
timeFrame: 24 months
measure: Combined endpoint of: major procedural myocardial infarction, non-procedural myocardial infarction, target lesion failure and cardiac death
timeFrame: 60 months
Other outcomes:
measure: Clinical endpoint: myocardial infarction
timeFrame: 5 years
measure: Clinical endpoint: target lesion failure
timeFrame: 5 years
measure: Clinical endpoint: target lesion revascularization
timeFrame: 5 years
measure: Clinical endpoint: stent thrombosis
timeFrame: 5 years
measure: Clinical endpoint: cardiac death
timeFrame: 5 years
measure: Clinical endpoint: non-cardiac death
timeFrame: 5 years
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Evald H Christiansen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: