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EluNIR Ridaforolimus Eluting Coronary Stent System in Patients at High Bleeding Risk (HBR)- EluNIR HBR Study

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ClinicalTrials.gov Identifier: NCT03877848
Recruitment Status : Not yet recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Medinol Ltd.

Brief 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 ACS patients) of DAPT.

Condition or disease Intervention/treatment
Coronary Stenosis Device: Percutaneous Coronary Intervention (PCI)

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 316 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: EluNIR Ridaforolimus Eluting Coronary Stent System in Patients at High Bleeding Risk (HBR)- EluNIR HBR Study
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort Intervention/treatment
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.

Device: Percutaneous Coronary Intervention (PCI)
Patients enrolled to the study will undergo angiography followed by PCI according to current guidelines.




Primary Outcome Measures :
  1. The composite of cardiac death, myocardial infarction, or stent thrombosis at 1 year (ARC definite and probable) [ Time Frame: 1 Year ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. All-cause mortality [ Time Frame: To be evaluated at 30 days, 6 months, and 1 year ]
  6. Cardiac death [ Time Frame: To be evaluated at 30 days, 6 months, and 1 year ]
  7. Bleeding events according to BARC definitions [ Time Frame: To be evaluated at 30 days, 6 months, and 1 year ]
  8. Myocardial Infarction [ Time Frame: To be evaluated at 30 days, 6 months, and 1 year ]
  9. Target Vessel Related MI [ Time Frame: To be evaluated at 30 days, 6 months, and 1 year ]
  10. Ischemia-driven TLR [ Time Frame: To be evaluated at 30 days, 6 months, and 1 year ]
  11. Ischemia-driven TVR [ Time Frame: To be evaluated at 30 days, 6 months, and 1 year ]
  12. Stent Thrombosis (ARC definite and probable) [ Time Frame: To be evaluated at 30 days, 6 months, and 1 year ]
  13. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
High bleeding risk subjects undergoing PCI using the EluNIR stent for angina, silent ischemia or non STEMI.
Criteria

Inclusion Criteria:

All inclusion criteria must be present for the patient to be eligible for enrollment.

General Inclusion Criteria

  1. Age ≥ 18 years.
  2. Patient with angina (stable or unstable), silent ischemia or NSTEMI, undergoing PCI using the EluNIR stent.
  3. 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:

  1. Age ≥75 years
  2. Oral anticoagulation planned to continue after PCI
  3. Hemoglobin <11 g/liter or anemia requiring transfusion within 12 weeks before enrollment to the study
  4. Platelet count< 100,000/mm³
  5. Hospital admission for bleeding in previous 12 months
  6. Stroke in previous 12 months
  7. Previous intracerebral hemorrhage
  8. Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice
  9. Renal failure defined as creatinine clearance< 40 ml/min
  10. Non-skin cancer diagnosed or treated < 3 years
  11. Planned surgery within 12 months that would require interruption of DAPT
  12. Planned daily NSAID (other than aspirin) or steroids for > 30 days after PCI
  13. Expected nonadherence to >30 days of dual antiplatelet therapy in stable patients and >3 months in ACS patients

Angiographic inclusion criteria (visual estimate)

  1. 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.
  2. Up to 2 overlapping stents are allowed (ie, one overlap)

Exclusion Criteria:

All exclusion criteria must be absent for the patient to be eligible for enrollment.

General Exclusion Criteria

  1. Pregnant and breastfeeding women
  2. Patients requiring a planned staged PCI with a non-study stent
  3. Patients expected not to comply with 1-month DAPT.
  4. Patients expected not to comply with long-term single anti-platelet therapy
  5. PCI during the previous 12 months with a non-study stent
  6. History of stent thrombosis
  7. 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.
  8. Subject is intubated.
  9. Known LVEF <30%.
  10. White blood cell (WBC) count <3,000 cells/mm3.
  11. Active bleeding from any site at time of inclusion
  12. 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.
  13. 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).
  14. Patient has received an organ transplant or is on a waiting list for an organ transplant.
  15. Participation in another clinical trial that has not reached its primary endpoint.

Angiographic Exclusion Criteria (visual estimate)

  1. Visually estimated RVD<2.5 mm or >4.25mm.
  2. Unprotected left main intervention.
  3. Ostial LAD and/or LCx intervention
  4. Bifurcation lesions with dual stent implantation.
  5. Stenting of lesions due to DES restenosis.
  6. Total stented length > 60 mm
  7. 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03877848


Contacts
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Contact: Iren Basanov 052-6936695 irenb@MEDINOL.COM

Sponsors and Collaborators
Medinol Ltd.

Additional Information:

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Responsible Party: Medinol Ltd.
ClinicalTrials.gov Identifier: NCT03877848     History of Changes
Other Study ID Numbers: EluNIR HBR study
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Medinol Ltd.:
bleeding
PCI

Additional relevant MeSH terms:
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Hemorrhage
Coronary Stenosis
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases