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

Coronary Artery Disease Clinical Trial

— BIFSORB  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02973529
• Other study ID #: 1-10-72-215-14
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: September 2028

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: September 2028
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Absorb
Randomization to implantation of Absorb BVS in bifurcation lesion
• Desolve
Randomization to implantation of Desolve BRS in bifurcation lesion

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus N
Denmark	Odense University Hospital	Odense
Denmark	Zealand University Hospital, Roskilde	Roskilde
Latvia	Latvian Heart Center	Riga

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby

Countries where clinical trial is conducted

Denmark,  Latvia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical endpoints: Myocardial infarction		10 years
Other	Clinical endpoints: Target lesion failure		10 years
Other	Clinical endpoints: Target lesion revascularization		10 years
Other	Clinical endpoints: Stent thrombosis		10 years
Other	Clinical endpoints: Cardiac death		10 years
Other	Clinical endpoints: Non-Cardiac death		10 years
Primary	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
Primary	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	Optical coherence tomography endpoint: acute malapposition		Baseline
Secondary	Optical coherence tomography endpoint: acquired malapposition		6 and 24 months
Secondary	Optical coherence tomography endpoint: persistent malapposition		6 and 24 months
Secondary	Optical coherence tomography endpoint: Coverage of jailing struts		6 and 24 months
Secondary	Optical coherence tomography endpoint: Extra stent lumen (including evaginations)		Baseline, 6 and 24 months
Secondary	Optical coherence tomography endpoint: Late stent recoil		6 and 24 months
Secondary	Optical coherence tomography endpoint: stent fracture		Baseline, 6 and 24 months
Secondary	Optical coherence tomography endpoint: Single end attached protruding (floating) struts or neointimal tissue resembling struts		Baseline, 6 and 24 months
Secondary	Optical coherence tomography endpoint: Ostial strut loss		Baseline, 6 and 24 months
Secondary	Optical coherence tomography endpoint: Mean neointimal thickness		6 and 24 months
Secondary	Optical coherence tomography endpoint: Stent strut coverage		6 and 24 months
Secondary	Optical coherence tomography endpoint: Minimal luminal area in segmental analysis		Baseline, 6 and 24 months
Secondary	Optical coherence tomography endpoint: Minimal stent area in segmental analysis		Baseline, 6 and 24 months
Secondary	Optical coherence tomography endpoint: Minimum scaffold expansion area %		Baseline, 6 and 24 months
Secondary	Optical coherence tomography endpoint: Segmental area stenosis		Baseline, 6 and 24 months
Secondary	Optical coherence tomography endpoint: Healing above calcified plaque		6 and 24 months
Secondary	Optical coherence tomography endpoint: Healing above lipid plaque		6 and 24 months
Secondary	Optical coherence tomography endpoint: Acute thrombus on struts		Baseline
Secondary	Optical coherence tomography endpoint: Late thrombus on struts		6 and 24 months
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	6 and 24 months
Secondary	Angiographic endpoint: Ostial side branch area stenosis		Baseline, 6 and 24 months
Secondary	Angiographic endpoint: Ostial side branch acute gain after main vessel stenting		Baseline
Secondary	Angiographic endpoint: Ostial side branch late loss		6 and 24 months
Secondary	Angiographic endpoint: Ostial distal main vessel area stenosis		Baseline, 6 and 24 months
Secondary	Angiographic endpoint: Ostial distal main vessel acute gain after main vessel stenting		Baseline
Secondary	Angiographic endpoint: Ostial distal main vessel late loss		6 and 24 months
Secondary	Angiographic endpoint: Proximal main vessel area stenosis		Baseline, 6 and 24 months
Secondary	Angiographic endpoint: Proximal main vessel acute gain after main vessel stenting		Baseline
Secondary	Angiographic endpoint: Proximal main vessel late loss		6 and 24 months
Secondary	Angiographic endpoint: Minimal luminal area of all segments		Baseline, 6 and 24 months
Secondary	Procedural endpoints: Procedure time	From sheath insertion to closure device excluding treatment of other vessels	Baseline
Secondary	Procedural endpoints: Contrast use		Baseline
Secondary	Procedural endpoints: Fluoroscopy time		Baseline