The Bioresorbable Implants for Scaffolding Obstructions in Randomized Bifurcations (BIFSORB) Study

Study Overview
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Brief Summary
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Coronary artery disease is often treated by implantation of permanent metallic stents.Coronary stents are required in the early healing phase after balloon dilatation but constitute a lifelong foreign body. New bioresorbable stents have been developed and are believed to improve long-term safety. The purpose of this study is to compare the safety and vessel healing after treatment of simple bifurcation lesions with the CE-marked bioresorbable stents Absorb and Desolve.

Detailed Description
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BIFSORB is a prospective, randomized multicenter trial comparing 6-month healing outcome after treatment of simple coronary bifurcation lesions by Absorb or Desolve BRS. for treatment of coronary bifurcation lesions. BRS 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 compare the 6 months safety and vessel healing after treatment of coronary bifurcation lesions by the Desolve or Absorb BRS. Hypothesis: Treatment of coronary bifurcation lesions using Absorb and Desolve bioresorbable stents is safe. Treatment of coronary bifurcation lesions by Desolve BRS is associated with a lower index of adverse vessel wall features (main vessel area stenosis, acquired malapposition, evaginations, late recoil, single end attached protruding struts, side branch ostial area stenosis) at 6 months compared to treatment with Absorb BRS. Methods: Prospective, open label, single blind, randomized, feasibility and safety pilot study with inclusion of 120 patients. Randomization 1:1 to Absorb or Desolve. Planned 6- and 24-month follow-up by OCT and follow-up for clinical endpoints until 10 years. 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 BRS. The patients are assessed by optical coherence tomography (OCT) before, during and after implantation of the Absorb or Desolve BRS at baseline procedure and again at 6- and 24-month follow-up, or before if they are readmitted with a possible target lesion failure. The operator is not blinded to pre-PCI OCT images that may be used for sizing and positioning of the scaffolds. Procedural OCT may be used to optimize scaffold implantation before performing final OCT. Results are reported as clinical safety at 6 months (myocardial infarction, revascularization, death) and stent healing index by OCT including malapposition, stent coverage, side branch ostial area late loss, fracture and evaginations.

Official Title
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Bioresorbable Vascular Stents for Treatment of Coronary Bifurcation Lesions Assessed by Optical Coherence Tomography - The BIFSORB Study

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Absorb
* Device: Desolve


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable angina pectoris Age > 18 years Stabilized non-ST elevation myocardial infarction Silent angina De novo coronary bifurcation lesions at LAD/diagonal, CX/obtuse marginal, RCA-PDA/posterolateral branch All Medina classes except Medina x.x.1 Diameter of side branch ≥ 2.5 mm 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 Allergy to contrast media, aspirin, clopidogrel, ticagrelor, ticlopidine, everolimus or novolimus Unable to cover main vessel lesion with one scaffold Severe tortuosity Severe calcification

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Absorb<br>Randomization to implantation of Absorb BVS in bifurcation lesion | Device: Absorb<br>* Randomization to implantation of Absorb BVS in bifurcation lesion<br>|
| Experimental: Desolve<br>Randomization to implantation of Desolve BRS in bifurcation lesion | Device: Desolve<br>* Randomization to implantation of Desolve BRS in bifurcation lesion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death. | Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death. | 6 months | 
| Index of adverse vessel wall features | 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optical coherence tomography endpoint: acute malapposition |  | Baseline | 
| Optical coherence tomography endpoint: acquired malapposition |  | 6 and 24 months | 
| Optical coherence tomography endpoint: persistent malapposition |  | 6 and 24 months | 
| Optical coherence tomography endpoint: Coverage of jailing struts |  | 6 and 24 months | 
| Optical coherence tomography endpoint: Extra stent lumen (including evaginations) |  | Baseline, 6 and 24 months | 
| Optical coherence tomography endpoint: Late stent recoil |  | 6 and 24 months | 
| Optical coherence tomography endpoint: stent fracture |  | Baseline, 6 and 24 months | 
| Optical coherence tomography endpoint: Single end attached protruding (floating) struts or neointimal tissue resembling struts |  | Baseline, 6 and 24 months | 
| Optical coherence tomography endpoint: Ostial strut loss |  | Baseline, 6 and 24 months | 
| Optical coherence tomography endpoint: Mean neointimal thickness |  | 6 and 24 months | 
| Optical coherence tomography endpoint: Stent strut coverage |  | 6 and 24 months | 
| Optical coherence tomography endpoint: Minimal luminal area in segmental analysis |  | Baseline, 6 and 24 months | 
| Optical coherence tomography endpoint: Minimal stent area in segmental analysis |  | Baseline, 6 and 24 months | 
| Optical coherence tomography endpoint: Minimum scaffold expansion area % |  | Baseline, 6 and 24 months | 
| Optical coherence tomography endpoint: Segmental area stenosis |  | Baseline, 6 and 24 months | 
| Optical coherence tomography endpoint: Healing above calcified plaque |  | 6 and 24 months | 
| Optical coherence tomography endpoint: Healing above lipid plaque |  | 6 and 24 months | 
| Optical coherence tomography endpoint: Acute thrombus on struts |  | Baseline | 
| Optical coherence tomography endpoint: Late thrombus on struts |  | 6 and 24 months | 
| 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 | 6 and 24 months | 
| Angiographic endpoint: Ostial side branch area stenosis |  | Baseline, 6 and 24 months | 
| Angiographic endpoint: Ostial side branch acute gain after main vessel stenting |  | Baseline | 
| Angiographic endpoint: Ostial side branch late loss |  | 6 and 24 months | 
| Angiographic endpoint: Ostial distal main vessel area stenosis |  | Baseline, 6 and 24 months | 
| Angiographic endpoint: Ostial distal main vessel acute gain after main vessel stenting |  | Baseline | 
| Angiographic endpoint: Ostial distal main vessel late loss |  | 6 and 24 months | 
| Angiographic endpoint: Proximal main vessel area stenosis |  | Baseline, 6 and 24 months | 
| Angiographic endpoint: Proximal main vessel acute gain after main vessel stenting |  | Baseline | 
| Angiographic endpoint: Proximal main vessel late loss |  | 6 and 24 months | 
| Angiographic endpoint: Minimal luminal area of all segments |  | Baseline, 6 and 24 months | 
| Procedural endpoints: Procedure time | From sheath insertion to closure device excluding treatment of other vessels | Baseline | 
| Procedural endpoints: Contrast use |  | Baseline | 
| Procedural endpoints: Fluoroscopy time |  | Baseline | 

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