Bifurcation ABSORB OCT Trial (BISORB OCT)

• ClinicalTrials.gov Identifier: NCT02928198
• Recruitment Status: Unknown
• First Posted: October 10, 2016
• Last Update Posted: January 17, 2018
• Sponsor: J.J. Wykrzykowska
• Collaborator: Abbott Medical Devices
• Information provided by (Responsible Party): J.J. Wykrzykowska, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

Condition or disease	Intervention/treatment	Phase
Myocardial Ischemia; Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Coronary Bifurcation Lesions; Arterial Occlusive Lesions; Infarction; Myocardial Infarction; Arteriosclerosis	Device: ABSORB BVS	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Bifurcation ABSORB OCT Trial
• Study Start Date: June 2016
• Estimated Primary Completion Date: March 2020
• Estimated Study Completion Date: March 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort A [ Time Frame: 12 months ]
   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 :

1. Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - All cohorts [ Time Frame: Baseline ]
   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.
2. Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort B [ Time Frame: 24 months ]
   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.
3. Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort C [ Time Frame: 36 months ]
   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.
4. Incomplete strut apposition in the bifurcation region - All cohorts [ Time Frame: Baseline ]
   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.
5. Incomplete strut apposition in the bifurcation region - Cohort A [ Time Frame: 12 months ]
   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.
6. Incomplete strut apposition in the bifurcation region - Cohort B [ Time Frame: 24 months ]
   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.
7. Incomplete strut apposition in the bifurcation region - Cohort C [ Time Frame: 36 months ]
   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.
8. Number of embedded and protruded ABSORB BVS struts per region - All cohorts [ Time Frame: Baseline ]
   Embedded struts are defined as present when more than one-half thickness of the strut was impacted into the vessel wall.
9. Number of embedded and protruded ABSORB BVS struts per region - Cohort A [ Time Frame: 12 months ]
   Embedded struts are defined as present when more than one-half thickness of the strut was impacted into the vessel wall.
10. Number of embedded and protruded ABSORB BVS struts per region - Cohort B [ Time Frame: 24 months ]
    Embedded struts are defined as present when more than one-half thickness of the strut was impacted into the vessel wall.
11. Number of embedded and protruded ABSORB BVS struts per region - Cohort C [ Time Frame: 36 months ]
    Embedded struts are defined as present when more than one-half thickness of the strut was impacted into the vessel wall.
12. Incomplete strut coverage in the bifurcation region - Cohort A [ Time Frame: 12 months ]
    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.
13. Incomplete strut coverage in the bifurcation region - Cohort B [ Time Frame: 24 months ]
    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.
14. Incomplete strut coverage in the bifurcation region - Cohort C [ Time Frame: 36 months ]
    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.
15. The number of non-apposed side branch (NASB) struts - All cohorts [ Time Frame: Baseline ]
    Non-apposed side branch struts are defined as struts overlying the ostium of a sidebranch, post-scaffold deployment and at follow up.
16. The number of non-apposed side branch (NASB) struts - Cohort A [ Time Frame: 12 months ]
    Non-apposed side branch struts are defined as struts overlying the ostium of a sidebranch, post-scaffold deployment and at follow up.
17. The number of non-apposed side branch (NASB) struts - Cohort B [ Time Frame: 24 months ]
    Non-apposed side branch struts are defined as struts overlying the ostium of a sidebranch, post-scaffold deployment and at follow up.
18. The number of non-apposed side branch (NASB) struts - Cohort C [ Time Frame: 36 months ]
    Non-apposed side branch struts are defined as struts overlying the ostium of a sidebranch, post-scaffold deployment and at follow up.
19. Tissue in-between non-apposed side branch (NASB) struts - Cohort A [ Time Frame: 12 months ]
    Tissue in-between NASB struts is defined as any tissue between two NASB ABSORB struts more than two times the polymer thickness.
20. Tissue in-between non-apposed side branch (NASB) struts - Cohort B [ Time Frame: 24 months ]
    Tissue in-between NASB struts is defined as any tissue between two NASB ABSORB struts more than two times the polymer thickness.
21. Tissue in-between non-apposed side branch (NASB) struts - Cohort C [ Time Frame: 36 months ]
    Tissue in-between NASB struts is defined as any tissue between two NASB ABSORB struts more than two times the polymer thickness.
22. Mean/Minimal Lumen diameter/area - All cohorts [ Time Frame: Baseline ]
    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
23. Mean/Minimal Lumen diameter/area - Cohort A [ Time Frame: 12 months ]
    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. Mean/Minimal Lumen diameter/area - Cohort B [ Time Frame: 24 months ]
    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
25. Mean/Minimal Lumen diameter/area - Cohort C [ Time Frame: 36 months ]
    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
26. Mean/Minimal Scaffold diameter/area - All cohorts [ Time Frame: Baseline ]
    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.
27. Mean/Minimal Scaffold diameter/area - Cohort A [ Time Frame: 12 months ]
    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.
28. Mean/Minimal Scaffold diameter/area - Cohort B [ Time Frame: 24 months ]
    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.
29. Mean/Minimal Scaffold diameter/area - Cohort C [ Time Frame: 36 months ]
    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.
30. Neointima thickness - Cohort A [ Time Frame: 12 months ]
    Neointima thickness of the ABSORB BVS is measured from the endoluminal border of the black box to the lumen contour.
31. Neointima thickness - Cohort B [ Time Frame: 24 months ]
    Neointima thickness of the ABSORB BVS is measured from the endoluminal border of the black box to the lumen contour.
32. Neointima thickness - Cohort C [ Time Frame: 36 months ]
    Neointima thickness of the ABSORB BVS is measured from the endoluminal border of the black box to the lumen contour.
33. Scaffold pattern irregularities - All cohorts [ Time Frame: Baseline ]
    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.
34. Scaffold pattern irregularities - Cohort A [ Time Frame: 12 months ]
    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.
35. Scaffold pattern irregularities - Cohort B [ Time Frame: 24 months ]
    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. Scaffold pattern irregularities - Cohort C [ Time Frame: 36 months ]
    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.

Other Outcome Measures:

1. Quantitative Coronary Angiography (QCA) derived parameters - All cohorts [ Time Frame: Baseline ]
   Proximal 5mm side branch % diameter stenosis (DS) postnitrate
2. Quantitative Coronary Angiography (QCA) derived parameters - Cohort A [ Time Frame: 12 months ]
   Proximal 5mm side branch % diameter stenosis (DS) postnitrate
3. Quantitative Coronary Angiography (QCA) derived parameters - Cohort B [ Time Frame: 24 months ]
   Proximal 5mm side branch % diameter stenosis (DS) postnitrate
4. Quantitative Coronary Angiography (QCA) derived parameters - Cohort C [ Time Frame: 36 months ]
   Proximal 5mm side branch % diameter stenosis (DS) postnitrate
5. Quantitative Coronary Angiography (QCA) derived parameters - Cohort A [ Time Frame: 12 months ]
   In-segment Late Loss (LL) postnitrate
6. Quantitative Coronary Angiography (QCA) derived parameters - Cohort B [ Time Frame: 24 months ]
   In-segment Late Loss (LL) postnitrate
7. Quantitative Coronary Angiography (QCA) derived parameters - Cohort C [ Time Frame: 36 months ]
   In-segment Late Loss (LL) postnitrate
8. Quantitative Coronary Angiography (QCA) derived parameters - Cohort A [ Time Frame: 12 months ]
   Proximal Late Loss (LL) postnitrate
9. Quantitative Coronary Angiography (QCA) derived parameters - Cohort B [ Time Frame: 24 months ]
   Proximal Late Loss (LL) postnitrate
10. Quantitative Coronary Angiography (QCA) derived parameters - Cohort C [ Time Frame: 36 months ]
    Proximal Late Loss (LL) postnitrate
11. Quantitative Coronary Angiography (QCA) derived parameters - Cohort A [ Time Frame: 12 months ]
    Distal Late Loss (LL) postnitrate
12. Quantitative Coronary Angiography (QCA) derived parameters - Cohort B [ Time Frame: 24 months ]
    Distal Late Loss (LL) postnitrate
13. Quantitative Coronary Angiography (QCA) derived parameters - Cohort C [ Time Frame: 36 months ]
    Distal Late Loss (LL) postnitrate
14. Quantitative Coronary Angiography (QCA) derived parameters - All cohorts [ Time Frame: Baseline ]
    In-scaffold/in-stent, in-segment, proximal and distal Minimal Lumen Diameter (MLD) postnitrate
15. Quantitative Coronary Angiography (QCA) derived parameters - Cohort A [ Time Frame: 12 months ]
    In-scaffold/in-stent, in-segment, proximal and distal Minimal Lumen Diameter (MLD) postnitrate
16. Quantitative Coronary Angiography (QCA) derived parameters - Cohort B [ Time Frame: 24 months ]
    In-scaffold/in-stent, in-segment, proximal and distal Minimal Lumen Diameter (MLD) postnitrate
17. Quantitative Coronary Angiography (QCA) derived parameters - Cohort C [ Time Frame: 36 months ]
    In-scaffold/in-stent, in-segment, proximal and distal Minimal Lumen Diameter (MLD) postnitrate
18. Quantitative Coronary Angiography (QCA) derived parameters - All cohorts [ Time Frame: Baseline ]
    In-scaffold/in-stent, in-segment, proximal and distal % diameter stenosis (DS) postnitrate
19. Quantitative Coronary Angiography (QCA) derived parameters - Cohort A [ Time Frame: 12 months ]
    In-scaffold/in-stent, in-segment, proximal and distal % diameter stenosis (DS) postnitrate
20. Quantitative Coronary Angiography (QCA) derived parameters - Cohort B [ Time Frame: 24 months ]
    In-scaffold/in-stent, in-segment, proximal and distal % diameter stenosis (DS) postnitrate
21. Quantitative Coronary Angiography (QCA) derived parameters - Cohort C [ Time Frame: 36 months ]
    In-scaffold/in-stent, in-segment, proximal and distal % diameter stenosis (DS) postnitrate
22. Quantitative Coronary Angiography (QCA) derived parameters - Cohort A [ Time Frame: 12 months ]
    In-scaffold/in-stent, in-segment, proximal and distal angiographic binary restenosis rate postnitrate
23. Quantitative Coronary Angiography (QCA) derived parameters - Cohort B [ Time Frame: 24 months ]
    In-scaffold/in-stent, in-segment, proximal and distal angiographic binary restenosis rate postnitrate
24. Quantitative Coronary Angiography (QCA) derived parameters - Cohort C [ Time Frame: 36 months ]
    In-scaffold/in-stent, in-segment, proximal and distal angiographic binary restenosis rate postnitrate

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Netherlands

Academic Medical Center

Amsterdam, Netherlands, 1105AZ

Sponsors and Collaborators

J.J. Wykrzykowska

Abbott Medical Devices

Investigators

• Principal Investigator: Joanna J Wykrzykowska, MD, PhD; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

More Information

• Responsible Party: J.J. Wykrzykowska, MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• ClinicalTrials.gov Identifier: NCT02928198
• Other Study ID Numbers: NL50172.018.14
• First Posted: October 10, 2016
• Last Update Posted: January 17, 2018
• Last Verified: January 2018

Keywords provided by J.J. Wykrzykowska, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Tomography, Optical Coherence; Percutaneous Coronary Intervention; Cardiac Catheterization; Coronary Biovascular Scaffold

Additional relevant MeSH terms:

Cardiovascular Diseases; Myocardial Infarction; Heart Diseases; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Infarction; Ischemia; Pathologic Processes; Necrosis; Vascular Diseases; Arterial Occlusive Diseases