Coronary Artery Disease
Conditions
Brief summary
The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.
Interventions
DEVICEFantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease
Sponsors
REVA Medical, Inc.
Study design
Allocation
NON_RANDOMIZED
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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 Revascularization (TVR) - Cohorts A, B and C | 12, 24, 36, 48 and 60 months | Percentage of patients with TVR at each time point |
| Quantitative Coronary Angiography (QCA) derived parameters - Cohort B | 9 months | Late Lumen Loss |
| Acute Technical Success - Cohorts A, B and C | Day 0 | Successful acute delivery and deployment of the device |
| Procedural Success - Cohorts A, B and C | 30 days | Percentage of patients with angiographic success (final diameter stenosis \<50% without occurrence of MACE) |
| 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 |
| Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C | 6 months | Minimum Lumen Diameter (MLD) |
Countries
Australia, Belgium, Brazil, Denmark, France, Germany, Netherlands, Poland
Outcome results
None listed