Safety & Performance Study of the FANTOM Sirolimus-Eluting Bioresorbable Coronary Scaffold
- Conditions
- Insufficient blood flowtissue of the heart muscle10011082
- Registration Number
- NL-OMON55419
- Lead Sponsor
- REVA Medical, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 19
* The patient is * 18 years of age
* The subject must have evidence of myocardial ischemia (e.g. stable, unstable
angina, post-infarct angina or silent ischemia) suitable for elective PCI.
Subjects with stable angina or silent ischemia and < 70% diameter stenosis must
have objective signs of ischemia as determined by one of the following:
echocardiogram, nuclear scans, ambulatory ECG or stress ECG. In the absence of
noninvasive ischemia, FFR must be done and must be indicative of 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 prior to the
procedure
* Each lesion must meet all the following baseline criteria (prior to
pre-dilation):
- De novo lesion in a native coronary artery
- Visually estimated stenosis of * 50% and <100%
- Visually estimated RVD * 2.5 mm and * 3.5 mm
- Lesion length * 20 mm by visual estimate
- Baseline TIMI flow * 2 per visual estimate
* During pre-dilatation the pre-dilatation balloon is uniformly expanded to the
full intended diameter
* Immediately after the pre-dilatation process the patient does not experience
chest pain or ECG changes lasting longer than 10 minutes
* Each lesion must meet all the following criteria after pre-dilatation:
- Visually estimated stenosis of * 40%
- Target vessel reference diameter * 2.5 mm and * 3.5 mm by QCA, IVUS or OCT
- Lesion length * 20 mm by visual estimate
- Post pre-dilatation TIMI flow * 3 per visual estimate
- No dissections * type C
* 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 myocardial infarction (AMI: STEMI or
NSTEMI) within 72 hours of the procedure and either CK-MB or Troponin has not
returned to within 2X ULN. Note: In the event that CK-MB is not measured prior
to treatment, the patient will be considered to have met this enrollment
criteria provided that the Troponin assessment is within 2X ULN and a blood
sample is drawn prior to the procedure; the CK-MB analysis must then be
performed post-procedure
* The patient is currently experiencing clinical symptoms consistent with AMI
* The patient has a left ventricular ejection fraction of <40%
* The patient requires or has had an additional intervention of a coronary
lesion in the target vessel within 1 year of the index procedure
* The patient requires additional intervention of another coronary lesion in
the target epicardial vessel (LAD, LCX or RCA) or branch of the target
epicardial vessel during the index procedure
Note: Staged procedures to treat lesions in non-target epicardial vessels are
allowed during the index procedure or > 30 days after REVA scaffold
implantation. If a non-target lesion requires treatment during the index
procedure, the non-target lesion should be treated first
* The patient has unprotected left main coronary disease with * 50% stenosis
* The patient has a significant (* 50%) untreated stenosis proximal or distal
to the target lesion
* The patient has a scaffold(s) or 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
REVA 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 completed the entire follow-up period
* The patient has a co-morbidity, which reduces life expectancy to * 24 months,
or factors making clinical follow-up difficult
* The patient has:
- Known hepatic impairment (Liver function tests (SGOT, SGPT, and ALT) >3 times
normal)
- Known impaired renal function (serum creatinine * 2.5 mg/dL)
- A platelet count <100,000 cells/mm3 (thrombocytopenia); and/or >700,000
cells/mm3
* The patient has a history of stroke (CVA) or TIA within the prior 6 months
* 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
* Target lesion ostial (within 3mm of vessel origin)
* Target lesion has moderate to severe calcification
* Target segment has side branches or a bifurcation > 1.5 mm in diameter
* 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 currentl
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Major Adverse Cardiac Events (MACE) and Late Lumen Loss at 6 months.</p><br>
- Secondary Outcome Measures
Name Time Method