Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
NCT ID: NCT02539966
Last Updated: 2025-04-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
272 participants
INTERVENTIONAL
2015-03-31
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohort A
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group A (6-month angiographic follow-up)
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease
Cohort B
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group B (9-month angiographic follow-up)
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease
Cohort C
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group C (6-month angiographic follow-up), Long Lesion/Multi-Vessel
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease
Interventions
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Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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REVA Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Alexandre Abizaid, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Dante Pazzanese de Cardiologia
Christoph K Naber, PD Dr. med
Role: PRINCIPAL_INVESTIGATOR
Elisabeth-Krankenhaus Essen
Locations
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The Prince Charles Hospital
Chermside, , Australia
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
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
Countries
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References
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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.
Other Identifiers
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HCT6200
Identifier Type: -
Identifier Source: org_study_id
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