Pilot Study of the Fantom Bioresorbable Scaffold (FANTOM I)

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

Official Title
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Pilot Study of the REVA Sirolimus-Eluting Bioresorbable Coronary Scaffold

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Fantom Scaffold


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fantom Treatment group<br> | Device: Fantom Scaffold<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemia-driven Target Lesion Revascularization (TLR) | Percent of Patients with TLR at 4 months | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative Coronary Angiography (QCA) derived parameters | Late Loss | 4 months | 
| Quantitative Coronary Angiography (QCA) derived parameters | Restenosis Rate | 4 months | 
| Quantitative Coronary Angiography (QCA) derived parameters | % Diameter Stenosis | 4 months | 
| Quantitative Coronary Angiography (QCA) derived parameters | Minimum Lumen Diameter | 4 months | 
| Quantitative Coronary Angiography (QCA) derived parameters | Neointimal Volume | 4 months | 
| Intravascular Ultrasound (IVUS) derived parameters | Late Loss | 4 months | 
| Intravascular Ultrasound (IVUS) derived parameters | Restenosis Rate | 4 months | 
| Intravascular Ultrasound (IVUS) derived parameters | % Diameter Stenosis | 4 months | 
| Intravascular Ultrasound (IVUS) derived parameters | Minimum Lumen Diameter | 4 months | 
| Intravascular Ultrasound (IVUS) derived parameters | Neointimal Volume | 4 months | 
| Major Adverse Cardiac Events | Death, Q-Wave Myocardial Infarction, Non Q-Wave Myocardial Infarction (CK-MB > 5x normal), Target Vessel Revascularization | 12, 24, 36, 48 and 60 months | 
| Target Lesion Revascularization (TLR) | Percentage of patients with TLR at each time point | 12, 24, 36, 48 and 60 months | 
| Target Vessel Revascularization | Percentage of patients with TVR at each time point | 12, 24, 36, 48 and 60 months | 
| Target Vessel Failure (TVF) | Percentage of patients with TVF at each time point | 12, 24, 36, 48 and 60 months | 
| Acute Technical Success | Percentage of patients with successful acute delivery and deployment of the device | Day 0 | 
| Procedural Success | Percentage of patients with angiographic success (final diameter stenosis <50% without occurrence of MACE) | 30 days | 
| Optical Coherence Tomography (OCT) Imaging on a Subset of Patients | Qualitative measures in a subset of patients | 4 months |