Trials Sponsors Conditions Drugs Pricing

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
+8 more secondary outcomes

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 SystemDevice

MedJ-01 drug eluting stent

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age20 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Medinol Ltd.
Industrylead

Study Sites (1)

Shonan Kamakura General

Kamakura, Kanagawa, 247-8533, Japan

Results Point of Contact

Title: Dina Kofler, VP Clinical Affairs
Organization: Medinol

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

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

104 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Results Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (1)

MedJ-01 drug eluting stent

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Results Posted

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (13)

Study Arms (1)

MedJ-01 drug eluting stent

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations