FANTOM Post Market Clinical Trial

NCT ID: NCT03587922

Last Updated: 2024-06-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2025-05-01

Brief Summary

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

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment Arm

Single arm study with treatment of Fantom scaffold

Group Type: EXPERIMENTAL

Fantom

Intervention Type: DEVICE

Treatment of den ovo coronary lesions

Interventions

Fantom

Treatment of den ovo coronary lesions

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

REVA Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Wilhelminenhospital

Vienna, , Austria

Site Status: RECRUITING

Juedisches Krankenhaus Berlin

Berlin, , Germany

Site Status: RECRUITING

Technische Universitat Dresden

Dresden, , Germany

Site Status: RECRUITING

Universitatsklinikum Halle

Halle, , Germany

Site Status: RECRUITING

Klinikum Herford

Herford, , Germany

Site Status: RECRUITING

Universitatsklinikum Schleswig-Holstein, Campus Kiel

Kiel, , Germany

Site Status: RECRUITING

Clemenshospital Muenster

Münster, , Germany

Site Status: RECRUITING

Klinkum Oldenburg

Oldenburg, , Germany

Site Status: RECRUITING

Marien Hospital Witten

Witten, , Germany

Site Status: RECRUITING

University Kantonsspital Baselland

Liestal, , Switzerland

Site Status: RECRUITING

Countries

Austria; Germany; Switzerland

Central Contacts

Jeffrey Anderson

Role: CONTACT

janderson@revamedical.com

8589663038

Facility Contacts

Kurt Huber, Prof.Dr.

Role: primary

Kristof Graf, Prof.Dr.med.

Role: primary

Axel Linke, Prof.Dr.

Role: primary

Michel Noutsias, PD Dr. med.

Role: primary

Krzysztof Pujdak, Dr. med.

Role: primary

Matthias Lutz, MD

Role: primary

Matthias.Lutz@uksh.de

Olaf Oldenburg, Dr.

Role: primary

Albrecht Elsasser, Prof.Dr.med.

Role: primary

Hans-Jorg Hippe, Dr.med.

Role: primary

Gregor Leibundgut, PD. Dr.

Role: primary

Other Identifiers

HCT6700

Identifier Type: -

Identifier Source: org_study_id