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

March 27, 2023 updated by: REVA Medical, Inc.
The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Chermside, Australia
        • The Prince Charles Hospital
      • Darlinghurst, Australia
        • St Vincent'S Hospital Sydney
      • Randwick, Australia
        • Prince of Wales Hospital (Eastern Heart)
  • Belgium
      • Aalst, Belgium
        • Cardiovascular Center Aalst
  • Brazil
      • Sao Paulo, Brazil
        • Instituto Dante Pazzanese de Cardiologia
      • São Paulo, Brazil
        • Albert Einstein Hospital
  • Denmark
      • Aarhus, Denmark
        • Aarhus University Hospital (Skejby)
      • Copenhagen, Denmark
        • Rigshospitalet
      • Odense, Denmark
        • Odense University Hospital
  • France
      • Massy, France
        • institut Hospitalier J.Cartier
      • Paris, France
        • La Pitié-Salpêtrière
      • Toulouse, France
        • Hopital Rangueil
      • Toulouse, France
        • Clinique PASTEUR
  • Germany
      • Berlin, Germany
        • Am Urban Hospital, Berlin
      • Berlin, Germany
        • Friedrichshein Hospital, Berlin
      • Coburg, Germany
        • Klinikum Coburg
      • Dortmund, Germany
        • St.- Johannes-Hospital Dortmund
      • Erlangen, Germany
        • Universitätsklinikum Erlangen
      • Essen, Germany
        • Elisabeth-Krankenhaus Essen
      • Kiel, Germany
        • Universitätsklinikum Schleswig-Holstein
  • Netherlands
      • Amsterdam, Netherlands
        • Onze Lieve Vrouwe Gasthuis
      • Amsterdam, Netherlands
        • Academic Medical Center Amsterdam
      • Rotterdam, Netherlands
        • Erasmus Medical Center
      • Utrecht, Netherlands
        • University Medical Center Utrecht
  • Poland
      • Krakow, Poland
        • Szpital Uniwersytecki w Krakowie
      • Krakow, Poland
        • Krakowskie Centrum Kardiologii Inwazyjnej
      • Poznan, Poland
        • Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu
      • Warszawa, Poland
        • Oddział Kardiologii Inwazyjnej I Katedra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group A (6-month angiographic follow-up)
Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease
Experimental: Cohort B
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group B (9-month angiographic follow-up)
Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease
Experimental: Cohort C
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group C (6-month angiographic follow-up), Long Lesion/Multi-Vessel
Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
6 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
Time Frame: 6 months
Late Lumen Loss
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Time Frame: 9 months
Late Lumen Loss
9 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
Time Frame: 6 months
Minimum Lumen Diameter (MLD)
6 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Time Frame: 9 months
Minimum Lumen Diameter (MLD)
9 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
Time Frame: 6 months
% Diameter Stenosis
6 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Time Frame: 9 months
% Diameter Stenosis
9 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
Time Frame: 6 months
Binary Restenosis
6 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Time Frame: 9 months
Binary Restenosis
9 months
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)
12, 24, 36, 48 and 60 months
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
12, 24, 36, 48 and 60 months
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
12, 24, 36, 48 and 60 months
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, 24, 36, 48 and 60 months
Acute Technical Success - Cohorts A, B and C
Time Frame: Day 0
Successful acute delivery and deployment of the device
Day 0
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)
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

REVA Medical, Inc.

Investigators

  • Principal Investigator: Alexandre Abizaid, MD, PhD, Instituto Dante Pazzanese de Cardiologia
  • Principal Investigator: Christoph K Naber, PD Dr. med, Elisabeth-Krankenhaus Essen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

August 1, 2019

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

September 1, 2015

First Submitted That Met QC Criteria

September 1, 2015

First Posted (Estimate)

September 3, 2015

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HCT6200

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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