Back to resultsBifurcation ABSORB OCT Trial (BISORB OCT)
Primary Purpose
Myocardial Ischemia, Ischemia, Coronary Disease
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
ABSORB BVS
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Ischemia focused on measuring Tomography, Optical Coherence, Percutaneous Coronary Intervention, Cardiac Catheterization, Coronary Biovascular Scaffold
Eligibility Criteria
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.
Sites / Locations
- Academic Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Fenestration
No Fenestration
Arm Description
Fenestration of the Absorb Biovascular Scaffold towards the side-branch
No fenestration of the Absorb Biovascular Scaffold towards the side-branch
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
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
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
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
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.
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.
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.
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.
Neointima thickness - Cohort A
Neointima thickness of the ABSORB BVS is measured from the endoluminal border of the black box to the lumen contour.
Neointima thickness - Cohort B
Neointima thickness of the ABSORB BVS is measured from the endoluminal border of the black box to the lumen contour.
Neointima thickness - Cohort C
Neointima thickness of the ABSORB BVS is measured from the endoluminal border of the black box to the lumen contour.
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.
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.
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.
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.
Full Information
NCT ID
NCT02928198
First Posted
September 9, 2016
Last Updated
January 15, 2018
Sponsor
J.J. Wykrzykowska
Collaborators
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT02928198
Brief Title
Bifurcation ABSORB OCT Trial
Acronym
BISORB OCT
Official Title
Bifurcation ABSORB OCT Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
J.J. Wykrzykowska
Collaborators
Abbott Medical Devices
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischemia, Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Coronary Bifurcation Lesions, Arterial Occlusive Lesions, Infarction, Myocardial Infarction, Arteriosclerosis
Keywords
Tomography, Optical Coherence, Percutaneous Coronary Intervention, Cardiac Catheterization, Coronary Biovascular Scaffold
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fenestration
Arm Type
Active Comparator
Arm Description
Fenestration of the Absorb Biovascular Scaffold towards the side-branch
Arm Title
No Fenestration
Arm Type
Active Comparator
Arm Description
No fenestration of the Absorb Biovascular Scaffold towards the side-branch
Intervention Type
Device
Intervention Name(s)
ABSORB BVS
Primary Outcome Measure Information:
Title
Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort A
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - All cohorts
Description
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.
Time Frame
Baseline
Title
Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort B
Description
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.
Time Frame
24 months
Title
Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort C
Description
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.
Time Frame
36 months
Title
Incomplete strut apposition in the bifurcation region - All cohorts
Description
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.
Time Frame
Baseline
Title
Incomplete strut apposition in the bifurcation region - Cohort A
Description
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.
Time Frame
12 months
Title
Incomplete strut apposition in the bifurcation region - Cohort B
Description
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.
Time Frame
24 months
Title
Incomplete strut apposition in the bifurcation region - Cohort C
Description
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.
Time Frame
36 months
Title
Number of embedded and protruded ABSORB BVS struts per region - All cohorts
Description
Embedded struts are defined as present when more than one-half thickness of the strut was impacted into the vessel wall.
Time Frame
Baseline
Title
Number of embedded and protruded ABSORB BVS struts per region - Cohort A
Description
Embedded struts are defined as present when more than one-half thickness of the strut was impacted into the vessel wall.
Time Frame
12 months
Title
Number of embedded and protruded ABSORB BVS struts per region - Cohort B
Description
Embedded struts are defined as present when more than one-half thickness of the strut was impacted into the vessel wall.
Time Frame
24 months
Title
Number of embedded and protruded ABSORB BVS struts per region - Cohort C
Description
Embedded struts are defined as present when more than one-half thickness of the strut was impacted into the vessel wall.
Time Frame
36 months
Title
Incomplete strut coverage in the bifurcation region - Cohort A
Description
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.
Time Frame
12 months
Title
Incomplete strut coverage in the bifurcation region - Cohort B
Description
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.
Time Frame
24 months
Title
Incomplete strut coverage in the bifurcation region - Cohort C
Description
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.
Time Frame
36 months
Title
The number of non-apposed side branch (NASB) struts - All cohorts
Description
Non-apposed side branch struts are defined as struts overlying the ostium of a sidebranch, post-scaffold deployment and at follow up.
Time Frame
Baseline
Title
The number of non-apposed side branch (NASB) struts - Cohort A
Description
Non-apposed side branch struts are defined as struts overlying the ostium of a sidebranch, post-scaffold deployment and at follow up.
Time Frame
12 months
Title
The number of non-apposed side branch (NASB) struts - Cohort B
Description
Non-apposed side branch struts are defined as struts overlying the ostium of a sidebranch, post-scaffold deployment and at follow up.
Time Frame
24 months
Title
The number of non-apposed side branch (NASB) struts - Cohort C
Description
Non-apposed side branch struts are defined as struts overlying the ostium of a sidebranch, post-scaffold deployment and at follow up.
Time Frame
36 months
Title
Tissue in-between non-apposed side branch (NASB) struts - Cohort A
Description
Tissue in-between NASB struts is defined as any tissue between two NASB ABSORB struts more than two times the polymer thickness.
Time Frame
12 months
Title
Tissue in-between non-apposed side branch (NASB) struts - Cohort B
Description
Tissue in-between NASB struts is defined as any tissue between two NASB ABSORB struts more than two times the polymer thickness.
Time Frame
24 months
Title
Tissue in-between non-apposed side branch (NASB) struts - Cohort C
Description
Tissue in-between NASB struts is defined as any tissue between two NASB ABSORB struts more than two times the polymer thickness.
Time Frame
36 months
Title
Mean/Minimal Lumen diameter/area - All cohorts
Description
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
Time Frame
Baseline
Title
Mean/Minimal Lumen diameter/area - Cohort A
Description
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
Time Frame
12 months
Title
Mean/Minimal Lumen diameter/area - Cohort B
Description
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
Time Frame
24 months
Title
Mean/Minimal Lumen diameter/area - Cohort C
Description
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
Time Frame
36 months
Title
Mean/Minimal Scaffold diameter/area - All cohorts
Description
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.
Time Frame
Baseline
Title
Mean/Minimal Scaffold diameter/area - Cohort A
Description
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.
Time Frame
12 months
Title
Mean/Minimal Scaffold diameter/area - Cohort B
Description
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.
Time Frame
24 months
Title
Mean/Minimal Scaffold diameter/area - Cohort C
Description
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.
Time Frame
36 months
Title
Neointima thickness - Cohort A
Description
Neointima thickness of the ABSORB BVS is measured from the endoluminal border of the black box to the lumen contour.
Time Frame
12 months
Title
Neointima thickness - Cohort B
Description
Neointima thickness of the ABSORB BVS is measured from the endoluminal border of the black box to the lumen contour.
Time Frame
24 months
Title
Neointima thickness - Cohort C
Description
Neointima thickness of the ABSORB BVS is measured from the endoluminal border of the black box to the lumen contour.
Time Frame
36 months
Title
Scaffold pattern irregularities - All cohorts
Description
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.
Time Frame
Baseline
Title
Scaffold pattern irregularities - Cohort A
Description
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.
Time Frame
12 months
Title
Scaffold pattern irregularities - Cohort B
Description
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.
Time Frame
24 months
Title
Scaffold pattern irregularities - Cohort C
Description
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.
Time Frame
36 months
Other Pre-specified Outcome Measures:
Title
Quantitative Coronary Angiography (QCA) derived parameters - All cohorts
Description
Proximal 5mm side branch % diameter stenosis (DS) postnitrate
Time Frame
Baseline
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort A
Description
Proximal 5mm side branch % diameter stenosis (DS) postnitrate
Time Frame
12 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Description
Proximal 5mm side branch % diameter stenosis (DS) postnitrate
Time Frame
24 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort C
Description
Proximal 5mm side branch % diameter stenosis (DS) postnitrate
Time Frame
36 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort A
Description
In-segment Late Loss (LL) postnitrate
Time Frame
12 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Description
In-segment Late Loss (LL) postnitrate
Time Frame
24 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort C
Description
In-segment Late Loss (LL) postnitrate
Time Frame
36 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort A
Description
Proximal Late Loss (LL) postnitrate
Time Frame
12 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Description
Proximal Late Loss (LL) postnitrate
Time Frame
24 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort C
Description
Proximal Late Loss (LL) postnitrate
Time Frame
36 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort A
Description
Distal Late Loss (LL) postnitrate
Time Frame
12 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Description
Distal Late Loss (LL) postnitrate
Time Frame
24 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort C
Description
Distal Late Loss (LL) postnitrate
Time Frame
36 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - All cohorts
Description
In-scaffold/in-stent, in-segment, proximal and distal Minimal Lumen Diameter (MLD) postnitrate
Time Frame
Baseline
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort A
Description
In-scaffold/in-stent, in-segment, proximal and distal Minimal Lumen Diameter (MLD) postnitrate
Time Frame
12 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Description
In-scaffold/in-stent, in-segment, proximal and distal Minimal Lumen Diameter (MLD) postnitrate
Time Frame
24 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort C
Description
In-scaffold/in-stent, in-segment, proximal and distal Minimal Lumen Diameter (MLD) postnitrate
Time Frame
36 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - All cohorts
Description
In-scaffold/in-stent, in-segment, proximal and distal % diameter stenosis (DS) postnitrate
Time Frame
Baseline
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort A
Description
In-scaffold/in-stent, in-segment, proximal and distal % diameter stenosis (DS) postnitrate
Time Frame
12 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Description
In-scaffold/in-stent, in-segment, proximal and distal % diameter stenosis (DS) postnitrate
Time Frame
24 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort C
Description
In-scaffold/in-stent, in-segment, proximal and distal % diameter stenosis (DS) postnitrate
Time Frame
36 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort A
Description
In-scaffold/in-stent, in-segment, proximal and distal angiographic binary restenosis rate postnitrate
Time Frame
12 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Description
In-scaffold/in-stent, in-segment, proximal and distal angiographic binary restenosis rate postnitrate
Time Frame
24 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort C
Description
In-scaffold/in-stent, in-segment, proximal and distal angiographic binary restenosis rate postnitrate
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna J Wykrzykowska, MD, PhD
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Academic Medical Center
City
Amsterdam
ZIP/Postal Code
1105AZ
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Bifurcation ABSORB OCT Trial
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