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

Primary Purpose

Coronary Artery Disease

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Sponsored by
REVA Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Prince Charles Hospital
  • St Vincent's Hospital Sydney
  • Prince of Wales Hospital (Eastern Heart)
  • Cardiovascular Center Aalst
  • Instituto Dante Pazzanese de Cardiologia
  • Albert Einstein Hospital
  • Aarhus University Hospital (Skejby)
  • Rigshospitalet
  • Odense University Hospital
  • institut Hospitalier J.Cartier
  • La Pitié-Salpétrière
  • Clinique Pasteur
  • Hôpital Rangueil
  • Am Urban Hospital, Berlin
  • Friedrichshein Hospital, Berlin
  • Klinikum Coburg
  • St.- Johannes-Hospital Dortmund
  • Universitätsklinikum Erlangen
  • Elisabeth-Krankenhaus Essen
  • Universitätsklinikum Schleswig-Holstein
  • Academic Medical Center Amsterdam
  • Onze Lieve Vrouwe Gasthuis
  • Erasmus Medical Center
  • University Medical Center Utrecht
  • Krakowskie Centrum Kardiologii Inwazyjnej
  • Szpital Uniwersytecki w Krakowie
  • Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu
  • Oddział Kardiologii Inwazyjnej I Katedra

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort A

Cohort B

Cohort C

Arm Description

Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group A (6-month angiographic follow-up)

Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group B (9-month angiographic follow-up)

Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group C (6-month angiographic follow-up), Long Lesion/Multi-Vessel

Outcomes

Primary Outcome Measures

Major Adverse Cardiac Events (MACE) - Cohorts A, B and C
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
Late Lumen Loss

Secondary Outcome Measures

Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Late Lumen Loss
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
Minimum Lumen Diameter (MLD)
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Minimum Lumen Diameter (MLD)
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
% Diameter Stenosis
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
% Diameter Stenosis
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
Binary Restenosis
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Binary Restenosis
Major Adverse Cardiac Events (MACE) - Cohorts A, B and C
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
Percentage of patients with TLR at each time point
Target Vessel Revascularization (TVR) - Cohorts A, B and C
Percentage of patients with TVR at each time point
Target Vessel Failure (TVF) - Cohorts A, B and C
Percentage of patients with TVF at each time point
Acute Technical Success - Cohorts A, B and C
Successful acute delivery and deployment of the device
Procedural Success - Cohorts A, B and C
Percentage of patients with angiographic success (final diameter stenosis <50% without occurrence of MACE)

Full Information

First Posted
September 1, 2015
Last Updated
March 27, 2023
Sponsor
REVA Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02539966
Brief Title
Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
Acronym
FANTOM II
Official Title
Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2015 (Actual)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
REVA Medical, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A
Arm Type
Experimental
Arm Description
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group A (6-month angiographic follow-up)
Arm Title
Cohort B
Arm Type
Experimental
Arm Description
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group B (9-month angiographic follow-up)
Arm Title
Cohort C
Arm Type
Experimental
Arm Description
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group C (6-month angiographic follow-up), Long Lesion/Multi-Vessel
Intervention Type
Device
Intervention Name(s)
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Intervention Description
Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease
Primary Outcome Measure Information:
Title
Major Adverse Cardiac Events (MACE) - Cohorts A, B and C
Description
Cardiac Death, Myocardial Infarction (Q-Wave, Non Q-wave: CK-MB >5X ULN) (MI), and target lesion revascularization (TLR)
Time Frame
6 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
Description
Late Lumen Loss
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Description
Late Lumen Loss
Time Frame
9 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
Description
Minimum Lumen Diameter (MLD)
Time Frame
6 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Description
Minimum Lumen Diameter (MLD)
Time Frame
9 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
Description
% Diameter Stenosis
Time Frame
6 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Description
% Diameter Stenosis
Time Frame
9 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
Description
Binary Restenosis
Time Frame
6 months
Title
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Description
Binary Restenosis
Time Frame
9 months
Title
Major Adverse Cardiac Events (MACE) - Cohorts A, B and C
Description
Cardiac Death, Myocardial Infarction (Q-Wave, Non Q-wave: CK-MB >5X ULN) (MI), and target lesion revascularization (TLR)
Time Frame
12, 24, 36, 48 and 60 months
Title
Target Lesion Revascularization (TLR) - Cohorts A, B and C
Description
Percentage of patients with TLR at each time point
Time Frame
12, 24, 36, 48 and 60 months
Title
Target Vessel Revascularization (TVR) - Cohorts A, B and C
Description
Percentage of patients with TVR at each time point
Time Frame
12, 24, 36, 48 and 60 months
Title
Target Vessel Failure (TVF) - Cohorts A, B and C
Description
Percentage of patients with TVF at each time point
Time Frame
12, 24, 36, 48 and 60 months
Title
Acute Technical Success - Cohorts A, B and C
Description
Successful acute delivery and deployment of the device
Time Frame
Day 0
Title
Procedural Success - Cohorts A, B and C
Description
Percentage of patients with angiographic success (final diameter stenosis <50% without occurrence of MACE)
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandre Abizaid, MD, PhD
Organizational Affiliation
Instituto Dante Pazzanese de Cardiologia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christoph K Naber, PD Dr. med
Organizational Affiliation
Elisabeth-Krankenhaus Essen
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Prince Charles Hospital
City
Chermside
Country
Australia
Facility Name
St Vincent's Hospital Sydney
City
Darlinghurst
Country
Australia
Facility Name
Prince of Wales Hospital (Eastern Heart)
City
Randwick
Country
Australia
Facility Name
Cardiovascular Center Aalst
City
Aalst
Country
Belgium
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
Sao Paulo
Country
Brazil
Facility Name
Albert Einstein Hospital
City
São Paulo
Country
Brazil
Facility Name
Aarhus University Hospital (Skejby)
City
Aarhus
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Odense University Hospital
City
Odense
Country
Denmark
Facility Name
institut Hospitalier J.Cartier
City
Massy
Country
France
Facility Name
La Pitié-Salpétrière
City
Paris
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
Country
France
Facility Name
Hôpital Rangueil
City
Toulouse
Country
France
Facility Name
Am Urban Hospital, Berlin
City
Berlin
Country
Germany
Facility Name
Friedrichshein Hospital, Berlin
City
Berlin
Country
Germany
Facility Name
Klinikum Coburg
City
Coburg
Country
Germany
Facility Name
St.- Johannes-Hospital Dortmund
City
Dortmund
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
Country
Germany
Facility Name
Elisabeth-Krankenhaus Essen
City
Essen
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Kiel
Country
Germany
Facility Name
Academic Medical Center Amsterdam
City
Amsterdam
Country
Netherlands
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Facility Name
University Medical Center Utrecht
City
Utrecht
Country
Netherlands
Facility Name
Krakowskie Centrum Kardiologii Inwazyjnej
City
Krakow
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie
City
Krakow
Country
Poland
Facility Name
Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu
City
Poznan
Country
Poland
Facility Name
Oddział Kardiologii Inwazyjnej I Katedra
City
Warszawa
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
31177821
Citation
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.
Results Reference
derived

Learn more about this trial

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

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