Pilot Study of the Fantom Bioresorbable Scaffold (FANTOM I)

N/ACompletedNCT02512003

REVA Medical, Inc.7 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Coronary Artery Disease

Interventions

Fantom ScaffoldDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Pracownia Kardiologii Inwazyjnej I Katedry i Kliniki Kardiologii WUM

Warsaw, Poland

Outcomes

Primary Outcomes

Ischemia-driven Target Lesion Revascularization (TLR)

Percent of Patients with TLR at 4 months

Time frame: 4 months