- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03587922
FANTOM Post Market Clinical Trial
March 27, 2023 updated by: REVA Medical, Inc.
Post Market Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
Post Market study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
1500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jeffrey Anderson
- Phone Number: 8589663038
- Email: janderson@revamedical.com
Study Locations
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Wien, Austria
- Recruiting
- Wilhelminenhospital
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Contact:
- Kurt Huber, Prof.Dr.
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Berlin, Germany
- Recruiting
- Juedisches Krankenhaus Berlin
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Contact:
- Kristof Graf, Prof.Dr.med.
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Dresden, Germany
- Recruiting
- Technische Universitat Dresden
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Contact:
- Axel Linke, Prof.Dr.
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Halle, Germany
- Recruiting
- Universitätsklinikum Halle
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Contact:
- Michel Noutsias, PD Dr. med.
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Herford, Germany
- Recruiting
- Klinikum Herford
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Contact:
- Krzysztof Pujdak, Dr. med.
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Kiel, Germany
- Recruiting
- Universitätsklinikum Schleswig-Holstein, Campus Kiel
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Münster, Germany
- Recruiting
- Clemenshospital Muenster
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Contact:
- Olaf Oldenburg, Dr.
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Oldenburg, Germany
- Recruiting
- Klinkum Oldenburg
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Contact:
- Albrecht Elsasser, Prof.Dr.med.
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Witten, Germany
- Recruiting
- Marien Hospital Witten
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Contact:
- Hans-Jorg Hippe, Dr.med.
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Liestal, Switzerland
- Recruiting
- University Kantonsspital Baselland
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Contact:
- Gregor Leibundgut, PD. Dr.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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:
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Treatment Arm
Single arm study with treatment of Fantom scaffold
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Treatment of den ovo coronary lesions
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Target Lesion Failure
Time Frame: 12 Months
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TLF Composite defined by rate of Cardiac Death, Target Vessel MI and Ischemic Driven Target Lesion Revascularization
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12 Months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2018
Primary Completion (Anticipated)
May 1, 2025
Study Completion (Anticipated)
May 1, 2025
Study Registration Dates
First Submitted
July 3, 2018
First Submitted That Met QC Criteria
July 3, 2018
First Posted (Actual)
July 16, 2018
Study Record Updates
Last Update Posted (Actual)
March 29, 2023
Last Update Submitted That Met QC Criteria
March 27, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HCT6700
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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