Actively Recruiting
FANTOM Post Market Clinical Trial
Led by REVA Medical, Inc. · Updated on 2024-06-14
1500
Participants Needed
10
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Post Market study of the Fantom Sirolimus-Eluting Bioresorbable Coronary Scaffold
CONDITIONS
Official Title
FANTOM Post Market Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 be a de novo lesion in a native coronary artery.
- Lesion must have visually estimated stenosis of 50% or greater and less than 100%.
- Visually estimated reference vessel diameter (RVD) must be between 2.5 mm and 3.75 mm.
- Baseline TIMI flow must be greater than or equal to 2.
- Lesion length must be 20 mm or less and able to be covered by a single scaffold.
- No angiographic complications such as distal embolization or side branch closure.
- No dissections greater than or equal to NHLBI type C.
- Patient has no ongoing chest pain or ECG ST-segment or T-wave changes.
You will not qualify if you...
- Allergy, intolerance, or contraindication to aspirin, heparin, bivalirudin, clopidogrel, or contrast media that cannot be pre-medicated.
- Acute ST-segment elevation myocardial infarction (STEMI) within 72 hours of the procedure with CK-MB or Troponin not returned to normal.
- Left ventricular ejection fraction less than 30%.
- Unprotected left main coronary disease with 50% or greater stenosis.
- Prior PCI within the target vessel during the last 12 months.
- Prior PCI of a non-target vessel within 24 hours before the procedure or within 30 days if complicated or unsuccessful.
- Prior PCI within 3 years with a bioresorbable scaffold in any vessel.
- Requires future staged PCI of any lesion other than the target lesion.
- Received or waiting for any solid organ transplant.
- Active malignancy not in remission at screening.
- Receiving immunosuppressant therapy or has severe autoimmune disease requiring chronic immunosuppression.
- Stent located within 3 mm of target lesion borders.
- Target vessel totally occluded (TIMI Flow 0 to 1).
- Excessive vessel tortuosity or lesion angulation making scaffold delivery unlikely.
- Currently participating in another investigational drug or device trial without primary endpoint reached.
- Co-morbidities reducing life expectancy to 24 months or interfering with follow-up.
- Known hepatic impairment with liver function tests over 3 times normal.
- Known impaired renal function with serum creatinine ≥ 2.5 mg/dL.
- Platelet count less than 100,000 or greater than 700,000 cells/mm3.
- History of stroke or TIA within prior 6 months, permanent neurologic defect, or prior intracerebral bleeding.
- Active peptic ulcer or upper GI bleeding within prior 6 months.
- History of bleeding disorders or refusal of blood transfusions.
- Pregnant, lactating, or planning pregnancy during follow-up; women of child-bearing potential must have negative pregnancy test.
- Target lesion ostial (within 3 mm of vessel origin).
- Target lesion in left main artery or with more than 30% stenosis in left main.
- Target lesion with moderate to severe calcification.
- Target segment with side branches greater than 2.0 mm diameter.
- Side branch lesion with diameter stenosis over 50% or requiring dilation.
- Target lesion in arterial bypass graft or saphenous vein graft.
- Target lesion in previously stented region.
- Target lesion in segment supplied by distal graft.
- Target lesion with possible or definite thrombus.
- Receiving or requiring chronic anticoagulation therapy.
- Planned surgery or condition requiring discontinuation of aspirin and/or clopidogrel within 1 year of scaffold implantation.
- Known allergy to tyrosine derived polycarbonate or Sirolimus and related compounds.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 10 locations
1
Wilhelminenhospital
Vienna, Austria
Actively Recruiting
2
Juedisches Krankenhaus Berlin
Berlin, Germany
Actively Recruiting
3
Technische Universitat Dresden
Dresden, Germany
Actively Recruiting
4
Universitatsklinikum Halle
Halle, Germany
Actively Recruiting
5
Klinikum Herford
Herford, Germany
Actively Recruiting
6
Universitatsklinikum Schleswig-Holstein, Campus Kiel
Kiel, Germany
Actively Recruiting
7
Clemenshospital Muenster
Münster, Germany
Actively Recruiting
8
Klinkum Oldenburg
Oldenburg, Germany
Actively Recruiting
9
Marien Hospital Witten
Witten, Germany
Actively Recruiting
10
University Kantonsspital Baselland
Liestal, Switzerland
Actively Recruiting
Research Team
J
Jeffrey Anderson
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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