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

REVA Medical

Status: Active, not recruiting

Conditions: Coronary Artery Disease

Treatments: Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold

Study type: Interventional

Funder types: Industry

Identifiers

NCT02539966

HCT6200

Details and patient eligibility

About

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

Enrollment: 220 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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220 participants in 3 patient groups

Cohort A

Experimental group

Description:

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

Treatment:

Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold

Cohort B

Experimental group

Description:

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

Treatment:

Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold

Cohort C

Experimental group

Description:

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

Treatment:

Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold