Coronary StenosisNCT03877848
EluNIR Ridaforolimus Eluting Coronary Stent System in Patients at High Bleeding Risk (HBR)- EluNIR HBR Study
An observational study of Coronary Stenosis, run by Medinol Ltd. at 1 site in Israel.
Trial summary
The study will enroll approximately 316 subjects with a wide spectrum of PCI indications (stable angina as well as ACS), who are considered to be at high risk of bleeding. Patients will undergo PCI with implantation of the EluNIR stent, followed by shortened duration (1 months in stable patients, and up to 3 months in… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Coronary Stenosis
- What is being tested?
- Percutaneous Coronary Intervention (PCI)
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 319 participants
- Where
- 1 siteIsrael
- Study dates
- 6 May 2019to 10 Jun 2021
- How long will I take part?
- 1 Year
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: High bleeding risk subjects undergoing PCI using the EluNIR stent for angina, silent ischemia or non STEMI.
Who may be able to join
- All inclusion criteria must be present for the patient to be eligible for enrollment.
- General Inclusion Criteria
- Age ≥ 18 years.
- Patient with angina (stable or unstable), silent ischemia or NSTEMI, undergoing PCI using the EluNIR stent.
- Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule.
- In addition, patients must meet at least one of the following criteria for high risk of bleeding:
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- Age ≥75 years
- Oral anticoagulation planned to continue after PCI
- Hemoglobin <11 g/liter or anemia requiring transfusion within 12 weeks before enrollment to the study
- Platelet count< 100,000/mm³
- Hospital admission for bleeding in previous 12 months
- Stroke in previous 12 months
- Previous intracerebral hemorrhage
- Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
- Renal failure defined as creatinine clearance< 40 ml/min
- Non-skin cancer diagnosed or treated < 3 years
- Planned surgery within 12 months that would require interruption of DAPT
- Planned daily NSAID (other than aspirin) or steroids for > 30 days after PCI
- Expected nonadherence to >30 days of dual antiplatelet therapy in stable patients and >3 months in ACS patients
- Angiographic inclusion criteria (visual estimate)
- 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, bifurcation lesions (except planned dual stent implantation), ostial RCA lesions, tortuous lesions, bare metal stent restenotic lesions, protected left main lesions, and saphenous vein graft lesions.
- Up to 2 overlapping stents are allowed (ie, one overlap)
Who cannot join
- All exclusion criteria must be absent for the patient to be eligible for enrollment.
- General Exclusion Criteria
- Pregnant and breastfeeding women
- Patients requiring a planned staged PCI with a non-study stent
- Patients expected not to comply with 1-month DAPT.
- Patients expected not to comply with long-term single anti-platelet therapy
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- PCI during the previous 12 months with a non-study stent
- 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%.
- White blood cell (WBC) count <3,000 cells/mm3.
- Active bleeding from any site at time of inclusion
- 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 <12 months (e.g. cancer, severe heart failure, severe lung disease).
- Patient has received an organ transplant or is on a waiting list for an organ transplant.
- Participation in another clinical trial that has not reached its primary endpoint.
- Angiographic Exclusion Criteria (visual estimate)
- Visually estimated RVD<2.5 mm or >4.25mm.
- Unprotected left main intervention.
- Ostial LAD and/or LCx intervention
- Bifurcation lesions with dual stent implantation.
- Stenting of lesions due to DES restenosis.
- Total stented length > 60 mm
- Planned implantation of any DES which is not EluNIR
- Note: In case the procedure required the unplanned implantation of a different (non-EluNIR) stent the subject will be de-registered from the study.
Trial locations and contacts
1 site in 1 country.
About this study
The study will enroll approximately 316 subjects with a wide spectrum of PCI indications (stable angina as well as ACS), who are considered to be at high risk of bleeding. Patients will undergo PCI with implantation of the EluNIR stent, followed by shortened duration (1 months in stable patients, and up to 3 months in ACS patients) of DAPT.
Read the detailed description
This is a prospective, multi-center (Up to 20 sites), single-arm, open-label post marketing clinical trial.
The objectives: To assess the safety and efficacy of shortened DAPT duration (30 days in stable patients and up to 90 days in ACS patients) following PCI using the EluNIR stent, in patients considered to be at high bleeding risk (HBR).
Patients will be enrolled to the study prior to the PCI procedure.Once a patient has signed an informed consent, met all general and angiographic eligibility criteria, and a guidewire has successfully been passed beyond the target lesion and lesion preparation (if indicated) completed, the patient will be enrolled into the trial.Data collection commences after the subject has signed the informed consent form. Data collection including subject demographic information, laboratory tests, and procedural data as well as follow-up visits or telephone contacts will be captured by the Investigator or site coordinator who has been trained on the CIP and Case Report Forms (CRF).
After discharge from the hospital, each subject will be followed with an in-clinic follow-up visit at 30 days, and follow-up by phone at 6 months and 1year post procedure. Patients with recurrent ischemic events within the first 30 days as well as patients in whom the initial presentation was ACS and in whom the investigator has decided to continue DAPT beyond 30 days will have an additional phone follow-up at 3 months.
The clinical investigation will last for the expected duration of each subject's participation.
Each subject will remain in the clinical investigation for approximately 1 year from the time of the study stent implantation until the last follow-up telephone contact.
The trial population will consist of approximately 316 male and female subjects undergoing PCI for angina (stable or unstable), silent ischemia, non-ST elevation MI (NSTEMI) considered at HBR.
- Conditions
- Coronary Stenosis
- Being tested
- Percutaneous Coronary Intervention (PCI)
- Keywords
- bleeding, PCI
- Medical subject headings
- Coronary Stenosis, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary Intervention (PCI)Device
Patients enrolled to the study will undergo angiography followed by PCI according to current guidelines.
| Study group | Role | What they receive |
|---|---|---|
| ACS and Non-ACS | DAPT will be stopped at 30 days in non-ACS subjects while at ACS Patients it may be maintained for up to 3 months. In patients with ACS or with an ischemic event during the first 30 days, DAPT may be continued at the discretion of the investigator. In ACS patients DAPT should be continued for a maximum of 3 months. For patients with recurrent ischemic events duration of DAPT therapy will be at the discretion of the investigator.
Patients receiving long-term oral anticoagulation with either a Vitamin K inhibitor or a NOAC/DOAC will receive either single antiplatelet therapy with clopidogrel, or DAPT for 30 days (triple therapy) followed by single antiplatelet therapy with clopidogrel. Clopidogrel (75 mg QD) will be given to these patients post procedure for 6 months in stable patients and 12 months in ACS patients. Receives: Device: Percutaneous Coronary Intervention (PCI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year (ARC definite and probable)
Measured: 1 Year
Secondary outcomes (13)
TLF, defined as the composite of cardiac death, target vessel-related MI, or ischemia-driven TLR.
Measured: To be evaluated at 30 days, 6 months, and 1 year
Major adverse cardiac events (MACE; the composite rate of cardiac death, any MI or ischemia-driven TLR)
Measured: To be evaluated at 30 days, 6 months, and 1 year
Target vessel failure (TVF; the composite rate of death, target vessel related MI or ischemia-driven TVR)
Measured: To be evaluated at 30 days, 6 months, and 1 year
The composite of cardiac death, myocardial infarction, or stent thrombosis at 30 days and 6 months
Measured: To be evaluated at 30 days, 6 months, and 1 year
All-cause mortality
Measured: To be evaluated at 30 days, 6 months, and 1 year
Cardiac death
Measured: To be evaluated at 30 days, 6 months, and 1 year
Bleeding events according to BARC definitions
Measured: To be evaluated at 30 days, 6 months, and 1 year
Myocardial Infarction
Measured: To be evaluated at 30 days, 6 months, and 1 year
Target Vessel Related MI
Measured: To be evaluated at 30 days, 6 months, and 1 year
Ischemia-driven TLR
Measured: To be evaluated at 30 days, 6 months, and 1 year
Ischemia-driven TVR
Measured: To be evaluated at 30 days, 6 months, and 1 year
Stent Thrombosis (ARC definite and probable)
Measured: To be evaluated at 30 days, 6 months, and 1 year
Bleeding complications (BARC definitions), evaluated as components and as a composite of BARC Type 3 and 5 bleeding
Measured: To be evaluated at 30 days, 6 months, and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2019
- Study start6 May 2019
- Primary completion10 Jun 2021
- Study completion10 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 319 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Medinol Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03877848
- Sponsor's protocol ID
- EluNIR HBR study
- Status last verified
- Aug 2021
- First submitted
- 14 Mar 2019
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kornowski R, Konigstein M, Jonas M, Assali A, Vaknin-Assa H, Segev A, Danenberg H, Halabi M, Roguin A, Kerner A, Lev E, Karamasis GV, Johnson TW, Anderson R, Blaxill J, Jadhav S, Hoole S, Witberg G, Issever MO, Ben-Yehuda O, Baumbach A. Percutaneous Coronary Interventions Using a Ridaforolimus-Eluting Stent in Patients at High Bleeding Risk. J Am Heart Assoc. 2024 Jan 16;13(2):e029051. doi: 10.1161/JAHA.122.029051. Epub 2024 Jan 12.
PubMed 38214256
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EluNIR Ridaforolimus Eluting Coronary Stent System in Patients at High Bleeding Risk (HBR)- EluNIR HBR Study
- ClinicalTrials.gov ID
- NCT03877848
- Acronym / sponsor ID
- EluNIR HBR study
- Conditions
- Coronary Stenosis
- Keywords
- bleeding, PCI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 319 participants (actual)
- Lead sponsor
- Medinol Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 May 2019 (actual)
- Primary completion
- 10 Jun 2021 (actual)
- Study completion
- 10 Jun 2021 (actual)
- First posted
- 18 Mar 2019 (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.
The study will enroll approximately 316 subjects with a wide spectrum of PCI indications (stable angina as well as ACS), who are considered to be at high risk of bleeding. Patients will undergo PCI with implantation of the EluNIR stent, followed by shortened duration (1 months in stable patients, and up to 3 months in ACS patients) of DAPT.
Detailed description
This is a prospective, multi-center (Up to 20 sites), single-arm, open-label post marketing clinical trial.
The objectives: To assess the safety and efficacy of shortened DAPT duration (30 days in stable patients and up to 90 days in ACS patients) following PCI using the EluNIR stent, in patients considered to be at high bleeding risk (HBR).
Patients will be enrolled to the study prior to the PCI procedure.Once a patient has signed an informed consent, met all general and angiographic eligibility criteria, and a guidewire has successfully been passed beyond the target lesion and lesion preparation (if indicated) completed, the patient will be enrolled into the trial.Data collection commences after the subject has signed the informed consent form. Data collection including subject demographic information, laboratory tests, and procedural data as well as follow-up visits or telephone contacts will be captured by the Investigator or site coordinator who has been trained on the CIP and Case Report Forms (CRF).
After discharge from the hospital, each subject will be followed with an in-clinic follow-up visit at 30 days, and follow-up by phone at 6 months and 1year post procedure. Patients with recurrent ischemic events within the first 30 days as well as patients in whom the initial presentation was ACS and in whom the investigator has decided to continue DAPT beyond 30 days will have an additional phone follow-up at 3 months.
The clinical investigation will last for the expected duration of each subject's participation.
Each subject will remain in the clinical investigation for approximately 1 year from the time of the study stent implantation until the last follow-up telephone contact.
The trial population will consist of approximately 316 male and female subjects undergoing PCI for angina (stable or unstable), silent ischemia, non-ST elevation MI (NSTEMI) considered at HBR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ACS and Non-ACS | – | Device: Percutaneous Coronary Intervention (PCI)DAPT will be stopped at 30 days in non-ACS subjects while at ACS Patients it may be maintained for up to 3 months. In patients with ACS or with an ischemic event during the first 30 days, DAPT may be continued at the discretion of the investigator. In ACS patients DAPT should be continued for a maximum of 3 months. For patients with recurrent ischemic events duration of DAPT therapy will be at the discretion of the investigator. Patients receiving long-term oral anticoagulation with either a Vitamin K inhibitor or a NOAC/DOAC will receive either single antiplatelet therapy with clopidogrel, or DAPT for 30 days (triple therapy) followed by single antiplatelet therapy with clopidogrel. Clopidogrel (75 mg QD) will be given to these patients post procedure for 6 months in stable patients and 12 months in ACS patients. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- High bleeding risk subjects undergoing PCI using the EluNIR stent for angina, silent ischemia or non STEMI.
Key inclusion criteria (22 listed)
- All inclusion criteria must be present for the patient to be eligible for enrollment.
- General Inclusion Criteria
- Age ≥ 18 years.
- Patient with angina (stable or unstable), silent ischemia or NSTEMI, undergoing PCI using the EluNIR stent.
- Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule.
Key exclusion criteria (26 listed)
- All exclusion criteria must be absent for the patient to be eligible for enrollment.
- General Exclusion Criteria
- Pregnant and breastfeeding women
- Patients requiring a planned staged PCI with a non-study stent
- Patients expected not to comply with 1-month DAPT.
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 |
|---|---|---|
| Percutaneous Coronary Intervention (PCI)Patients enrolled to the study will undergo angiography followed by PCI according to current guidelines. | Device | ACS and Non-ACS |
Primary outcome
The composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year (ARC definite and probable)
Time frame: 1 Year
13 secondary outcomes
TLF, defined as the composite of cardiac death, target vessel-related MI, or ischemia-driven TLR.
Time frame: To be evaluated at 30 days, 6 months, and 1 year
Major adverse cardiac events (MACE; the composite rate of cardiac death, any MI or ischemia-driven TLR)
Time frame: To be evaluated at 30 days, 6 months, and 1 year
Target vessel failure (TVF; the composite rate of death, target vessel related MI or ischemia-driven TVR)
Time frame: To be evaluated at 30 days, 6 months, and 1 year
The composite of cardiac death, myocardial infarction, or stent thrombosis at 30 days and 6 months
Time frame: To be evaluated at 30 days, 6 months, and 1 year
All-cause mortality
Time frame: To be evaluated at 30 days, 6 months, and 1 year
Cardiac death
Time frame: To be evaluated at 30 days, 6 months, and 1 year
Bleeding events according to BARC definitions
Time frame: To be evaluated at 30 days, 6 months, and 1 year
Myocardial Infarction
Time frame: To be evaluated at 30 days, 6 months, and 1 year
Target Vessel Related MI
Time frame: To be evaluated at 30 days, 6 months, and 1 year
Ischemia-driven TLR
Time frame: To be evaluated at 30 days, 6 months, and 1 year
Ischemia-driven TVR
Time frame: To be evaluated at 30 days, 6 months, and 1 year
Stent Thrombosis (ARC definite and probable)
Time frame: To be evaluated at 30 days, 6 months, and 1 year
Bleeding complications (BARC definitions), evaluated as components and as a composite of BARC Type 3 and 5 bleeding
Time frame: To be evaluated at 30 days, 6 months, and 1 year
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 1 Sep 2021.
- Derived from this study: PubMed 38214256Kornowski R, Konigstein M, Jonas M, Assali A, Vaknin-Assa H, Segev A, Danenberg H, Halabi M, Roguin A, Kerner A, Lev E, Karamasis GV, Johnson TW, Anderson R, Blaxill J, Jadhav S, Hoole S, Witberg G, Issever MO, Ben-Yehuda O, Baumbach A. Percutaneous Coronary Interventions Using a Ridaforolimus-Eluting Stent in Patients at High Bleeding Risk. J Am Heart Assoc. 2024 Jan 16;13(2):e029051. doi: 10.1161/JAHA.122.029051. Epub 2024 Jan 12.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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, 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 22 inclusion and 26 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 1 Sep 2021. 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?
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?
The composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year (ARC definite and probable) (time frame: 1 Year). 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 NCT03877848, 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 1 Sep 2021.