MedJ-01 Ridaforolimus Eluting Coronary Stent System Trial (JNIR)
Japan104 participantsStarted 2017-01-16
Plain-language summary
MedJ-01 Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising:
* A mounted Cobalt Chromium (CoCr) alloy based stent
* A Rapid Exchange (RX) Coronary System Delivery System
* A Poly n-butyl methacrylate (PBMA) and CarboSil®Polymer matrix coating
* Ridaforolimus drug - CAS Registry Number: 572924-54-0 MedJ-01 is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to lesions in vessels with reference diameters of 2.5 mm to 4.25 mm, including complex lesions.
JNIR01 is aimed at assessing TLF at one year with the MedJ-01 stent in a Japanese patient population to show equivalence to the results of the BIONICS Trial.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Patient with indication for PCI including angina (stable/unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), NSTEMI, or recent subacute STEMI. For subacute STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be \>72 hours prior to enrollment and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked.
✓. Non-target vessel PCI are allowed prior to enrollment depending on the time interval and conditions as follows:
Exclusion criteria
✕. Patient is willing and able to provide informed written consent and comply with follow-up visits and testing schedule.
✕. Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm.
✕. Complex lesions are allowed including calcified lesions (lesion preparation with scoring/cutting and rotational atherectomy are allowed), presence of thrombus that is non-occlusive and does not require thrombectomy, CTO, bifurcationlesions (except planned dual stent implantation), ostial RCA lesions, tortuous lesions, bare metal stent restenotic lesions, protected left main lesions.
. Overlapping stents are allowed with the investigational device (MedJ-01).
✕. STEMI within 72 hours (subacute) of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin) have not peaked.
✕. PCI within the 24 hours preceding the baseline procedure.
✕. Non-target lesion PCI in the target vessel within 12 months of the baseline procedure.