Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
- Registration Number
- NCT02539966
- Lead Sponsor
- REVA Medical, Inc.
- Brief Summary
The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 272
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort C Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group C (6-month angiographic follow-up), Long Lesion/Multi-Vessel Cohort A Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group A (6-month angiographic follow-up) Cohort B Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group B (9-month angiographic follow-up)
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Quantitative Coronary Angiography (QCA) derived parameters - Cohort B 9 months Binary Restenosis
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 Failure (TVF) - Cohorts A, B and C 12, 24, 36, 48 and 60 months Percentage of patients with TVF at each time point
Acute Technical Success - Cohorts A, B and C Day 0 Successful acute delivery and deployment of the device
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C 6 months Binary Restenosis
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 Vessel Revascularization (TVR) - Cohorts A, B and C 12, 24, 36, 48 and 60 months Percentage of patients with TVR at each time point
Procedural Success - Cohorts A, B and C 30 days Percentage of patients with angiographic success (final diameter stenosis \<50% without occurrence of MACE)
Trial Locations
- Locations (28)
The Prince Charles Hospital
🇦🇺Chermside, Australia
St Vincent's Hospital Sydney
🇦🇺Darlinghurst, Australia
Prince of Wales Hospital (Eastern Heart)
🇦🇺Randwick, Australia
Albert Einstein Hospital
🇧🇷São Paulo, Brazil
Instituto Dante Pazzanese de Cardiologia
🇧🇷Sao Paulo, Brazil
institut Hospitalier J.Cartier
🇫🇷Massy, France
La Pitié-Salpétrière
🇫🇷Paris, France
Clinique Pasteur
🇫🇷Toulouse, France
Am Urban Hospital, Berlin
🇩🇪Berlin, Germany
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Elisabeth-Krankenhaus Essen
🇩🇪Essen, Germany
Erasmus Medical Center
🇳🇱Rotterdam, Netherlands
Szpital Uniwersytecki w Krakowie
🇵🇱Krakow, Poland
Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu
🇵🇱Poznan, Poland
Oddział Kardiologii Inwazyjnej I Katedra
🇵🇱Warszawa, Poland
Universitätsklinikum Schleswig-Holstein
🇩🇪Kiel, Germany
Cardiovascular Center Aalst
🇧🇪Aalst, Belgium
Krakowskie Centrum Kardiologii Inwazyjnej
🇵🇱Krakow, Poland
Aarhus University Hospital (Skejby)
🇩🇰Aarhus, Denmark
Odense University Hospital
🇩🇰Odense, Denmark
Hôpital Rangueil
🇫🇷Toulouse, France
Friedrichshein Hospital, Berlin
🇩🇪Berlin, Germany
Klinikum Coburg
🇩🇪Coburg, Germany
St.- Johannes-Hospital Dortmund
🇩🇪Dortmund, Germany
Academic Medical Center Amsterdam
🇳🇱Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
Rigshospitalet
🇩🇰Copenhagen, Denmark
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands