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Coronary Artery DiseaseFANTOM IINCT02539966

Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold

A study testing Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold in people with Coronary Artery Disease, run by REVA Medical, Inc. at 28 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
272 participants
Where
28 sitesin 8 countries
Study dates
Mar 2015to Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

28 sites in 8 countries.

28 sites in 8 countries

Germany7 sites

  • Am Urban Hospital, Berlin

    Berlin

  • Friedrichshein Hospital, Berlin

    Berlin

  • Klinikum Coburg

    Coburg

  • St.- Johannes-Hospital Dortmund

    Dortmund

  • Universitätsklinikum Erlangen

    Erlangen

  • Elisabeth-Krankenhaus Essen

    Essen

  • Universitätsklinikum Schleswig-Holstein

    Kiel

Other trials in Germany

France4 sites

  • institut Hospitalier J.Cartier

    Massy

  • La Pitié-Salpétrière

    Paris

  • Clinique Pasteur

    Toulouse

  • Hôpital Rangueil

    Toulouse

Other trials in France

Netherlands4 sites

  • Academic Medical Center Amsterdam

    Amsterdam

  • Onze Lieve Vrouwe Gasthuis

    Amsterdam

  • Erasmus Medical Center

    Rotterdam

  • University Medical Center Utrecht

    Utrecht

Other trials in Netherlands

Poland4 sites

  • Krakowskie Centrum Kardiologii Inwazyjnej

    Krakow

  • Szpital Uniwersytecki w Krakowie

    Krakow

  • Szpital Kliniczny Przemienienia Panskiego UM w Poznaniu

    Poznan

  • Oddział Kardiologii Inwazyjnej I Katedra

    Warsaw

Other trials in Poland

Australia3 sites

  • The Prince Charles Hospital

    Chermside

  • St Vincent's Hospital Sydney

    Darlinghurst

  • Prince of Wales Hospital (Eastern Heart)

    Randwick

Other trials in Australia

Denmark3 sites

  • Aarhus University Hospital (Skejby)

    Aarhus

  • Rigshospitalet

    Copenhagen

  • Odense University Hospital

    Odense

Other trials in Denmark

Brazil2 sites

  • Albert Einstein Hospital

    São Paulo

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo

Other trials in Brazil

Belgium1 site

  • Cardiovascular Center Aalst

    Aalst

Other trials in Belgium

About this study

The FANTOM II trial is intended to assess safety and performance of the Fantom Bioresorbable Coronary Scaffold in native coronary arteries.

Being tested
Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fantom Sirolimus-Eluting Coronary Bioresorbable ScaffoldDevice

    Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease

Study groups in NCT02539966
Study groupRoleWhat they receive
Cohort AExperimentalFantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group A (6-month angiographic follow-up)
Receives: Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Cohort BExperimentalFantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group B (9-month angiographic follow-up)
Receives: Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold
Cohort CExperimentalFantom Sirolimus-Eluting Coronary Bioresorbable Scaffold - Treatment Group C (6-month angiographic follow-up), Long Lesion/Multi-Vessel
Receives: Device: Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 6 months

  2. Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C

    Late Lumen Loss

    Measured: 6 months

Secondary outcomes (13)

  1. Quantitative Coronary Angiography (QCA) derived parameters - Cohort B

    Late Lumen Loss

    Measured: 9 months

  2. Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C

    Minimum Lumen Diameter (MLD)

    Measured: 6 months

  3. Quantitative Coronary Angiography (QCA) derived parameters - Cohort B

    Minimum Lumen Diameter (MLD)

    Measured: 9 months

  4. Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C

    % Diameter Stenosis

    Measured: 6 months

  5. Quantitative Coronary Angiography (QCA) derived parameters - Cohort B

    % Diameter Stenosis

    Measured: 9 months

  6. Quantitative Coronary Angiography (QCA) derived parameters - Cohorts A and C

    Binary Restenosis

    Measured: 6 months

  7. Quantitative Coronary Angiography (QCA) derived parameters - Cohort B

    Binary Restenosis

    Measured: 9 months

  8. 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)

    Measured: 12, 24, 36, 48 and 60 months

  9. Target Lesion Revascularization (TLR) - Cohorts A, B and C

    Percentage of patients with TLR at each time point

    Measured: 12, 24, 36, 48 and 60 months

  10. Target Vessel Revascularization (TVR) - Cohorts A, B and C

    Percentage of patients with TVR at each time point

    Measured: 12, 24, 36, 48 and 60 months

  11. Target Vessel Failure (TVF) - Cohorts A, B and C

    Percentage of patients with TVF at each time point

    Measured: 12, 24, 36, 48 and 60 months

  12. Acute Technical Success - Cohorts A, B and C

    Successful acute delivery and deployment of the device

    Measured: Day 0

  13. Procedural Success - Cohorts A, B and C

    Percentage of patients with angiographic success (final diameter stenosis <50% without occurrence of MACE)

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionAug 2019
  4. Study completionSep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02539966
Sponsor's protocol ID
HCT6200
Acronym
FANTOM II
Status last verified
Apr 2025
First submitted
1 Sep 2015
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 31177821

Questions about this trial

What is this clinical trial studying?

A study testing Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold in people with Coronary Artery Disease, run by REVA Medical, Inc. at 28 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in Germany, France, Netherlands, Poland, Australia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Cardiac Events (MACE) - Cohorts A, B and C (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02539966, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

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