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

Pilot Study of the REVA Sirolimus-Eluting Bioresorbable Coronary Scaffold

The FANTOM I pilot study is intended to assess safety of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Fantom Scaffold

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Instituto Dante Pazzanese de Cardiologia
• Poland
  • Warszawa, Poland
    • Pracownia Kardiologii Inwazyjnej I Katedry i Kliniki Kardiologii WUM

Participation Criteria

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fantom Treatment group	Device: Fantom Scaffold

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ischemia-driven Target Lesion Revascularization (TLR)	Percent of Patients with TLR at 4 months	4 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: REVA Medical, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: July 14, 2015
• First Submitted That Met QC Criteria: July 28, 2015
• First Posted (Estimate): July 30, 2015

Study Record Updates

• Last Update Posted (Actual): March 29, 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: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: HCT6000