Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold

Study Overview
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Brief Summary
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The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.

Official Title
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Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: Fantom Sirolimus-Eluting Coronary Bioresorbable 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 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

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A<br>Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group A (6-month angiographic follow-up) | Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold<br>* Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease<br>|
| Experimental: Cohort B<br>Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group B (9-month angiographic follow-up) | Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold<br>* Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease<br>|
| Experimental: Cohort C<br>Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group C (6-month angiographic follow-up), Long Lesion/Multi-Vessel | Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold<br>* Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events (MACE) - Cohorts A, B and C | Cardiac Death, Myocardial Infarction (Q-Wave, Non Q-wave: CK-MB >5X ULN) (MI), and target lesion revascularization (TLR) | 6 months | 
| Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C | Late Lumen Loss | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative Coronary Angiography (QCA) derived parameters - Cohort B | Late Lumen Loss | 9 months | 
| Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C | Minimum Lumen Diameter (MLD) | 6 months | 
| Quantitative Coronary Angiography (QCA) derived parameters - Cohort B | Minimum Lumen Diameter (MLD) | 9 months | 
| Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C | % Diameter Stenosis | 6 months | 
| Quantitative Coronary Angiography (QCA) derived parameters - Cohort B | % Diameter Stenosis | 9 months | 
| Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C | Binary Restenosis | 6 months | 
| Quantitative Coronary Angiography (QCA) derived parameters - Cohort B | Binary Restenosis | 9 months | 
| Major Adverse Cardiac Events (MACE) - Cohorts A, B and C | Cardiac Death, Myocardial Infarction (Q-Wave, Non Q-wave: CK-MB >5X ULN) (MI), and target lesion revascularization (TLR) | 12, 24, 36, 48 and 60 months | 
| Target Lesion Revascularization (TLR) - Cohorts A, B and C | Percentage of patients with TLR at each time point | 12, 24, 36, 48 and 60 months | 
| Target Vessel Revascularization (TVR) - Cohorts A, B and C | Percentage of patients with TVR at each time point | 12, 24, 36, 48 and 60 months | 
| Target Vessel Failure (TVF) - Cohorts A, B and C | Percentage of patients with TVF at each time point | 12, 24, 36, 48 and 60 months | 
| Acute Technical Success - Cohorts A, B and C | Successful acute delivery and deployment of the device | Day 0 | 
| Procedural Success - Cohorts A, B and C | Percentage of patients with angiographic success (final diameter stenosis <50% without occurrence of MACE) | 30 days |