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Coronary StenosisNCT03702608

BIONICS 38 mm Trial EluNIR Ridaforolimus Eluting Coronary Stent System (EluNIR) In Coronary Stenosis Trial

A study testing EluNIR Ridaforolimus Eluting Coronary Stent System in people with Coronary Stenosis, run by Medinol Ltd. at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective, multi-center, single-arm, open-label clinical trial. Clinical follow-up will be performed at 30 days. Follow-up by phone will be performed at 6 months, and 1 year after the procedure. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Stenosis
What is being tested?
EluNIR Ridaforolimus Eluting Coronary Stent System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteIsrael
Study dates
14 Nov 2018to 30 Apr 2020
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General Inclusion Criteria:
  • Age ≥ 18 years.
  • Patient with an indication for PCI including 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, or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to enrollment and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked.
  • An attempt (whether successful or not) was made to implant a 38 mm EluNIR stent (Stent was advanced beyond the guiding catheter).
  • Non-target vessel PCI are allowed prior to the screening for eligibility depending on the time interval and conditions as follows:
  • During Baseline Procedure:
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  • PCI of non-target vessels performed during the baseline procedure itself immediately prior to screening for eligibility, 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 criteria #2). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to the baseline procedure if successful and uncomplicated as defined above.
  • In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must have been 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 baseline procedure whether or not successful and uncomplicated.
  • Patient or legal guardian 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 or bypass graft conduit with visually estimated diameter of ≥2.75 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, CTO, bifurcation lesions, ostial RCA lesions, tortuous lesions, bare metal stent restenotic lesions, protected left main lesions, and saphenous vein graft lesions.
  • Overlapping stents are allowed as long as the first stent implanted is the EluNIR 38 mm long stent

Who cannot join

  • General Exclusion Criteria:
  • STEMI within 24 hours 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.
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  • Subject is intubated.
  • Known LVEF <30%.
  • Relative or absolute contraindication to DAPT for 6 months in non-ACS patients and 12 months in ACS patients (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment).
  • eGFR <30 mL/min
  • 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 cobalt, nickel, chromium, molybdenum, 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 (clopidogrel, prasugrel, ticagrelor), or heparin and bivalirudin, 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 or plans to participate in any other investigational drug or device clinical trial that has not reached its primary endpoint.
  • Women who are pregnant or breastfeeding.
  • 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):
  • Unprotected left main lesions ≥30%, or planned left main intervention.
  • Bifurcation lesions with planned dual stent implantation.
  • Stenting of lesions due to DES restenosis.
  • Occlusive thrombus and/or a thrombus requiring thrombectomy in a target vessel
  • 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.

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Medinol LTD

    Tel Aviv

Other trials in Israel

About this study

Official title: Prospective, Multi-center, Single-arm, Open-label Clinical Trial, to Further Assess the Safety and Efficacy of Long (38 mm) Ridaforolimus Eluting Stent - EluNIR

This is a prospective, multi-center, single-arm, open-label clinical trial. Clinical follow-up will be performed at 30 days. Follow-up by phone will be performed at 6 months, and 1 year after the procedure. Study Objective is to further assess the safety and efficacy of long (38 mm) Ridaforolimus Eluting Stent - EluNIR.

Being tested
EluNIR Ridaforolimus Eluting Coronary Stent System
Medical subject headings
Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EluNIR Ridaforolimus Eluting Coronary Stent SystemCombination product

    The EluNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising of:

    • Stent - a mounted Cobalt Chromium (CoCr) alloy based stent - 38 mm length and 2.75mm, 3.0 mm, 3.5mm, 4.0mm diameter
    • Delivery System - Rapid Exchange (RX) Coronary System
    • Polymer matrix coating - (PBMA) and CarboSil®
    • Ridaforolimus drug
Study groups in NCT03702608
Study groupRoleWhat they receive
EluNIR 38mmOtherNot described
Receives: Combination Product: EluNIR Ridaforolimus Eluting Coronary Stent System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Endpoint: Device Success

    Device success is defined as achievement of a final in-stent residual diameter stenosis of <50% (by QCA), using the assigned device only and without a device malfunction.

    Measured: 30 day

  2. Primary Endpoint: No 30 Day MACE (Major Adverse Cardiac Events)

    No 30 day MACE: MACE (Major Adverse Cardiac Events) is defined as the composite of cardiac death, any MI, or ischemia-driven TLR.

    Measured: 30 Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2018
  2. Study start14 Nov 2018
  3. Primary completion1 Mar 2019
  4. Study completion30 Apr 2020

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03702608
Sponsor's protocol ID
EluNIR-004
Status last verified
May 2020
First submitted
2 Sep 2018
Last updated
28 Oct 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Jonas M, Ben-Yehuda O, Banai S, Segev A, Danenberg H, Assali A, Tuvali O, Haberman D, Chernin G. Percutaneous coronary intervention with ridaforolimus-eluting stents in long lesions: the BIONICS 38 mm prospective trial. Coron Artery Dis. 2023 Sep 1;34(6):410-414. doi: 10.1097/MCA.0000000000001264. Epub 2023 Jul 4.

    PubMed 37471280

Questions about this trial

What is this clinical trial studying?

A study testing EluNIR Ridaforolimus Eluting Coronary Stent System in people with Coronary Stenosis, run by Medinol Ltd. at 1 site in Israel.

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 34 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 28 Oct 2020. 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 Israel. 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 28 Oct 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?

Primary Endpoint: Device Success (time frame: 30 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03702608, which also lists 1 linked publication.

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 28 Oct 2020.

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