Bifurcation ABSORB OCT Trial (BISORB OCT)

The Bifurcation ABSORB OCT Trial is a prospective, randomized (1:1) evaluation of the efficacy and performance of single ABSORB everolimus eluting bioresorbable vascular scaffold provisional strategy in the treatment of (a) coronary bifurcation lesion(s) in consecutive subjects with and without fenestration towards the side branch.

Patients included in this study will be divided into three different cohorts:

• Cohort A (patient 1-20): Angiographic FU with OCT at 12 months.
• Cohort B (patient 21-40): Angiographic FU with OCT at 24 months.
• Cohort C (patient 41-60): Angiographic FU with OCT at 36 months.

All patients will also have telephone FU at 30 days, 12, 24 and 36 months.

Inclusion of patients in the BISORB OCT trial stopped in November 2016 after safety concerns of the ABSORB BVS were reported. BISORB OCT included 3 patients, which were all included in the Academic Medical Center

Study Overview

• Status: Unknown
• Conditions: Myocardial Infarction; Infarction; Ischemia; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Coronary Disease; Arteriosclerosis; Coronary Bifurcation Lesions; Arterial Occlusive Lesions
• Intervention / Treatment: Device: ABSORB BVS

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1105AZ
    • Academic Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject has a bifurcation lesion involving a side-branch larger than 2 mm and having main branch involvement (Medina 0,0,1 lesions are excluded).
• Subject must agree to undergo all clinical investigation plan-required follow-up visits and to undergo follow-up angiography and optical coherence tomography.
• Subject is able to verbally confirm understanding and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure,as approved by the appropriate Ethics Committee.

Exclusion Criteria:

• Subject is younger than 18 years of age
• Subject is presenting with a STEMI
• Subject has a true bifurcation lesion where a priori two scaffold/stent strategy is planned.
• Subject has known hypersensitivity or contraindication to contrast, aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel, prasugrel and ticagrelor, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
• Known renal insufficiency (eg. estimated Glomerular Filtration Rate (eGFR) <60mL/min/1.73m2 or serum creatinine level of >2.5mg/dL or subject on dialysis)
• Subject with a limited life expectancy less than one year.
• Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff) or subject unable to read or write.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fenestration; Fenestration of the Absorb Biovascular Scaffold towards the side-branch	Device: ABSORB BVS
Active Comparator: No Fenestration; No fenestration of the Absorb Biovascular Scaffold towards the side-branch	Device: ABSORB BVS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort A	3D reconstruction assessment is done visually and the number of strut free compartments are categorized as follows: Non-jailed side branch or jailed side branch. Non-jailed side branch is defined as either no strut over the sidebranch is present or 1 of the BVS struts is present over the side branch but does not compartmentalize the side branch. Jailed side branch is defined as the BVS struts separate the side branch ostium into n compartments. The distribution of the struts creates different patterns of compartments: V, T, H, double V, double T, and double H.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - All cohorts	3D reconstruction assessment is done visually and the number of strut free compartments are categorized as follows: Non-jailed side branch or jailed side branch. Non-jailed side branch is defined as either no strut over the sidebranch is present or 1 of the BVS struts is present over the side branch but does not compartmentalize the side branch. Jailed side branch is defined as the BVS struts separate the side branch ostium into n compartments. The distribution of the struts creates different patterns of compartments: V, T, H, double V, double T, and double H.	Baseline
Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort B	3D reconstruction assessment is done visually and the number of strut free compartments are categorized as follows: Non-jailed side branch or jailed side branch. Non-jailed side branch is defined as either no strut over the sidebranch is present or 1 of the BVS struts is present over the side branch but does not compartmentalize the side branch. Jailed side branch is defined as the BVS struts separate the side branch ostium into n compartments. The distribution of the struts creates different patterns of compartments: V, T, H, double V, double T, and double H.	24 months
Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort C	3D reconstruction assessment is done visually and the number of strut free compartments are categorized as follows: Non-jailed side branch or jailed side branch. Non-jailed side branch is defined as either no strut over the sidebranch is present or 1 of the BVS struts is present over the side branch but does not compartmentalize the side branch. Jailed side branch is defined as the BVS struts separate the side branch ostium into n compartments. The distribution of the struts creates different patterns of compartments: V, T, H, double V, double T, and double H.	36 months
Incomplete strut apposition in the bifurcation region - All cohorts	Present when, in case of an ABSORB BVS, the abluminal surface of the polymeric strut (black box) is separated from the vessel wall by flush, between 0.5mm proximal and 0.5mm distal of the side branch.	Baseline
Incomplete strut apposition in the bifurcation region - Cohort A	Present when, in case of an ABSORB BVS, the abluminal surface of the polymeric strut (black box) is separated from the vessel wall by flush, between 0.5mm proximal and 0.5mm distal of the side branch.	12 months
Incomplete strut apposition in the bifurcation region - Cohort B	Present when, in case of an ABSORB BVS, the abluminal surface of the polymeric strut (black box) is separated from the vessel wall by flush, between 0.5mm proximal and 0.5mm distal of the side branch.	24 months
Incomplete strut apposition in the bifurcation region - Cohort C	Present when, in case of an ABSORB BVS, the abluminal surface of the polymeric strut (black box) is separated from the vessel wall by flush, between 0.5mm proximal and 0.5mm distal of the side branch.	36 months
Number of embedded and protruded ABSORB BVS struts per region - All cohorts	Embedded struts are defined as present when more than one-half thickness of the strut was impacted into the vessel wall.	Baseline
Number of embedded and protruded ABSORB BVS struts per region - Cohort A	Embedded struts are defined as present when more than one-half thickness of the strut was impacted into the vessel wall.	12 months
Number of embedded and protruded ABSORB BVS struts per region - Cohort B	Embedded struts are defined as present when more than one-half thickness of the strut was impacted into the vessel wall.	24 months
Number of embedded and protruded ABSORB BVS struts per region - Cohort C	Embedded struts are defined as present when more than one-half thickness of the strut was impacted into the vessel wall.	36 months
Incomplete strut coverage in the bifurcation region - Cohort A	Absence of strut coverage at the side-branch ostium is defined when one of the strut corners preserved a right angle shape without signs of neointimal tissue, between 0.5mm proximal and 0.5mm distal of the side branch.	12 months
Incomplete strut coverage in the bifurcation region - Cohort B	Absence of strut coverage at the side-branch ostium is defined when one of the strut corners preserved a right angle shape without signs of neointimal tissue, between 0.5mm proximal and 0.5mm distal of the side branch.	24 months
Incomplete strut coverage in the bifurcation region - Cohort C	Absence of strut coverage at the side-branch ostium is defined when one of the strut corners preserved a right angle shape without signs of neointimal tissue, between 0.5mm proximal and 0.5mm distal of the side branch.	36 months
The number of non-apposed side branch (NASB) struts - All cohorts	Non-apposed side branch struts are defined as struts overlying the ostium of a sidebranch, post-scaffold deployment and at follow up.	Baseline
The number of non-apposed side branch (NASB) struts - Cohort A	Non-apposed side branch struts are defined as struts overlying the ostium of a sidebranch, post-scaffold deployment and at follow up.	12 months
The number of non-apposed side branch (NASB) struts - Cohort B	Non-apposed side branch struts are defined as struts overlying the ostium of a sidebranch, post-scaffold deployment and at follow up.	24 months
The number of non-apposed side branch (NASB) struts - Cohort C	Non-apposed side branch struts are defined as struts overlying the ostium of a sidebranch, post-scaffold deployment and at follow up.	36 months
Tissue in-between non-apposed side branch (NASB) struts - Cohort A	Tissue in-between NASB struts is defined as any tissue between two NASB ABSORB struts more than two times the polymer thickness.	12 months
Tissue in-between non-apposed side branch (NASB) struts - Cohort B	Tissue in-between NASB struts is defined as any tissue between two NASB ABSORB struts more than two times the polymer thickness.	24 months
Tissue in-between non-apposed side branch (NASB) struts - Cohort C	Tissue in-between NASB struts is defined as any tissue between two NASB ABSORB struts more than two times the polymer thickness.	36 months
Mean/Minimal Lumen diameter/area - All cohorts	Lumen diameter and lumen area are measured at the (neo-)intima layer of the vessel wall, both pre- and post-scaffold deployment and at follow up. At baseline this is usually outside the scaffold diameter/area and at follow up into the scaffold diameter/area	Baseline
Mean/Minimal Lumen diameter/area - Cohort A	Lumen diameter and lumen area are measured at the (neo-)intima layer of the vessel wall, both pre- and post-scaffold deployment and at follow up. At baseline this is usually outside the scaffold diameter/area and at follow up into the scaffold diameter/area	12 months
Mean/Minimal Lumen diameter/area - Cohort B	Lumen diameter and lumen area are measured at the (neo-)intima layer of the vessel wall, both pre- and post-scaffold deployment and at follow up. At baseline this is usually outside the scaffold diameter/area and at follow up into the scaffold diameter/area	24 months
Mean/Minimal Lumen diameter/area - Cohort C	Lumen diameter and lumen area are measured at the (neo-)intima layer of the vessel wall, both pre- and post-scaffold deployment and at follow up. At baseline this is usually outside the scaffold diameter/area and at follow up into the scaffold diameter/area	36 months
Mean/Minimal Scaffold diameter/area - All cohorts	Scaffold diameter and scaffold area are measured at the abluminal border of the polymeric struts (black boxes), both post-scaffold deployment and at follow up.	Baseline
Mean/Minimal Scaffold diameter/area - Cohort A	Scaffold diameter and scaffold area are measured at the abluminal border of the polymeric struts (black boxes), both post-scaffold deployment and at follow up.	12 months
Mean/Minimal Scaffold diameter/area - Cohort B	Scaffold diameter and scaffold area are measured at the abluminal border of the polymeric struts (black boxes), both post-scaffold deployment and at follow up.	24 months
Mean/Minimal Scaffold diameter/area - Cohort C	Scaffold diameter and scaffold area are measured at the abluminal border of the polymeric struts (black boxes), both post-scaffold deployment and at follow up.	36 months
Neointima thickness - Cohort A	Neointima thickness of the ABSORB BVS is measured from the endoluminal border of the black box to the lumen contour.	12 months
Neointima thickness - Cohort B	Neointima thickness of the ABSORB BVS is measured from the endoluminal border of the black box to the lumen contour.	24 months
Neointima thickness - Cohort C	Neointima thickness of the ABSORB BVS is measured from the endoluminal border of the black box to the lumen contour.	36 months
Scaffold pattern irregularities - All cohorts	Scaffold pattern irregularities are defined when struts are found in locations incongruent with the scaffold pattern, this is measured post-scaffold deployment and at follow up. They are classified into 2 categories: 1) 2 struts overhanging each other in the same angular sector of the lumen perimeter, with or without malapposition; and/or 2) isolated struts located more or less at the center of the vessel without obvious connection to the expected adjacent strut pattern.	Baseline
Scaffold pattern irregularities - Cohort A	Scaffold pattern irregularities are defined when struts are found in locations incongruent with the scaffold pattern, this is measured post-scaffold deployment and at follow up. They are classified into 2 categories: 1) 2 struts overhanging each other in the same angular sector of the lumen perimeter, with or without malapposition; and/or 2) isolated struts located more or less at the center of the vessel without obvious connection to the expected adjacent strut pattern.	12 months
Scaffold pattern irregularities - Cohort B	Scaffold pattern irregularities are defined when struts are found in locations incongruent with the scaffold pattern, this is measured post-scaffold deployment and at follow up. They are classified into 2 categories: 1) 2 struts overhanging each other in the same angular sector of the lumen perimeter, with or without malapposition; and/or 2) isolated struts located more or less at the center of the vessel without obvious connection to the expected adjacent strut pattern.	24 months
Scaffold pattern irregularities - Cohort C	Scaffold pattern irregularities are defined when struts are found in locations incongruent with the scaffold pattern, this is measured post-scaffold deployment and at follow up. They are classified into 2 categories: 1) 2 struts overhanging each other in the same angular sector of the lumen perimeter, with or without malapposition; and/or 2) isolated struts located more or less at the center of the vessel without obvious connection to the expected adjacent strut pattern.	36 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative Coronary Angiography (QCA) derived parameters - All cohorts	Proximal 5mm side branch % diameter stenosis (DS) postnitrate	Baseline
Quantitative Coronary Angiography (QCA) derived parameters - Cohort A	Proximal 5mm side branch % diameter stenosis (DS) postnitrate	12 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B	Proximal 5mm side branch % diameter stenosis (DS) postnitrate	24 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort C	Proximal 5mm side branch % diameter stenosis (DS) postnitrate	36 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort A	In-segment Late Loss (LL) postnitrate	12 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B	In-segment Late Loss (LL) postnitrate	24 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort C	In-segment Late Loss (LL) postnitrate	36 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort A	Proximal Late Loss (LL) postnitrate	12 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B	Proximal Late Loss (LL) postnitrate	24 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort C	Proximal Late Loss (LL) postnitrate	36 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort A	Distal Late Loss (LL) postnitrate	12 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B	Distal Late Loss (LL) postnitrate	24 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort C	Distal Late Loss (LL) postnitrate	36 months
Quantitative Coronary Angiography (QCA) derived parameters - All cohorts	In-scaffold/in-stent, in-segment, proximal and distal Minimal Lumen Diameter (MLD) postnitrate	Baseline
Quantitative Coronary Angiography (QCA) derived parameters - Cohort A	In-scaffold/in-stent, in-segment, proximal and distal Minimal Lumen Diameter (MLD) postnitrate	12 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B	In-scaffold/in-stent, in-segment, proximal and distal Minimal Lumen Diameter (MLD) postnitrate	24 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort C	In-scaffold/in-stent, in-segment, proximal and distal Minimal Lumen Diameter (MLD) postnitrate	36 months
Quantitative Coronary Angiography (QCA) derived parameters - All cohorts	In-scaffold/in-stent, in-segment, proximal and distal % diameter stenosis (DS) postnitrate	Baseline
Quantitative Coronary Angiography (QCA) derived parameters - Cohort A	In-scaffold/in-stent, in-segment, proximal and distal % diameter stenosis (DS) postnitrate	12 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B	In-scaffold/in-stent, in-segment, proximal and distal % diameter stenosis (DS) postnitrate	24 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort C	In-scaffold/in-stent, in-segment, proximal and distal % diameter stenosis (DS) postnitrate	36 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort A	In-scaffold/in-stent, in-segment, proximal and distal angiographic binary restenosis rate postnitrate	12 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B	In-scaffold/in-stent, in-segment, proximal and distal angiographic binary restenosis rate postnitrate	24 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort C	In-scaffold/in-stent, in-segment, proximal and distal angiographic binary restenosis rate postnitrate	36 months

Collaborators and Investigators

• Sponsor: J.J. Wykrzykowska
• Collaborators: Abbott Medical Devices
• Investigators: Principal Investigator: Joanna J Wykrzykowska, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): March 1, 2020

Study Registration Dates

• First Submitted: September 9, 2016
• First Submitted That Met QC Criteria: October 6, 2016
• First Posted (Estimate): October 10, 2016

Study Record Updates

• Last Update Posted (Actual): January 17, 2018
• Last Update Submitted That Met QC Criteria: January 15, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; Cardiac Catheterization; Tomography, Optical Coherence; Coronary Biovascular Scaffold
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Vascular Diseases; Arterial Occlusive Diseases; Myocardial Infarction; Infarction; Heart Diseases; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases; Ischemia; Arteriosclerosis
• Other Study ID Numbers: NL50172.018.14