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

Not Applicable

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT02539966
• Lead Sponsor: REVA Medical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-09-01
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-03
• Primary Completion: 2019-08
• Study Completion: 2024-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 272

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Major Adverse Cardiac Events (MACE) - Cohorts A, B and C	6 months	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	6 months	Late Lumen Loss

Secondary Outcome Measures

Name	Time	Method
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B	9 months	Binary Restenosis
Target Lesion Revascularization (TLR) - Cohorts A, B and C	12, 24, 36, 48 and 60 months	Percentage of patients with TLR at each time point
Target Vessel Failure (TVF) - Cohorts A, B and C	12, 24, 36, 48 and 60 months	Percentage of patients with TVF at each time point
Acute Technical Success - Cohorts A, B and C	Day 0	Successful acute delivery and deployment of the device
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C	6 months	Binary Restenosis
Major Adverse Cardiac Events (MACE) - Cohorts A, B and C	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)
Target Vessel Revascularization (TVR) - Cohorts A, B and C	12, 24, 36, 48 and 60 months	Percentage of patients with TVR at each time point
Procedural Success - Cohorts A, B and C	30 days	Percentage of patients with angiographic success (final diameter stenosis \<50% without occurrence of MACE)

Trial Locations

Locations (28)

The Prince Charles Hospital; 🇦🇺 Chermside, Australia

St Vincent's Hospital Sydney; 🇦🇺 Darlinghurst, Australia

Prince of Wales Hospital (Eastern Heart); 🇦🇺 Randwick, Australia

Cardiovascular Center Aalst; 🇧🇪 Aalst, Belgium

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

Albert Einstein Hospital; 🇧🇷 São Paulo, Brazil

Aarhus University Hospital (Skejby); 🇩🇰 Aarhus, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark

institut Hospitalier J.Cartier; 🇫🇷 Massy, France

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