NCT02928198

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

January 17, 2018

Status Verified

January 1, 2018

Enrollment Period

3.8 years

First QC Date

September 9, 2016

Last Update Submit

January 15, 2018

Conditions

Myocardial IschemiaIschemiaCoronary DiseaseHeart DiseasesCardiovascular DiseasesCoronary Bifurcation LesionsArterial Occlusive LesionsInfarctionMyocardial InfarctionArteriosclerosis

Keywords

Tomography, Optical CoherencePercutaneous Coronary InterventionCardiac CatheterizationCoronary Biovascular Scaffold

Outcome Measures

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.

    12 months

Secondary Outcomes (36)

  • Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - All cohorts

    Baseline

  • Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort B

    24 months

  • Number and appearance of jailed side branch struts, as assessed with three-dimensional OCT - Cohort C

    36 months

  • Incomplete strut apposition in the bifurcation region - All cohorts

    Baseline

  • Incomplete strut apposition in the bifurcation region - Cohort A

    12 months

  • +31 more secondary outcomes

Other Outcomes (24)

  • Quantitative Coronary Angiography (QCA) derived parameters - All cohorts

    Baseline

  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort A

    12 months

  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort B

    24 months

  • +21 more other outcomes

Study Arms (2)

Fenestration

ACTIVE COMPARATOR

Fenestration of the Absorb Biovascular Scaffold towards the side-branch

Device: ABSORB BVS

No Fenestration

ACTIVE COMPARATOR

No fenestration of the Absorb Biovascular Scaffold towards the side-branch

Device: ABSORB BVS

Interventions

ABSORB BVSDEVICE
FenestrationNo Fenestration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academic Medical Center

Amsterdam, 1105AZ, Netherlands

Location

MeSH Terms

Conditions

Myocardial IschemiaIschemiaCoronary DiseaseHeart DiseasesCardiovascular DiseasesInfarctionMyocardial InfarctionArteriosclerosis

Condition Hierarchy (Ancestors)

Vascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisArterial Occlusive Diseases

Study Officials

  • Joanna J Wykrzykowska, MD, PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

September 9, 2016

First Posted

October 10, 2016

Study Start

June 1, 2016

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

January 17, 2018

Record last verified: 2018-01

Locations

NL(1)