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Pilot Study of the Fantom Bioresorbable Scaffold (FANTOM I) (FANTOM I)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Fantom 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
  • Patient has a normal CK-MB
  • 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 ≥ 2.7mm and ≤ 3.3mm
  • Target lesion length must be ≤ 14mm

Exclusion Criteria:

  • Patient has experienced a myocardial infarction (CK-MB or Troponin > 5 X ULN) within 72 hours of the procedure
  • Patient has a left ventricular ejection fraction < 25%
  • Patient has unprotected lest 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 ≥ 2.0 mm in diameter containing a ≥ 50% stenosis).
  • Target lesion is located within a bypass graft
  • Target lesion has possible or definite thrombus

Sites / Locations

  • Instituto Dante Pazzanese de Cardiologia
  • Pracownia Kardiologii Inwazyjnej I Katedry i Kliniki Kardiologii WUM

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fantom Treatment group

Arm Description

Outcomes

Primary Outcome Measures

Ischemia-driven Target Lesion Revascularization (TLR)
Percent of Patients with TLR at 4 months

Secondary Outcome Measures

Quantitative Coronary Angiography (QCA) derived parameters
Late Loss
Quantitative Coronary Angiography (QCA) derived parameters
Restenosis Rate
Quantitative Coronary Angiography (QCA) derived parameters
% Diameter Stenosis
Quantitative Coronary Angiography (QCA) derived parameters
Minimum Lumen Diameter
Quantitative Coronary Angiography (QCA) derived parameters
Neointimal Volume
Intravascular Ultrasound (IVUS) derived parameters
Late Loss
Intravascular Ultrasound (IVUS) derived parameters
Restenosis Rate
Intravascular Ultrasound (IVUS) derived parameters
% Diameter Stenosis
Intravascular Ultrasound (IVUS) derived parameters
Minimum Lumen Diameter
Intravascular Ultrasound (IVUS) derived parameters
Neointimal Volume
Major Adverse Cardiac Events
Death, Q-Wave Myocardial Infarction, Non Q-Wave Myocardial Infarction (CK-MB > 5x normal), Target Vessel Revascularization
Target Lesion Revascularization (TLR)
Percentage of patients with TLR at each time point
Target Vessel Revascularization
Percentage of patients with TVR at each time point
Target Vessel Failure (TVF)
Percentage of patients with TVF at each time point
Acute Technical Success
Percentage of patients with successful acute delivery and deployment of the device
Procedural Success
Percentage of patients with angiographic success (final diameter stenosis <50% without occurrence of MACE)
Optical Coherence Tomography (OCT) Imaging on a Subset of Patients
Qualitative measures in a subset of patients

Full Information

First Posted
July 14, 2015
Last Updated
March 27, 2023
Sponsor
REVA Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02512003
Brief Title
Pilot Study of the Fantom Bioresorbable Scaffold (FANTOM I)
Acronym
FANTOM I
Official Title
Pilot Study of the REVA Sirolimus-Eluting Bioresorbable Coronary Scaffold
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
April 2020 (Actual)

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 I pilot study is intended to assess safety 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
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fantom Treatment group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Fantom Scaffold
Primary Outcome Measure Information:
Title
Ischemia-driven Target Lesion Revascularization (TLR)
Description
Percent of Patients with TLR at 4 months
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Quantitative Coronary Angiography (QCA) derived parameters
Description
Late Loss
Time Frame
4 months
Title
Quantitative Coronary Angiography (QCA) derived parameters
Description
Restenosis Rate
Time Frame
4 months
Title
Quantitative Coronary Angiography (QCA) derived parameters
Description
% Diameter Stenosis
Time Frame
4 months
Title
Quantitative Coronary Angiography (QCA) derived parameters
Description
Minimum Lumen Diameter
Time Frame
4 months
Title
Quantitative Coronary Angiography (QCA) derived parameters
Description
Neointimal Volume
Time Frame
4 months
Title
Intravascular Ultrasound (IVUS) derived parameters
Description
Late Loss
Time Frame
4 months
Title
Intravascular Ultrasound (IVUS) derived parameters
Description
Restenosis Rate
Time Frame
4 months
Title
Intravascular Ultrasound (IVUS) derived parameters
Description
% Diameter Stenosis
Time Frame
4 months
Title
Intravascular Ultrasound (IVUS) derived parameters
Description
Minimum Lumen Diameter
Time Frame
4 months
Title
Intravascular Ultrasound (IVUS) derived parameters
Description
Neointimal Volume
Time Frame
4 months
Title
Major Adverse Cardiac Events
Description
Death, Q-Wave Myocardial Infarction, Non Q-Wave Myocardial Infarction (CK-MB > 5x normal), Target Vessel Revascularization
Time Frame
12, 24, 36, 48 and 60 months
Title
Target Lesion Revascularization (TLR)
Description
Percentage of patients with TLR at each time point
Time Frame
12, 24, 36, 48 and 60 months
Title
Target Vessel Revascularization
Description
Percentage of patients with TVR at each time point
Time Frame
12, 24, 36, 48 and 60 months
Title
Target Vessel Failure (TVF)
Description
Percentage of patients with TVF at each time point
Time Frame
12, 24, 36, 48 and 60 months
Title
Acute Technical Success
Description
Percentage of patients with successful acute delivery and deployment of the device
Time Frame
Day 0
Title
Procedural Success
Description
Percentage of patients with angiographic success (final diameter stenosis <50% without occurrence of MACE)
Time Frame
30 days
Title
Optical Coherence Tomography (OCT) Imaging on a Subset of Patients
Description
Qualitative measures in a subset of patients
Time Frame
4 months

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 Patient has a normal CK-MB 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 ≥ 2.7mm and ≤ 3.3mm Target lesion length must be ≤ 14mm Exclusion Criteria: Patient has experienced a myocardial infarction (CK-MB or Troponin > 5 X ULN) within 72 hours of the procedure Patient has a left ventricular ejection fraction < 25% Patient has unprotected lest 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 ≥ 2.0 mm in diameter containing a ≥ 50% stenosis). Target lesion is located within a bypass graft Target lesion has possible or definite thrombus
Facility Information:
Facility Name
Instituto Dante Pazzanese de Cardiologia
City
Sao Paulo
Country
Brazil
Facility Name
Pracownia Kardiologii Inwazyjnej I Katedry i Kliniki Kardiologii WUM
City
Warszawa
Country
Poland

12. IPD Sharing Statement

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Pilot Study of the Fantom Bioresorbable Scaffold (FANTOM I)

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