The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
272
Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease
The Prince Charles Hospital
Chermside, Australia
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)
Time frame: 6 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
Late Lumen Loss
Time frame: 6 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Late Lumen Loss
Time frame: 9 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
Minimum Lumen Diameter (MLD)
Time frame: 6 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Minimum Lumen Diameter (MLD)
Time frame: 9 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
% Diameter Stenosis
Time frame: 6 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
% Diameter Stenosis
Time frame: 9 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
Binary Restenosis
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
St Vincent's Hospital Sydney
Darlinghurst, Australia
Prince of Wales Hospital (Eastern Heart)
Randwick, Australia
Cardiovascular Center Aalst
Aalst, Belgium
Albert Einstein Hospital
São Paulo, Brazil
Instituto Dante Pazzanese de Cardiologia
São Paulo, Brazil
Aarhus University Hospital (Skejby)
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
institut Hospitalier J.Cartier
Massy, France
...and 18 more locations
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
Binary Restenosis
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12, 24, 36, 48 and 60 months
Acute Technical Success - Cohorts A, B and C
Successful acute delivery and deployment of the device
Time frame: Day 0
Procedural Success - Cohorts A, B and C
Percentage of patients with angiographic success (final diameter stenosis \<50% without occurrence of MACE)
Time frame: 30 days