MedJ-01 リダフォロリムス溶出冠動脈ステントシステム試験（JNIR）

基本情報

NCT ID

NCT02828917

ステータス

完了

試験のフェーズ

該当なし

試験タイプ

介入

目標被験者数

104

治験依頼者名

Medinol Ltd.

概要

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.

対象疾患

介入

依頼者（Sponsor）

実施施設 (1)