Clinical trial NCT02973529: The Bioresorbable Implants for Scaffolding Obstructions in Randomized Bifurcations (BIFSORB) Study
Official title: Bioresorbable Vascular Stents for Treatment of Coronary Bifurcation Lesions Assessed by Optical Coherence Tomography - The BIFSORB Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
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: 2016-11-25
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with Clinical safety measured as: major procedural myocardial infarction, non-procedural target vessel myocardial infarction, target lesion failure, cardiac death.
timeFrame: 6 months
measure: Index of adverse vessel wall features
timeFrame: 6 months
Secondary outcomes:
measure: Optical coherence tomography endpoint: acute malapposition
timeFrame: Baseline
measure: Optical coherence tomography endpoint: acquired malapposition
timeFrame: 6 and 24 months
measure: Optical coherence tomography endpoint: persistent malapposition
timeFrame: 6 and 24 months
measure: Optical coherence tomography endpoint: Coverage of jailing struts
timeFrame: 6 and 24 months
measure: Optical coherence tomography endpoint: Extra stent lumen (including evaginations)
timeFrame: Baseline, 6 and 24 months
measure: Optical coherence tomography endpoint: Late stent recoil
timeFrame: 6 and 24 months
measure: Optical coherence tomography endpoint: stent fracture
timeFrame: Baseline, 6 and 24 months
measure: Optical coherence tomography endpoint: Single end attached protruding (floating) struts or neointimal tissue resembling struts
timeFrame: Baseline, 6 and 24 months
measure: Optical coherence tomography endpoint: Ostial strut loss
timeFrame: Baseline, 6 and 24 months
measure: Optical coherence tomography endpoint: Mean neointimal thickness
timeFrame: 6 and 24 months
measure: Optical coherence tomography endpoint: Stent strut coverage
timeFrame: 6 and 24 months
measure: Optical coherence tomography endpoint: Minimal luminal area in segmental analysis
timeFrame: Baseline, 6 and 24 months
measure: Optical coherence tomography endpoint: Minimal stent area in segmental analysis
timeFrame: Baseline, 6 and 24 months
measure: Optical coherence tomography endpoint: Minimum scaffold expansion area %
timeFrame: Baseline, 6 and 24 months
measure: Optical coherence tomography endpoint: Segmental area stenosis
timeFrame: Baseline, 6 and 24 months
measure: Optical coherence tomography endpoint: Healing above calcified plaque
timeFrame: 6 and 24 months
measure: Optical coherence tomography endpoint: Healing above lipid plaque
timeFrame: 6 and 24 months
measure: Optical coherence tomography endpoint: Acute thrombus on struts
timeFrame: Baseline
measure: Optical coherence tomography endpoint: Late thrombus on struts
timeFrame: 6 and 24 months
measure: Optical coherence tomography endpoint: Acute expansion
timeFrame: Baseline
measure: Optical coherence tomography endpoint:Late recoil
timeFrame: 6 and 24 months
measure: Angiographic endpoint: Ostial side branch area stenosis
timeFrame: Baseline, 6 and 24 months
measure: Angiographic endpoint: Ostial side branch acute gain after main vessel stenting
timeFrame: Baseline
measure: Angiographic endpoint: Ostial side branch late loss
timeFrame: 6 and 24 months
measure: Angiographic endpoint: Ostial distal main vessel area stenosis
timeFrame: Baseline, 6 and 24 months
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: 6 and 24 months
measure: Angiographic endpoint: Proximal main vessel area stenosis
timeFrame: Baseline, 6 and 24 months
measure: Angiographic endpoint: Proximal main vessel acute gain after main vessel stenting
timeFrame: Baseline
measure: Angiographic endpoint: Proximal main vessel late loss
timeFrame: 6 and 24 months
measure: Angiographic endpoint: Minimal luminal area of all segments
timeFrame: Baseline, 6 and 24 months
measure: Procedural endpoints: Procedure time
timeFrame: Baseline
measure: Procedural endpoints: Contrast use
timeFrame: Baseline
measure: Procedural endpoints: Fluoroscopy time
timeFrame: Baseline
Other outcomes:
measure: Clinical endpoints: Myocardial infarction
timeFrame: 10 years
measure: Clinical endpoints: Target lesion failure
timeFrame: 10 years
measure: Clinical endpoints: Target lesion revascularization
timeFrame: 10 years
measure: Clinical endpoints: Stent thrombosis
timeFrame: 10 years
measure: Clinical endpoints: Cardiac death
timeFrame: 10 years
measure: Clinical endpoints: Non-Cardiac death
timeFrame: 10 years
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
city: Roskilde
country: Denmark
facility: Zealand University Hospital, Roskilde
city: Riga
country: Latvia
facility: Latvian Heart Center
Study officials:
affiliation: Aarhus University Hospital
name: Evald H Christiansen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: