Pilot Study of the Fantom Bioresorbable Scaffold (FANTOM I)

REVA Medical

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Device: Fantom Scaffold

Study type: Interventional

Funder types: Industry

Identifiers

NCT02512003

HCT6000

Details and patient eligibility

About

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

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Fantom Treatment group

Experimental group

Treatment:

Device: Fantom Scaffold