Pilot Study of the Fantom Bioresorbable Scaffold (FANTOM I)

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: Fantom Scaffold

• Registration Number: NCT02512003
• Lead Sponsor: REVA Medical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Primary Completion: 2015-07
• Study First Submitted: 2015-07-14
• Study First Submitted QC: 2015-07-28
• Study First Posted: 2015-07-30
• Study Completion: 2020-04
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fantom Treatment group	Fantom Scaffold	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Instituto Dante Pazzanese de Cardiologia; 🇧🇷 Sao Paulo, Brazil

Pracownia Kardiologii Inwazyjnej I Katedry i Kliniki Kardiologii WUM; 🇵🇱 Warszawa, Poland