Coronary Artery Disease
Conditions
Brief summary
The FANTOM I pilot study is intended to assess safety of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.
Interventions
DEVICEFantom Scaffold
Sponsors
REVA Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ischemia-driven Target Lesion Revascularization (TLR) | 4 months | Percent of Patients with TLR at 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intravascular Ultrasound (IVUS) derived parameters | 4 months | Late Loss |
| Target Vessel Revascularization | 12, 24, 36, 48 and 60 months | Percentage of patients with TVR at each time point |
| 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 |
| Quantitative Coronary Angiography (QCA) derived parameters | 4 months | Late Loss |
| Target Lesion Revascularization (TLR) | 12, 24, 36, 48 and 60 months | Percentage of patients with TLR 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 |
| 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 |
Countries
Brazil, Poland
Outcome results
None listed