FANTOM Post Market Clinical Trial

NCT03587922 | Recruiting DMC

• 1 other identifier: HCT6700
• Study Type: interventional
• Target: 1,500
• Locations: 3 countries
• Sites: 10

Brief Summary

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

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure

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

  12 Months

Study Arms (1)

Treatment Arm

EXPERIMENTAL

Single arm study with treatment of Fantom scaffold

Device: Fantom

Interventions

Fantom DEVICE

Treatment of den ovo coronary lesions

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• REVA Medical, Inc.: lead

Study Sites (10)

Wilhelminenhospital

Vienna, Austria

RECRUITING

Juedisches Krankenhaus Berlin

Berlin, Germany

RECRUITING

Technische Universitat Dresden

Dresden, Germany

RECRUITING

Universitatsklinikum Halle

Halle, Germany

RECRUITING

Klinikum Herford

Herford, Germany

RECRUITING

Universitatsklinikum Schleswig-Holstein, Campus Kiel

Kiel, Germany

RECRUITING

Clemenshospital Muenster

Münster, Germany

RECRUITING

Klinkum Oldenburg

Oldenburg, Germany

RECRUITING

Marien Hospital Witten

Witten, Germany

RECRUITING

University Kantonsspital Baselland

Liestal, Switzerland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Jeffrey Anderson

CONTACT

8589663038; janderson@revamedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: July 16, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (8); AU (1); CH (1)