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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A | Experimental | Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group A (6-month angiographic follow-up) |
|
| Cohort B | Experimental | Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group B (9-month angiographic follow-up) |
|
| Cohort C | Experimental | Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group C (6-month angiographic follow-up), Long Lesion/Multi-Vessel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold | Device | Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Abizaid, MD, PhD | Instituto Dante Pazzanese de Cardiologia | Principal Investigator |
| Christoph K Naber, PD Dr. med | Elisabeth-Krankenhaus Essen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Prince Charles Hospital | Chermside | Australia | ||||
| St Vincent's Hospital Sydney |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31177821 | Derived | Chevalier B, Abizaid A, Carrie D, Frey N, Lutz M, Weber-Albers J, Dudek D, Weng SC, Akodad M, Anderson J, Stone GW. Clinical and Angiographic Outcomes With a Novel Radiopaque Sirolimus-Eluting Bioresorbable Vascular Scaffold. Circ Cardiovasc Interv. 2019 Jun;12(6):e007283. doi: 10.1161/CIRCINTERVENTIONS.118.007283. Epub 2019 Jun 10. |
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| 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 |
| 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 |
| La Pitié-Salpétrière | Paris | France |
| Clinique Pasteur | Toulouse | France |
| Hôpital Rangueil | Toulouse | France |
| Am Urban Hospital, Berlin | Berlin | Germany |
| Friedrichshein Hospital, Berlin | Berlin | Germany |
| Klinikum Coburg | Coburg | Germany |
| St.- Johannes-Hospital Dortmund | Dortmund | Germany |
| Universitätsklinikum Erlangen | Erlangen | Germany |
| Elisabeth-Krankenhaus Essen | Essen | Germany |
| Universitätsklinikum Schleswig-Holstein | Kiel | Germany |
| Academic Medical Center Amsterdam | Amsterdam | Netherlands |
| Onze Lieve Vrouwe Gasthuis | Amsterdam | Netherlands |
| Erasmus Medical Center | Rotterdam | Netherlands |
| University Medical Center Utrecht | Utrecht | Netherlands |
| Krakowskie Centrum Kardiologii Inwazyjnej | Krakow | Poland |
| Szpital Uniwersytecki w Krakowie | Krakow | Poland |
| Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu | Poznan | Poland |
| Oddział Kardiologii Inwazyjnej I Katedra | Warsaw | Poland |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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