de Novo or Restenosis LesionsJNIRNCT02828917
MedJ-01 Ridaforolimus Eluting Coronary Stent System Trial (JNIR)
A study testing MedJ-01 Ridaforolimus Eluting Coronary Stent System in people with de Novo or Restenosis Lesions, run by Medinol Ltd. at 1 site in Japan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- de Novo or Restenosis Lesions
- What is being tested?
- MedJ-01 Ridaforolimus Eluting Coronary Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteJapan
- Study dates
- 16 Jan 2017to 30 Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
- 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.
- Angiographic inclusion criteria (visual estimate):
- 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).
Who cannot join
- 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.
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- 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.
- Bleeding from any site within the prior 8 weeks requiring active medical or surgical attention.
- If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath.
- History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
- Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attributed to CVA.
- Known allergy to the study stent components e.g. cobalt, nickel, chromium, Carbosil®, PBMA, or limus drugs (ridaforolimus, zotarolimus, tacrolimus, sirolimus, everolimus, or similar drugs or any other analogue or derivative or similar compounds).
- Known allergy to protocol-required concomitant medications such as aspirin, or DAPT (Drugs that inhibit P2Y12 such as clopidogrel and prasugrel), or heparin, or iodinated contrast that cannot be adequately pre-medicated.
- Any co-morbid condition that may cause non-compliance with the protocol (e.g. dementia, substance abuse, etc.) or reduced life expectancy to <24 months (e.g. cancer, severe heart failure, severe lung disease).
- Patient is participating in any other investigational drug or device clinical trial that has not reached its primary endpoint, or plans to participate in any clinical trial.
- Women who are pregnant or breastfeeding (women of child-bearing potential, defined as females of childbearing potential if they have not undergone a permanent contraceptive operation or they are not postmenopausal, must have a negative pregnancy test within one week before treatment. Permanent contraceptive operation is defined as: hysterectomy, hysterosalpingectomy, or bilateral oophorectomy. The status of a female should be considered as postmenopausal when she has not had a period for 12 consecutive months without an alternative medical cause).
- Women who intend to become pregnant within 12 months after the baseline procedure (women of child-bearing potential who are sexually active must agree to use a reliable method of contraception from the time of screening through 12 months after the baseline procedure).
- Patient has received an organ transplant or is on a waiting list for an organ transplant.
- Patient is receiving or scheduled to receive chemotherapy within 30 days before or any time after the baseline procedure.
- Patient is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease (e.g., HIV). Corticosteroids are allowed.
- Angiographic Exclusion Criteria (visual estimate):
- Target lesions in more than two (2) major coronary arteries (i.e., two of LAD, LCX, RCA) and their respective branches (the Ramus Intermedius is defined as a branch of the LCX).
- More than two target lesions per target vessel are planned (two lesions separated by less than 10 mm that can be covered by a single stent are considered as one lesion).
- More than 100 mm length of planned study stenting in the entire coronary tree.
- Occlusive thrombus and/or a thrombus requiring thrombectomy in a target vessel.
- Unprotected left main lesions ≥30%, or planned unprotected left main intervention.
- Ostial LAD or LCX lesions (stenting of any diseased segment within 5 mm of the unprotected left main coronary artery).
- Bifurcation lesions with planned dual stent implantation.
- Stenting of lesions due to DES restenosis.
- Another lesion in a target or non-target vessel (including all side branches) is present that requires or has a high probability of requiring PCI within 12 months after the baseline procedure.
- Target lesion exists in bypass graft vessels.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-center Study for Evaluating the Safety and Efficacy of the MedJ-01 Ridaforolimus Eluting Coronary Stent System (MedJ-01) In Coronary Stenosis Trial
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.
Read the detailed description
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.
- Conditions
- de Novo or Restenosis Lesions
- Being tested
- MedJ-01 Ridaforolimus Eluting Coronary Stent System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedJ-01 Ridaforolimus Eluting Coronary Stent SystemDevice
| Study group | Role | What they receive |
|---|---|---|
| MedJ-01 drug eluting stent | Experimental | MedJ-01 Ridaforolimus eluting coronary stent system Receives: Device: MedJ-01 Ridaforolimus Eluting Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Failure (TLF)
TLF is defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization.
Measured: 12 months
Secondary outcomes (13)
Device Success at Time of Baseline Procedure
Device Success at time of baseline procedure- outcome
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Lesion Success at Time of Baseline Procedure
Lesion Success at time of baseline procedure- outcome
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Procedure Success at Time of Baseline Procedure
Procedure Success at time of baseline procedure- outcome
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
TLF
TLF- target lesion failure
Measured: 30 days, 6 months, and 2, 3, 4 and 5 years
Major Adverse Cardiac Events (MACE)
MACE is the composite rate of cardiac death, any MI or ischemia-driven TLR
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Target Vessel Failure (TVF)
the composite rate of death, target vessel related MI or ischemia-driven TVR
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
All-cause Mortality
All-cause mortality outcome
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Cardiac Death
Cardiac Death outcome
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Myocardial Infarction
Myocardial Infarction (MI)
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Target Vessel Related MI
Target Vessel Related MI outcome
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Ischemia-driven TLR
Ischemia-driven TLR outcome
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Ischemia-driven TVR
Ischemia-driven TVR outcome
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Stent Thrombosis
ARC definite and probable
Measured: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start16 Jan 2017
- Primary completionJun 2018
- Study completion30 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for de Novo or Restenosis LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medinol Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shigeru Saito, MD, Principal investigator, Shonan Kamakura General HospitalSeiji Yamazaki, MD, Principal investigator, Sapporo Higashi Tokushukai HospitalAtsuo Namiki, MD, Principal investigator, Kanto Rosai HospitalYoshisato Shibata, MD, Principal investigator, Miyazaki Medical Association HospitalSatoru Otsuji, MD, Principal investigator, Higashi Takarazuka Satoh HospitalShigeu Nakamura, MD, Principal investigator, Kyoto Katsura HospitalAkihiko Takahashi, MD, Principal investigator, Takahashi HospitalTomohiro Kawasaki, MD, Principal investigator, Shin Koga Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828917
- Sponsor's protocol ID
- JNIR01
- Acronym
- JNIR
- Status last verified
- Oct 2023
- First submitted
- 3 Jul 2016
- Last updated
- 16 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center Study for Evaluating the Safety and Efficacy of the MedJ-01 Ridaforolimus Eluting Coronary Stent System (MedJ-01) In Coronary Stenosis Trial
- ClinicalTrials.gov ID
- NCT02828917
- Acronym / sponsor ID
- JNIR / JNIR01
- Conditions
- de Novo or Restenosis Lesions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Medinol Ltd.Industry (pharma, biotech, devices)
- Study start
- 16 Jan 2017 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- 30 Aug 2022 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Posted 24 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MedJ-01 drug eluting stent | Experimental | Device: MedJ-01 Ridaforolimus Eluting Coronary Stent SystemMedJ-01 Ridaforolimus eluting coronary stent system |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- 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.
Key exclusion criteria (39 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MedJ-01 Ridaforolimus Eluting Coronary Stent System | Device | MedJ-01 drug eluting stent |
Primary outcome
Target Lesion Failure (TLF)
Time frame: 12 months
TLF is defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization.
13 secondary outcomes
Device Success at Time of Baseline Procedure
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Lesion Success at Time of Baseline Procedure
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Procedure Success at Time of Baseline Procedure
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
TLF
Time frame: 30 days, 6 months, and 2, 3, 4 and 5 years
Major Adverse Cardiac Events (MACE)
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Target Vessel Failure (TVF)
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
All-cause Mortality
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Cardiac Death
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Myocardial Infarction
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Target Vessel Related MI
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Ischemia-driven TLR
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Ischemia-driven TVR
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Stent Thrombosis
Time frame: 30 days, 6 months, and 1, 2, 3, 4 and 5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shigeru Saito, MD principal investigator
Shonan Kamakura General Hospital
Seiji Yamazaki, MD principal investigator
Sapporo Higashi Tokushukai Hospital
Atsuo Namiki, MD principal investigator
Kanto Rosai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedJ-01 Ridaforolimus Eluting Coronary Stent System in people with de Novo or Restenosis Lesions, run by Medinol Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Failure (TLF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.