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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02539966
Registration number
NCT02539966
Ethics application status
Date submitted
1/09/2015
Date registered
3/09/2015
Date last updated
14/06/2024
Titles & IDs
Public title
Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
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Scientific title
Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
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Secondary ID [1]
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HCT6200
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Universal Trial Number (UTN)
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Trial acronym
FANTOM II
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Experimental: Cohort A - Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group A (6-month angiographic follow-up)
Experimental: Cohort B - Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group B (9-month angiographic follow-up)
Experimental: Cohort C - Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group C (6-month angiographic follow-up), Long Lesion/Multi-Vessel
Treatment: Devices: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Major Adverse Cardiac Events (MACE) - Cohorts A, B and C
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Assessment method [1]
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Cardiac Death, Myocardial Infarction (Q-Wave, Non Q-wave: CK-MB \>5X ULN) (MI), and target lesion revascularization (TLR)
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Timepoint [1]
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6 months
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Primary outcome [2]
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Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
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Assessment method [2]
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Late Lumen Loss
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Timepoint [2]
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6 months
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Secondary outcome [1]
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Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
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Assessment method [1]
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Late Lumen Loss
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Timepoint [1]
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9 months
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Secondary outcome [2]
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Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
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Assessment method [2]
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Minimum Lumen Diameter (MLD)
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Timepoint [2]
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6 months
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Secondary outcome [3]
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Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
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Assessment method [3]
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Minimum Lumen Diameter (MLD)
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Timepoint [3]
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9 months
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Secondary outcome [4]
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Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
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Assessment method [4]
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% Diameter Stenosis
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Timepoint [4]
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6 months
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Secondary outcome [5]
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Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
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Assessment method [5]
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% Diameter Stenosis
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Timepoint [5]
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9 months
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Secondary outcome [6]
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Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
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Assessment method [6]
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Binary Restenosis
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Timepoint [6]
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6 months
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Secondary outcome [7]
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Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
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Assessment method [7]
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Binary Restenosis
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Timepoint [7]
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9 months
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Secondary outcome [8]
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Major Adverse Cardiac Events (MACE) - Cohorts A, B and C
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Assessment method [8]
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Cardiac Death, Myocardial Infarction (Q-Wave, Non Q-wave: CK-MB \>5X ULN) (MI), and target lesion revascularization (TLR)
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Timepoint [8]
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12, 24, 36, 48 and 60 months
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Secondary outcome [9]
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Target Lesion Revascularization (TLR) - Cohorts A, B and C
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Assessment method [9]
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Percentage of patients with TLR at each time point
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Timepoint [9]
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12, 24, 36, 48 and 60 months
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Secondary outcome [10]
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Target Vessel Revascularization (TVR) - Cohorts A, B and C
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Assessment method [10]
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Percentage of patients with TVR at each time point
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Timepoint [10]
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12, 24, 36, 48 and 60 months
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Secondary outcome [11]
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Target Vessel Failure (TVF) - Cohorts A, B and C
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Assessment method [11]
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Percentage of patients with TVF at each time point
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Timepoint [11]
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12, 24, 36, 48 and 60 months
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Secondary outcome [12]
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Acute Technical Success - Cohorts A, B and C
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Assessment method [12]
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Successful acute delivery and deployment of the device
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Timepoint [12]
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Day 0
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Secondary outcome [13]
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Procedural Success - Cohorts A, B and C
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Assessment method [13]
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Percentage of patients with angiographic success (final diameter stenosis \<50% without occurrence of MACE)
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Timepoint [13]
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30 days
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Eligibility
Key inclusion criteria
* Patient has evidence of myocardial ischemia or a positive functional study
* Target lesion has a visually estimated stenosis of =50% and <100%
* Target lesion is located in a native coronary artery with average reference vessel diameter = 2.5mm and = 3.5mm
* Lesion length = 20 mm by visual estimate (N/A for Cohort C)
* Baseline TIMI flow = 2
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* The patient has experienced an acute myocardial infarction (AMI: STEMI or NSTEMI) within 72 hours of the procedure and either CK-MB or Troponin has not returned to within 2X ULN.
* Patient has a left ventricular ejection fraction < 40%
* Patient has unprotected left main coronary disease with =50% stenosis
* The target vessel is totally occluded (TIMI Flow 0 or 1)
* Target lesion involves a bifurcation (a lesion with a side branch = 1.5 mm in diameter containing a = 50% stenosis).
* Target lesion is located within a bypass graft
* Target lesion has possible or definite thrombus
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2024
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Actual
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Sample size
Target
220
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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The Prince Charles Hospital - Chermside
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Recruitment hospital [2]
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St Vincent's Hospital Sydney - Darlinghurst
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Recruitment hospital [3]
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Prince of Wales Hospital (Eastern Heart) - Randwick
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Recruitment postcode(s) [1]
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- Chermside
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Recruitment postcode(s) [2]
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- Darlinghurst
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Recruitment postcode(s) [3]
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- Randwick
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Recruitment outside Australia
Country [1]
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Belgium
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State/province [1]
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Aalst
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Brazil
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State/province [2]
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Sao Paulo
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Brazil
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State/province [3]
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São Paulo
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Denmark
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State/province [4]
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Aarhus
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Country [5]
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Denmark
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State/province [5]
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Copenhagen
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Country [6]
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Denmark
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State/province [6]
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Odense
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Country [7]
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France
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State/province [7]
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Massy
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Country [8]
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France
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State/province [8]
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Paris
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Country [9]
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France
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State/province [9]
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Toulouse
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Germany
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State/province [10]
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Berlin
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Germany
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State/province [11]
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Coburg
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Country [12]
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Germany
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State/province [12]
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Dortmund
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Country [13]
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Germany
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State/province [13]
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Erlangen
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Germany
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State/province [14]
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Essen
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Germany
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State/province [15]
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Kiel
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Country [16]
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Netherlands
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State/province [16]
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Amsterdam
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Netherlands
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State/province [17]
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Rotterdam
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Netherlands
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State/province [18]
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Utrecht
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Country [19]
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Poland
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State/province [19]
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Krakow
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Poland
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State/province [20]
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Poznan
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Country [21]
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Poland
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State/province [21]
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Warszawa
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
REVA Medical, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.
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Trial website
https://clinicaltrials.gov/study/NCT02539966
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Trial related presentations / publications
Chevalier B, Abizaid A, Carrie D, Frey N, Lutz M, Weber-Albers J, Dudek D, Weng SC, Akodad M, Anderson J, Stone GW. Clinical and Angiographic Outcomes With a Novel Radiopaque Sirolimus-Eluting Bioresorbable Vascular Scaffold. Circ Cardiovasc Interv. 2019 Jun;12(6):e007283. doi: 10.1161/CIRCINTERVENTIONS.118.007283. Epub 2019 Jun 10.
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Public notes
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Contacts
Principal investigator
Name
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Alexandre Abizaid, MD, PhD
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Address
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Instituto Dante Pazzanese de Cardiologia
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02539966
Download to PDF