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Coronary Artery DiseaseNCT03587922

FANTOM Post Market Clinical Trial

A study testing Fantom in people with Coronary Artery Disease, run by REVA Medical, Inc. at 10 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Post Market study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold 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
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,500 participants
Where
10 sitesin 3 countries
Study dates
1 May 2018to 1 May 2025
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

  • The patient is at least 18 years of age.
  • The subject must have evidence of myocardial ischemia
  • The patient is an acceptable candidate for PTCA, stenting and emergent CABG.
  • The patient is willing and able to comply with the specified follow-up evaluations.
  • The patient's written informed consent has been obtained.
  • Each lesion to be treated with Fantom must meet all the following baseline criteria:
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  • De novo lesion in a native coronary artery
  • Visually estimated stenosis of > or equal to 50% and <100%.
  • Visually estimated RVD > or equal to 2.5 mm and less than or equal to 3.75 mm.
  • Baseline TIMI flow greater than or equal to 2 per visual estimate.
  • Lesion Length less than or equal to 20 mm, able to be covered by a single scaffold
  • No angiographic complications (e.g. distal embolization, side branch closure).
  • No dissections greater than or equal to NHLBI type C.
  • Patient has no ongoing chest pain or ECG ST-segment of T-wave changes.

Who cannot join

  • The patient has a known allergy, intolerance, or is contraindicated to aspirin, both heparin and bivalirudin, clopidogrel and/or contrast media, and cannot be adequately pre-medicated.
  • The patient has experienced an acute ST-segment elevation myocardial infarction (AMI: STEMI) within 72 hours of the procedure and either CK-MB or Troponin has not returned to within ULN (Note: the patient with a recent NSTEMI with elevated biomarkers may still be enrolled).
  • The patient has a left ventricular ejection fraction of <30%.
  • The patient has unprotected left main coronary disease with greater than or equal to 50% stenosis.
  • The patient has undergone prior PCI within the target vessel during the last 12 months.
  • Prior PCI of a non-target vessel within 24 hours prior to the procedure, or within 30 days prior to the procedure if unsuccessful or complicated. Note: Prior PCI of a non-target vessel is acceptable if performed anytime > 30 days before the index procedure or between a minimum of 24 hours and 30 days before the index procedure is successful and uncomplicated.
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  • Prior PCI within 3 years with a bioresorbable scaffold in any vessel.
  • The patient requires future staged PCI of any lesion other than a target lesion identified at the time of the index procedure.
  • The patient has received any solid organ transplant or is on a waiting list for any solid organ transplant.
  • At the time of screening, the subject has a malignancy that is not in remission.
  • The patient is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy.
  • The patient has a stent located within 3 mm of the target lesion borders.
  • The target vessel is totally occluded (TIMI Flow 0 to 1).
  • Excessive proximal tortuosity, vessel hinging at the lesion location or lesion angulation, such that in the operator's judgment it is unlikely that the Fantom Bioresorbable Coronary Scaffold or a standard scaffold could be delivered and/or expanded.
  • The patient is currently participating in another investigational drug or device trial that has not reached its primary endpoint assessment
  • The patient has co-morbidities which reduce life expectancy to less than or equal to 24 months, or a condition that may interfere with the follow-up procedures of this protocol.
  • The patient has:
  • Known hepatic impairment (liver function tests (SGOT, SGPT, or ALT) >3 times normal);
  • Known impaired renal function (serum creatinine greater than or equal to 2.5 mg/dL).
  • A platelet count <100,000 cells/mm3 and/or >700,000 cells/mm3
  • The patient has a history of stroke (CVA) or TIA within the prior 6 months, or any permanent neurologic defect, or any prior history of intracerebral bleeding.
  • The patient has an active peptic ulcer or upper GI bleeding within the prior 6 months.
  • The patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
  • The patient is a woman that is pregnant or lactating or is planning to get pregnant during the follow-up period of this trial. Note: Women of child-bearing potential should have a negative pregnancy test before enrollment.
  • Target lesion ostial (within 3mm of vessel origin).
  • Target lesion is located in the left main or there is a > 30% diameter stenosis in the left main artery
  • Target lesion has moderate to severe calcification.
  • Target segment(s) has one or more side branches >2.0 mm in diameter.
  • Target segment(s) has a side branch with either an ostial or non-ostial lesion with diameter stenosis >50% or requiring dilation
  • Target lesion is located within an arterial bypass graft conduit or saphenous vein graft.
  • Target lesion is located within a previously stented region.
  • Target lesion is located within a segment supplied by distal graft.
  • Target lesion has possible or definite thrombus.
  • The patient is currently receiving or will require chronic anticoagulation therapy (e.g. coumadin, dabigatran, apixaban, rivaroxaban, or edoxaban for any reason).
  • The patient is known to need or has a planned surgical procedure or any other reason is present which might require discontinuing aspirin and/or clopidogrel within 1 year of the Fantom scaffold implantation
  • Patient has a known allergy to tyrosine derived polycarbonate or Sirolimus and its structurally related compounds.

Trial locations and contacts

10 sites in 3 countries.

Jeffrey Anderson contact

8589663038

janderson@revamedical.com

10 sites in 3 countries

Germany8 sites, 8 recruiting

  • Juedisches Krankenhaus Berlin

    Berlin

    Kristof Graf, Prof.Dr.med.

    Recruiting

  • Technische Universitat Dresden

    Dresden

    Axel Linke, Prof.Dr.

    Recruiting

  • Universitatsklinikum Halle

    Halle

    Michel Noutsias, PD Dr. med.

    Recruiting

  • Klinikum Herford

    Herford

    Krzysztof Pujdak, Dr. med.

    Recruiting

  • Universitatsklinikum Schleswig-Holstein, Campus Kiel

    Kiel

    Matthias Lutz, MD, Matthias.Lutz@uksh.de

    Recruiting

  • Clemenshospital Muenster

    Münster

    Olaf Oldenburg, Dr.

    Recruiting

  • Klinkum Oldenburg

    Oldenburg

    Albrecht Elsasser, Prof.Dr.med.

    Recruiting

  • Marien Hospital Witten

    Witten

    Hans-Jorg Hippe, Dr.med.

    Recruiting

Other trials in Germany

Austria1 site, 1 recruiting

  • Wilhelminenhospital

    Vienna

    Kurt Huber, Prof.Dr.

    Recruiting

Other trials in Austria

Switzerland1 site, 1 recruiting

  • University Kantonsspital Baselland

    Liestal

    Gregor Leibundgut, PD. Dr.

    Recruiting

Other trials in Switzerland

About this study

Official title: Post Market Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold

Post Market study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold

Being tested
Fantom
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.

  • FantomDevice

    Treatment of den ovo coronary lesions

Study groups in NCT03587922
Study groupRoleWhat they receive
Treatment ArmExperimentalSingle arm study with treatment of Fantom scaffold
Receives: Device: Fantom

What is being measured

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

  1. Target Lesion Failure

    TLF Composite defined by rate of Cardiac Death, Target Vessel MI and Ischemic Driven Target Lesion Revascularization

    Measured: 12 Months

Timeline

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

  1. First posted16 Jul 2018
  2. Study start1 May 2018
  3. Primary completion1 May 2025 (estimated)
  4. Study completion1 May 2025 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03587922
Sponsor's protocol ID
HCT6700
Status last verified
Jun 2024
First submitted
3 Jul 2018
Last updated
14 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Fantom in people with Coronary Artery Disease, run by REVA Medical, Inc. at 10 sites in 3 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 14 inclusion and 36 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: status not confirmed, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Germany, Austria, Switzerland. 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?

Results are not available in the source record.

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

Contact Jeffrey Anderson (8589663038, janderson@revamedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Lesion Failure (time frame: 12 Months). 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 NCT03587922.

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 14 Jun 2024.

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FANTOM Post Market Clinical Trial (NCT03587922) | AzTrials