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Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold (FANTOM II)

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ClinicalTrials.gov Identifier: NCT02539966
Recruitment Status : Recruiting
First Posted : September 3, 2015
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
REVA Medical, Inc.

Tracking Information
First Submitted Date  ICMJE September 1, 2015
First Posted Date  ICMJE September 3, 2015
Last Update Posted Date November 14, 2017
Actual Study Start Date  ICMJE March 2015
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2017)
  • Major Adverse Cardiac Events (MACE) - Cohorts A, B and C [ Time Frame: 6 months ]
    Cardiac Death, Myocardial Infarction (Q-Wave, Non Q-wave: CK-MB >5X ULN) (MI), and target lesion revascularization (TLR)
  • Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C [ Time Frame: 6 months ]
    Late Lumen Loss
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2015)
  • Major Adverse Cardiac Events (MACE) - Cohort A and B [ Time Frame: 6 months ]
    Cardiac Death, Myocardial Infarction (Q-Wave, Non Q-wave: CK-MB >5X ULN) (MI), and target lesion revascularization (TLR)
  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort A [ Time Frame: 6 months ]
    Late Lumen Loss
Change History Complete list of historical versions of study NCT02539966 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2017)
  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort B [ Time Frame: 9 months ]
    Late Lumen Loss
  • Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C [ Time Frame: 6 months ]
    Minimum Lumen Diameter (MLD)
  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort B [ Time Frame: 9 months ]
    Minimum Lumen Diameter (MLD)
  • Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C [ Time Frame: 6 months ]
    % Diameter Stenosis
  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort B [ Time Frame: 9 months ]
    % Diameter Stenosis
  • Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C [ Time Frame: 6 months ]
    Binary Restenosis
  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort B [ Time Frame: 9 months ]
    Binary Restenosis
  • Major Adverse Cardiac Events (MACE) - Cohorts A, B and C [ Time Frame: 12, 24, 36, 48 and 60 months ]
    Cardiac Death, Myocardial Infarction (Q-Wave, Non Q-wave: CK-MB >5X ULN) (MI), and target lesion revascularization (TLR)
  • Target Lesion Revascularization (TLR) - Cohorts A, B and C [ Time Frame: 12, 24, 36, 48 and 60 months ]
    Percentage of patients with TLR at each time point
  • Target Vessel Revascularization (TVR) - Cohorts A, B and C [ Time Frame: 12, 24, 36, 48 and 60 months ]
    Percentage of patients with TVR at each time point
  • Target Vessel Failure (TVF) - Cohorts A, B and C [ Time Frame: 12, 24, 36, 48 and 60 months ]
    Percentage of patients with TVF at each time point
  • Acute Technical Success - Cohorts A, B and C [ Time Frame: Day 0 ]
    Successful acute delivery and deployment of the device
  • Procedural Success - Cohorts A, B and C [ Time Frame: 30 days ]
    Percentage of patients with angiographic success (final diameter stenosis <50% without occurrence of MACE)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2015)
  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort B [ Time Frame: 9 months ]
    Late Lumen Loss
  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort A [ Time Frame: 6 months ]
    Minimum Lumen Diameter (MLD)
  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort B [ Time Frame: 9 months ]
    Minimum Lumen Diameter (MLD)
  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort A [ Time Frame: 6 months ]
    % Diameter Stenosis
  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort B [ Time Frame: 9 months ]
    % Diameter Stenosis
  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort A [ Time Frame: 6 months ]
    Binary Restenosis
  • Quantitative Coronary Angiography (QCA) derived parameters - Cohort B [ Time Frame: 9 months ]
    Binary Restenosis
  • Major Adverse Cardiac Events (MACE) - Cohort A and B [ Time Frame: 12, 24, 36, 48 and 60 months ]
    Cardiac Death, Myocardial Infarction (Q-Wave, Non Q-wave: CK-MB >5X ULN) (MI), and target lesion revascularization (TLR)
  • Target Lesion Revascularization (TLR) - Cohort A and B [ Time Frame: 12, 24, 36, 48 and 60 months ]
    Percentage of patients with TLR at each time point
  • Target Vessel Revascularization (TVR) - Cohort A and B [ Time Frame: 12, 24, 36, 48 and 60 months ]
    Percentage of patients with TVR at each time point
  • Target Vessel Failure (TVF) - Cohort A and B [ Time Frame: 12, 24, 36, 48 and 60 months ]
    Percentage of patients with TVF at each time point
  • Acute Technical Success - Cohort A and B [ Time Frame: Day 0 ]
    Successful acute delivery and deployment of the device
  • Procedural Success - Cohort A and B [ Time Frame: 30 days ]
    Percentage of patients with angiographic success (final diameter stenosis <50% without occurrence of MACE)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
Official Title  ICMJE Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
Brief Summary The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease
Study Arms  ICMJE
  • Experimental: Cohort A
    Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group A (6-month angiographic follow-up)
    Intervention: Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
  • Experimental: Cohort B
    Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group B (9-month angiographic follow-up)
    Intervention: Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
  • Experimental: Cohort C
    Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group C (6-month angiographic follow-up), Long Lesion/Multi-Vessel
    Intervention: Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Publications * Chevalier B, Abizaid A, Carrié 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 1, 2015)
220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jeffrey Anderson 858-966-3038 janderson@revamedical.com
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Denmark,   France,   Germany,   Netherlands,   Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02539966
Other Study ID Numbers  ICMJE HCT6200
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party REVA Medical, Inc.
Study Sponsor  ICMJE REVA Medical, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Alexandre Abizaid, MD, PhD Instituto Dante Pazzanese de Cardiologia
Principal Investigator: Christoph K Naber, PD Dr. med Elisabeth-Krankenhaus Essen
PRS Account REVA Medical, Inc.
Verification Date November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP