Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
FANTOM II
1 other identifier
interventional
272
8 countries
28
Brief Summary
The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable coronary-artery-disease
Started Mar 2015
Longer than P75 for not_applicable coronary-artery-disease
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 1, 2015
CompletedFirst Posted
Study publicly available on registry
September 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2024
CompletedApril 4, 2025
April 1, 2025
4.4 years
September 1, 2015
April 1, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (13)
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
9 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
6 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
9 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C
6 months
Quantitative Coronary Angiography (QCA) derived parameters - Cohort B
9 months
- +8 more secondary outcomes
Study Arms (3)
Cohort A
EXPERIMENTALFantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group A (6-month angiographic follow-up)
Cohort B
EXPERIMENTALFantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group B (9-month angiographic follow-up)
Cohort C
EXPERIMENTALFantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group C (6-month angiographic follow-up), Long Lesion/Multi-Vessel
Interventions
Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
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
Related Publications (1)
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.
PMID: 31177821DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandre Abizaid, MD, PhD
Instituto Dante Pazzanese de Cardiologia
- PRINCIPAL INVESTIGATOR
Christoph K Naber, PD Dr. med
Elisabeth-Krankenhaus Essen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2015
First Posted
September 3, 2015
Study Start
March 1, 2015
Primary Completion
August 1, 2019
Study Completion
September 1, 2024
Last Updated
April 4, 2025
Record last verified: 2025-04