MedJ-01 Ridaforolimus Eluting Coronary Stent System Trial (JNIR)

NCT02828917 | Completed Results DMC

• 1 other identifier: JNIR01
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

de Novo or Restenosis Lesions

Outcome Measures

Primary Outcomes (1)

• Target Lesion Failure (TLF)

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

  12 months

Secondary Outcomes (13)

• Device Success at Time of Baseline Procedure

  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

• 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

Study Arms (1)

MedJ-01 drug eluting stent

EXPERIMENTAL

MedJ-01 Ridaforolimus eluting coronary stent system

Device: MedJ-01 Ridaforolimus Eluting Coronary Stent System

Interventions

MedJ-01 Ridaforolimus Eluting Coronary Stent System DEVICE

MedJ-01 drug eluting stent

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• Over 30 days prior to Baseline Procedure:
• PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated.
• 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).

You may not qualify if:

• 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.
• Hemoglobin \<10 g/dL.
• Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3.
• White blood cell (WBC) count \<3,000 cells/mm3.
• Clinically significant liver disease.
• Active peptic ulcer or active bleeding from any site.

Sponsors & Collaborators

• Medinol Ltd.: lead

Study Sites (1)

Shonan Kamakura General

Kamakura, Kanagawa, 247-8533, Japan

Location

Results Point of Contact

• Title: Dina Kofler, VP Clinical Affairs
• Organization: Medinol

dinak@medinol.com

+97237679032

Study Officials

• Shigeru Saito, MD

  Shonan Kamakura General Hospital

  PRINCIPAL INVESTIGATOR

• Seiji Yamazaki, MD

  Sapporo Higashi Tokushukai Hospital

  PRINCIPAL INVESTIGATOR

• Atsuo Namiki, MD

  Kanto Rosai Hospital

  PRINCIPAL INVESTIGATOR

• Yoshisato Shibata, MD

  Miyazaki Medical Association Hospital

  PRINCIPAL INVESTIGATOR

• Satoru Otsuji, MD

  Higashi Takarazuka Satoh Hospital

  PRINCIPAL INVESTIGATOR

• Shigeu Nakamura, MD

  Kyoto Katsura Hospital

  PRINCIPAL INVESTIGATOR

• Akihiko Takahashi, MD

  Takahashi Hospital

  PRINCIPAL INVESTIGATOR

• Tomohiro Kawasaki, MD

  Shin Koga Hospital

  PRINCIPAL INVESTIGATOR

• Yasuhiro Makita, MD

  Hospital Hakodate Hokkaido

  PRINCIPAL INVESTIGATOR

• Takeshi Serikawa, MD

  Saiseikai Fukuoka General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2016
• First Posted: July 12, 2016
• Study Start: January 16, 2017
• Primary Completion: June 1, 2018
• Study Completion: August 30, 2022
• Last Updated: October 16, 2023
• Results First Posted: September 24, 2020

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)