Coronary StenosisNCT04761939
BIONICS Small Vessels Trial EluNIR Ridaforolimus Eluting Coronary Stent System (EluNIR) in Coronary Stenosis Trial
An observational study of Coronary Stenosis and Coronary Disease, run by Medinol Ltd. at 9 sites in Israel.
Trial summary
Device: EluNIR Ridaforolimus Eluting Coronary Stent System - (hereafter referred to as EluNIR) 2.25 mm diameter (8 mm, 12 mm, 15 mm, 17 mm, 20 mm, 24 mm, 28 mm and 33 mm length) Objectives: To further assess the safety and efficacy of the small diameter (2.25 mm) Ridaforolimus Eluting Stent - EluNIR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Stenosis, Coronary Disease, Myocardial Ischemia
- What is being tested?
- EluNIR Ridaforolimus Eluting Coronary Stent System
- How many people
- 81 participants
- Where
- 9 sitesIsrael
- Study dates
- 31 Dec 2020to 20 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: Subjects who underwent 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 STEMI (>24 hours from initial presentation and stable) with attempted implantation of a 2.25 mm diameter EluNIR stent.
Who may be able to join
- Age ≥ 18 years. 2. 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.
- 3. An attempt (whether successful or not) was made to implant a 2.25 mm EluNIR stent (Stent was advanced beyond the guiding catheter).
- 4. Non-target lesion PCIs are allowed depending on the time interval and conditions as follows:
- During Index Procedure:
- 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 Index Procedure:
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- Not allowed (see exclusion criteria #2). c. 24 hours-30 days prior to Index Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to the index procedure if successful and uncomplicated as defined above.
- In addition, in cases where non-target vessel PCI has occurred 24-72 hours prior to the index 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 Index Procedure: PCI of non-target lesions performed greater than 30 days prior to index procedure whether or not successful and uncomplicated.
- 5. 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):
- 6. Target lesion(s) must be located in a native coronary artery or bypass graft conduit with visually estimated diameter of ≥2.25 mm to ≤2.5 mm.
- 7. 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.
- 8. Overlapping stents are allowed as long as at least one of the stents implanted is the EluNIR 2.25 mm diameter stent
Who cannot join
- 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 index procedure.
- Non-target lesion PCI in the target vessel 24 hours to 30 days.
- Planned staged procedures.
- Brachytherapy in conjunction with the index procedure.
- History of stent thrombosis.
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- 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 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 index 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 index 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 index 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 index procedure.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Israel9 sites
Soroka Medical Center
Beersheba
Hillel Yafe Medical Center
Hadera
Rambam Medical Center
Haifa
Wolfson Medical Center
Holon
Meir Medical Center
Kfar Saba
Rabin Medical Center
Petah Tikva
Sheba Medical Center
Ramat Gan
Kaplan Medical Center
Rehovot
Sourasky Medical Center
Tel Aviv
About this study
Device:
EluNIR Ridaforolimus Eluting Coronary Stent System - (hereafter referred to as EluNIR) 2.25 mm diameter (8 mm, 12 mm, 15 mm, 17 mm, 20 mm, 24 mm, 28 mm and 33 mm length)
Read more
Objectives:
To further assess the safety and efficacy of the small diameter (2.25 mm) Ridaforolimus Eluting Stent - EluNIR.
Subject Population:
Subjects who underwent 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 STEMI (>24 hours from initial presentation and stable) with attempted implantation of a 2.25 mm diameter EluNIR stent.
Trial Design and Methods:
This is a prospective, multi-center, single-arm, open-label clinical trial. Clinical follow-up for all patients will be performed at 30 days 6 months, and 1 year after the procedure.
- Being tested
- EluNIR Ridaforolimus Eluting Coronary Stent System
- Medical subject headings
- Coronary Stenosis, Coronary Disease, Myocardial Ischemia, Cardiovascular Diseases
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 pre-mounted Cobalt Chromium (CoCr) alloy based stent - 2.25 mm Diameter and 8mm, 12mm, 15mm, 17mm, 20mm, 24mm, 28mm and 33mm length
- Delivery System - Rapid Exchange (RX) Coronary System
- Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil®
- Ridaforolimus drug - CAS Registry Number: 572924-54-0
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
Combined early efficacy and safety endpoint:
MACE at 30 days for all patients enrolled. MACE is defined as the composite of cardiac death, any MI, or ischemia-driven TLR.
Measured: At 30 days
TLF
Combined late efficacy and safety endpoint:
Target Lesion Failure (TLF) at 6 months (evaluated for the first 50% of patients enrolled) Defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization.
Measured: At 6 month
Secondary outcomes (13)
TLF
Target Lesion Failure at 6 months (for all patients enrolled) and 1 year
Measured: 6 Months and 1 Year
Device success
Device success is defined as achievement of a final in-stent residual diameter stenosis of <30% (by QCA), using the EluNIR 2.25 mm stent only and without a device malfunction.
Measured: 30 Days, 6 Months & 1 Year
Lesion success
Lesion success is defined as achievement of a final in-stent residual diameter stenosis of <30% (by QCA) using any percutaneous method.
Measured: 30 Days, 6 Months & 1Year
Procedure success
Procedure success is defined as achievement of a final in-stent diameter stenosis of <30% (by QCA) using the assigned device and/or with any adjunctive devices, without the occurrence of cardiac death, Q wave or non-Q wave MI, or repeat revascularization of the target lesion during the hospital stay.
Measured: 30 Days, 6 Months & 1Year
Target vessel failure
TVF; the composite rate of death, target vessel related MI or ischemia-driven TVR)
Measured: 30 Days, 6 Months & 1 Year
Major adverse cardiac events
MACE; the composite rate of cardiac death, any MI or ischemia-driven TLR
Measured: 30 Days, 6 Months & 1Year
All-cause mortality
cardiac death, vascular death, non cardiac death
Measured: 30 Days, 6 Months & 1 Year
Cardiac death
Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Measured: 30 Days, 6 Months & 1Year
MI
Post-PCI (Type 4a) and post-CABG (Periprocedural) MIs (Type 5), Periprocedural MIs will be defined based on the SCAI definitions and Spontaneous MI (MI Type I) will be defined based on the Universal Definition of Myocardial Infarction
Measured: 30 Days, 6 Months & 1Year
Target vessel related MI
Target vessel related MI
Measured: 30 Days, 6 Months & 1 Year
Ischemia-driven TLR
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion
Measured: 30 Days, 6 Months & 1 Year
Ischemia-driven TVR
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel).
Measured: 30 Days, 6 Months & 1Year
Stent thrombosis
ARC definite and probable (Circulation 2007;115:2344-51)
Measured: 30 Days, 6Months & 1Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start31 Dec 2020
- Primary completion2 Nov 2021
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medinol Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoram Richter, PhD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04761939
- Sponsor's protocol ID
- EluNIR-005
- Status last verified
- Nov 2024
- First submitted
- 11 Oct 2020
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BIONICS Small Vessels Trial EluNIR Ridaforolimus Eluting Coronary Stent System (EluNIR) in Coronary Stenosis Trial
- ClinicalTrials.gov ID
- NCT04761939
- Acronym / sponsor ID
- EluNIR-005
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Medinol Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Dec 2020 (actual)
- Primary completion
- 2 Nov 2021 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 21 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Device:
EluNIR Ridaforolimus Eluting Coronary Stent System - (hereafter referred to as EluNIR) 2.25 mm diameter (8 mm, 12 mm, 15 mm, 17 mm, 20 mm, 24 mm, 28 mm and 33 mm length)
Objectives:
To further assess the safety and efficacy of the small diameter (2.25 mm) Ridaforolimus Eluting Stent - EluNIR.
Subject Population:
Subjects who underwent 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 STEMI (>24 hours from initial presentation and stable) with attempted implantation of a 2.25 mm diameter EluNIR stent.
Trial Design and Methods:
This is a prospective, multi-center, single-arm, open-label clinical trial. Clinical follow-up for all patients will be performed at 30 days 6 months, and 1 year after the procedure.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who underwent 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 STEMI (>24 hours from initial presentation and stable) with attempted implantation of a 2.25 mm diameter EluNIR stent.
Key inclusion criteria (15 listed)
- Age ≥ 18 years. 2. 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.
- 3. An attempt (whether successful or not) was made to implant a 2.25 mm EluNIR stent (Stent was advanced beyond the guiding catheter).
- 4. Non-target lesion PCIs are allowed depending on the time interval and conditions as follows:
- During Index Procedure:
- 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.
Key exclusion criteria (35 listed)
- 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 index procedure.
- Non-target lesion PCI in the target vessel 24 hours to 30 days.
- Planned staged procedures.
- Brachytherapy in conjunction with the index procedure.
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 |
|---|---|---|
| EluNIR Ridaforolimus Eluting Coronary Stent SystemThe EluNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising of: * Stent - a pre-mounted Cobalt Chromium (CoCr) alloy based stent - 2.25 mm Diameter and 8mm, 12mm, 15mm, 17mm, 20mm, 24mm, 28mm and 33mm length * Delivery System - Rapid Exchange (RX) Coronary System * Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil® * Ridaforolimus drug - CAS Registry Number: 572924-54-0 | Combination product | – |
Primary outcome
MACE
Time frame: At 30 days
Combined early efficacy and safety endpoint: MACE at 30 days for all patients enrolled. MACE is defined as the composite of cardiac death, any MI, or ischemia-driven TLR.
TLF
Time frame: At 6 month
Combined late efficacy and safety endpoint: Target Lesion Failure (TLF) at 6 months (evaluated for the first 50% of patients enrolled) Defined as the composite of cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization.
13 secondary outcomes
TLF
Time frame: 6 Months and 1 Year
Device success
Time frame: 30 Days, 6 Months & 1 Year
Lesion success
Time frame: 30 Days, 6 Months & 1Year
Procedure success
Time frame: 30 Days, 6 Months & 1Year
Target vessel failure
Time frame: 30 Days, 6 Months & 1 Year
Major adverse cardiac events
Time frame: 30 Days, 6 Months & 1Year
All-cause mortality
Time frame: 30 Days, 6 Months & 1 Year
Cardiac death
Time frame: 30 Days, 6 Months & 1Year
MI
Time frame: 30 Days, 6 Months & 1Year
Target vessel related MI
Time frame: 30 Days, 6 Months & 1 Year
Ischemia-driven TLR
Time frame: 30 Days, 6 Months & 1 Year
Ischemia-driven TVR
Time frame: 30 Days, 6 Months & 1Year
Stent thrombosis
Time frame: 30 Days, 6Months & 1Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
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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.
Yoram Richter, PhD study director
Sponsor GmbH
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Stenosis and Coronary Disease, run by Medinol Ltd. at 9 sites 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 15 inclusion and 35 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 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
MACE (time frame: At 30 days). 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?
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 21 Nov 2024.