Clinical trial NCT02928198: Bifurcation ABSORB OCT Trial
Official title: Bifurcation ABSORB OCT Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
Collaborators: name: Abbott Medical Devices
First posted: 2016-10-10
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort A
timeFrame: 12 months
Secondary outcomes:
measure: Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - All cohorts
timeFrame: Baseline
measure: Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort B
timeFrame: 24 months
measure: Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort C
timeFrame: 36 months
measure: Incomplete strut apposition in the bifurcation region - All cohorts
timeFrame: Baseline
measure: Incomplete strut apposition in the bifurcation region - Cohort A
timeFrame: 12 months
measure: Incomplete strut apposition in the bifurcation region - Cohort B
timeFrame: 24 months
measure: Incomplete strut apposition in the bifurcation region - Cohort C
timeFrame: 36 months
measure: Number of embedded and protruded ABSORB BVS struts per region - All cohorts
timeFrame: Baseline
measure: Number of embedded and protruded ABSORB BVS struts per region - Cohort A
timeFrame: 12 months
measure: Number of embedded and protruded ABSORB BVS struts per region - Cohort B
timeFrame: 24 months
measure: Number of embedded and protruded ABSORB BVS struts per region - Cohort C
timeFrame: 36 months
measure: Incomplete strut coverage in the bifurcation region - Cohort A
timeFrame: 12 months
measure: Incomplete strut coverage in the bifurcation region - Cohort B
timeFrame: 24 months
measure: Incomplete strut coverage in the bifurcation region - Cohort C
timeFrame: 36 months
measure: The number of non-apposed side branch (NASB) struts - All cohorts
timeFrame: Baseline
measure: The number of non-apposed side branch (NASB) struts - Cohort A
timeFrame: 12 months
measure: The number of non-apposed side branch (NASB) struts - Cohort B
timeFrame: 24 months
measure: The number of non-apposed side branch (NASB) struts - Cohort C
timeFrame: 36 months
measure: Tissue in-between non-apposed side branch (NASB) struts - Cohort A
timeFrame: 12 months
measure: Tissue in-between non-apposed side branch (NASB) struts - Cohort B
timeFrame: 24 months
measure: Tissue in-between non-apposed side branch (NASB) struts - Cohort C
timeFrame: 36 months
measure: Mean/Minimal Lumen diameter/area - All cohorts
timeFrame: Baseline
measure: Mean/Minimal Lumen diameter/area - Cohort A
timeFrame: 12 months
measure: Mean/Minimal Lumen diameter/area - Cohort B
timeFrame: 24 months
measure: Mean/Minimal Lumen diameter/area - Cohort C
timeFrame: 36 months
measure: Mean/Minimal Scaffold diameter/area - All cohorts
timeFrame: Baseline
measure: Mean/Minimal Scaffold diameter/area - Cohort A
timeFrame: 12 months
measure: Mean/Minimal Scaffold diameter/area - Cohort B
timeFrame: 24 months
measure: Mean/Minimal Scaffold diameter/area - Cohort C
timeFrame: 36 months
measure: Neointima thickness - Cohort A
timeFrame: 12 months
measure: Neointima thickness - Cohort B
timeFrame: 24 months
measure: Neointima thickness - Cohort C
timeFrame: 36 months
measure: Scaffold pattern irregularities - All cohorts
timeFrame: Baseline
measure: Scaffold pattern irregularities - Cohort A
timeFrame: 12 months
measure: Scaffold pattern irregularities - Cohort B
timeFrame: 24 months
measure: Scaffold pattern irregularities - Cohort C
timeFrame: 36 months
Other outcomes:
measure: Quantitative Coronary Angiography (QCA) derived parameters - All cohorts
timeFrame: Baseline
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort A
timeFrame: 12 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
timeFrame: 24 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort C
timeFrame: 36 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort A
timeFrame: 12 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
timeFrame: 24 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort C
timeFrame: 36 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort A
timeFrame: 12 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
timeFrame: 24 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort C
timeFrame: 36 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort A
timeFrame: 12 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
timeFrame: 24 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort C
timeFrame: 36 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - All cohorts
timeFrame: Baseline
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort A
timeFrame: 12 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
timeFrame: 24 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort C
timeFrame: 36 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - All cohorts
timeFrame: Baseline
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort A
timeFrame: 12 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
timeFrame: 24 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort C
timeFrame: 36 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort A
timeFrame: 12 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
timeFrame: 24 months
measure: Quantitative Coronary Angiography (QCA) derived parameters - Cohort C
timeFrame: 36 months
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Joanna J Wykrzykowska, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: