The BIFSORB Pilot Study II

Study Overview
=================
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.

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

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Magmaris


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Magmaris<br>Implantation of sirolimus eluting bioresorbable magnesium stent | Device: Magmaris<br>* Implantation of a sirolimus eluting bioresorbable magnesium stent<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Percutaneous intervention (PCI), Optical coherence tomography (OCT), Bifurcation lesion, Bioresorbable stents (BRS)