Skip to main content
OpenTrials
Completed

NCT Number: NCT02539966

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

The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Prince Charles Hospital, Chermside, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold

Device

Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease

Primary outcomes

  1. 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)

  2. Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C

    Time frame: 6 months

    Late Lumen Loss

Secondary outcomes

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

    Time frame: 9 months

    Late Lumen Loss

  2. Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C

    Time frame: 6 months

    Minimum Lumen Diameter (MLD)

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

    Time frame: 9 months

    Minimum Lumen Diameter (MLD)

  4. Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C

    Time frame: 6 months

    % Diameter Stenosis

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

    Time frame: 9 months

    % Diameter Stenosis

  6. Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C

    Time frame: 6 months

    Binary Restenosis

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

    Time frame: 9 months

    Binary Restenosis

  8. 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)

  9. 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

  10. 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

  11. 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

  12. Acute Technical Success - Cohorts A, B and C

    Time frame: Day 0

    Successful acute delivery and deployment of the device

  13. 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)

Sponsors and collaborators

Lead sponsor

REVA Medical, Inc.

Industry

Registry information

Acronym: FANTOM II

Important dates

Study start
2015
Primary completion
2019
Study completion
2024
First posted
Sep 3, 2015
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.