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Status unknownNCT02928198BISORB OCTUpdated Jan 17, 2018

Bifurcation ABSORB OCT Trial

An interventional study of ABSORB BVS in Myocardial Ischemia, Ischemia and Coronary Disease, sponsored by J.J. Wykrzykowska. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-17.

Sponsored by J.J. Wykrzykowska · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
3
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • 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
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 3 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

This is the only study on the registry with J.J. Wykrzykowska as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
3 participants (actual)

Study arms

  • 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

Interventions

  • DeviceABSORB BVS
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

Secondary outcomes

  1. 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.

    Time frame: Baseline

  2. 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.

    Time frame: 24 months

  3. 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.

    Time frame: 36 months

  4. 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.

    Time frame: Baseline

  5. 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.

    Time frame: 12 months

  6. 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.

    Time frame: 24 months

  7. 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.

    Time frame: 36 months

  8. 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.

    Time frame: Baseline

  9. 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.

    Time frame: 12 months

  10. 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.

    Time frame: 24 months

  11. 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.

    Time frame: 36 months

  12. 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.

    Time frame: 12 months

  13. 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.

    Time frame: 24 months

  14. 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.

    Time frame: 36 months

  15. 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.

    Time frame: Baseline

  16. 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.

    Time frame: 12 months

  17. 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.

    Time frame: 24 months

  18. 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.

    Time frame: 36 months

  19. 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.

    Time frame: 12 months

  20. 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.

    Time frame: 24 months

  21. 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.

    Time frame: 36 months

  22. 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

    Time frame: Baseline

  23. 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

    Time frame: 12 months

  24. 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

    Time frame: 24 months

  25. 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

    Time frame: 36 months

  26. 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.

    Time frame: Baseline

  27. 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.

    Time frame: 12 months

  28. 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.

    Time frame: 24 months

  29. 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.

    Time frame: 36 months

  30. Neointima thickness - Cohort A

    Neointima thickness of the ABSORB BVS is measured from the endoluminal border of the black box to the lumen contour.

    Time frame: 12 months

  31. Neointima thickness - Cohort B

    Neointima thickness of the ABSORB BVS is measured from the endoluminal border of the black box to the lumen contour.

    Time frame: 24 months

  32. Neointima thickness - Cohort C

    Neointima thickness of the ABSORB BVS is measured from the endoluminal border of the black box to the lumen contour.

    Time frame: 36 months

  33. 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.

    Time frame: Baseline

  34. 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.

    Time frame: 12 months

  35. 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.

    Time frame: 24 months

  36. 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.

    Time frame: 36 months

Other outcomes

  1. Quantitative Coronary Angiography (QCA) derived parameters - All cohorts

    Proximal 5mm side branch % diameter stenosis (DS) postnitrate

    Time frame: Baseline

  2. Quantitative Coronary Angiography (QCA) derived parameters - Cohort A

    Proximal 5mm side branch % diameter stenosis (DS) postnitrate

    Time frame: 12 months

  3. Quantitative Coronary Angiography (QCA) derived parameters - Cohort B

    Proximal 5mm side branch % diameter stenosis (DS) postnitrate

    Time frame: 24 months

  4. Quantitative Coronary Angiography (QCA) derived parameters - Cohort C

    Proximal 5mm side branch % diameter stenosis (DS) postnitrate

    Time frame: 36 months

  5. Quantitative Coronary Angiography (QCA) derived parameters - Cohort A

    In-segment Late Loss (LL) postnitrate

    Time frame: 12 months

  6. Quantitative Coronary Angiography (QCA) derived parameters - Cohort B

    In-segment Late Loss (LL) postnitrate

    Time frame: 24 months

  7. Quantitative Coronary Angiography (QCA) derived parameters - Cohort C

    In-segment Late Loss (LL) postnitrate

    Time frame: 36 months

  8. Quantitative Coronary Angiography (QCA) derived parameters - Cohort A

    Proximal Late Loss (LL) postnitrate

    Time frame: 12 months

  9. Quantitative Coronary Angiography (QCA) derived parameters - Cohort B

    Proximal Late Loss (LL) postnitrate

    Time frame: 24 months

  10. Quantitative Coronary Angiography (QCA) derived parameters - Cohort C

    Proximal Late Loss (LL) postnitrate

    Time frame: 36 months

  11. Quantitative Coronary Angiography (QCA) derived parameters - Cohort A

    Distal Late Loss (LL) postnitrate

    Time frame: 12 months

  12. Quantitative Coronary Angiography (QCA) derived parameters - Cohort B

    Distal Late Loss (LL) postnitrate

    Time frame: 24 months

  13. Quantitative Coronary Angiography (QCA) derived parameters - Cohort C

    Distal Late Loss (LL) postnitrate

    Time frame: 36 months

  14. Quantitative Coronary Angiography (QCA) derived parameters - All cohorts

    In-scaffold/in-stent, in-segment, proximal and distal Minimal Lumen Diameter (MLD) postnitrate

    Time frame: Baseline

  15. Quantitative Coronary Angiography (QCA) derived parameters - Cohort A

    In-scaffold/in-stent, in-segment, proximal and distal Minimal Lumen Diameter (MLD) postnitrate

    Time frame: 12 months

  16. Quantitative Coronary Angiography (QCA) derived parameters - Cohort B

    In-scaffold/in-stent, in-segment, proximal and distal Minimal Lumen Diameter (MLD) postnitrate

    Time frame: 24 months

  17. Quantitative Coronary Angiography (QCA) derived parameters - Cohort C

    In-scaffold/in-stent, in-segment, proximal and distal Minimal Lumen Diameter (MLD) postnitrate

    Time frame: 36 months

  18. Quantitative Coronary Angiography (QCA) derived parameters - All cohorts

    In-scaffold/in-stent, in-segment, proximal and distal % diameter stenosis (DS) postnitrate

    Time frame: Baseline

  19. Quantitative Coronary Angiography (QCA) derived parameters - Cohort A

    In-scaffold/in-stent, in-segment, proximal and distal % diameter stenosis (DS) postnitrate

    Time frame: 12 months

  20. Quantitative Coronary Angiography (QCA) derived parameters - Cohort B

    In-scaffold/in-stent, in-segment, proximal and distal % diameter stenosis (DS) postnitrate

    Time frame: 24 months

  21. Quantitative Coronary Angiography (QCA) derived parameters - Cohort C

    In-scaffold/in-stent, in-segment, proximal and distal % diameter stenosis (DS) postnitrate

    Time frame: 36 months

  22. Quantitative Coronary Angiography (QCA) derived parameters - Cohort A

    In-scaffold/in-stent, in-segment, proximal and distal angiographic binary restenosis rate postnitrate

    Time frame: 12 months

  23. Quantitative Coronary Angiography (QCA) derived parameters - Cohort B

    In-scaffold/in-stent, in-segment, proximal and distal angiographic binary restenosis rate postnitrate

    Time frame: 24 months

  24. Quantitative Coronary Angiography (QCA) derived parameters - Cohort C

    In-scaffold/in-stent, in-segment, proximal and distal angiographic binary restenosis rate postnitrate

    Time frame: 36 months

07

Study locations

1 site
  • Academic Medical Center
    Amsterdam, 1105AZ, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02928198
Lead sponsor
J.J. Wykrzykowska
Collaborators
Abbott Medical Devices
Responsible party
J.J. Wykrzykowska (MD PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)) — Sponsor-investigator
First posted
Oct 10, 2016
Start date
Jun 2016
Primary completion
Mar 2020 (estimated)
Completion
Mar 2020 (estimated)
Last update
Jan 17, 2018

Study contacts

Joanna J Wykrzykowska, MD, PhD
principal investigator · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
View the source record on ClinicalTrials.gov ↗

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