Multi-center Study for Evaluating the Safety and Efficacy of the MedJ-01 Ridaforolimus Eluting Coronary Stent System (MedJ-01) In Coronary Stenosis Trial

Medinol Ltd.1 个研究点分布在 1 个国家目标入组 104 人2017年1月16日

适应症de Novo or Restenosis Lesions

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: de Novo or Restenosis Lesions
发起方: Medinol Ltd.
入组人数: 104
试验地点: 1
主要终点: Target Lesion Failure (TLF)
状态: 已完成
最后更新: 2年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

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.

详细描述

This study aims to evaluate MedJ-01 safety and efficacy for de novo or restenosis lesion with target vessel diameter of 2.5mm to 4.25, for subjects undergoing coronary artery stent implantation. The target population is subjects undergoing PCI for angina (stable or 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, and recent subacute STEMI (\>72 hours from initial presentation and stable). Complex lesions are allowed. A maximum of two target vessels and two lesions per vessel may be treated (two lesions separated by up to 10 mm that can be covered by a single stent are considered as one lesion); the total planned study stenting in the coronary tree cannot exceed 100 mm.

注册库

clinicaltrials.gov

开始日期

2017年1月16日

结束日期

2022年8月30日

最后更新

2年前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Medinol Ltd.

责任方

Sponsor

入排标准

入选标准

•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:
•During Baseline Procedure:
•PCI of non-target vessels performed during the baseline procedure itself immediately prior to enrollment if successful and uncomplicated defined as: \<50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding.
•Less than 24 hours prior to Baseline Procedure:
•Not allowed (see exclusion criterion #2).
•24 hours-30 days prior to Baseline Procedure:
•PCI of non-target vessels 24 hours to 30 days prior to enrollment if successful and uncomplicated as defined above.
•In addition, in cases where non-target vessel PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI.
•If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling.

排除标准

•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.
•History of stent thrombosis.
•Cardiogenic shock (defined as persistent hypotension (systolic blood pressure \<90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP.
•Subject is intubated.
•Known LVEF \<30%.
•Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed)
•Subject has an indication for chronic oral anticoagulant treatment (with either vitamin K antagonists or novel anticoagulants - NOACs)
•Calculated creatinine clearance \<30 mL/min using Cockcroft-Gault equation.

结局指标

主要结局

Target Lesion Failure (TLF)

时间窗: 12 months

TLF is defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization.

次要结局

Procedure Success at Time of Baseline Procedure(30 days, 6 months, and 1, 2, 3, 4 and 5 years)
TLF(30 days, 6 months, and 2, 3, 4 and 5 years)
Major Adverse Cardiac Events (MACE)(30 days, 6 months, and 1, 2, 3, 4 and 5 years)
Device Success at Time of Baseline Procedure(30 days, 6 months, and 1, 2, 3, 4 and 5 years)
Myocardial Infarction(30 days, 6 months, and 1, 2, 3, 4 and 5 years)
Target Vessel Related MI(30 days, 6 months, and 1, 2, 3, 4 and 5 years)
Ischemia-driven TLR(30 days, 6 months, and 1, 2, 3, 4 and 5 years)
Stent Thrombosis(30 days, 6 months, and 1, 2, 3, 4 and 5 years)
All-cause Mortality(30 days, 6 months, and 1, 2, 3, 4 and 5 years)
Ischemia-driven TVR(30 days, 6 months, and 1, 2, 3, 4 and 5 years)
Lesion Success at Time of Baseline Procedure(30 days, 6 months, and 1, 2, 3, 4 and 5 years)
Target Vessel Failure (TVF)(30 days, 6 months, and 1, 2, 3, 4 and 5 years)
Cardiac Death(30 days, 6 months, and 1, 2, 3, 4 and 5 years)