Clinical trial NCT04761939: BIONICS Small Vessels Trial EluNIR Ridaforolimus Eluting Coronary Stent System (EluNIR) in Coronary Stenosis Trial
Official title: BIONICS Small Vessels Trial EluNIR Ridaforolimus Eluting Coronary Stent System (EluNIR) in Coronary Stenosis Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Cardiovascular Diseases
Lead sponsor: Medinol Ltd.
Sponsor class: INDUSTRY
First posted: 2021-02-21
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

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:

1. 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.
2. Less than 24 hours prior to Index Procedure:

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.

ii. 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.

iii. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling.

d. 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

Exclusion Criteria:

1. 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.
2. PCI within the 24 hours preceding the index procedure.
3. Non-target lesion PCI in the target vessel 24 hours to 30 days.
4. Planned staged procedures.
5. Brachytherapy in conjunction with the index procedure.
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. 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).
11. eGFR \<30 mL/min
12. Hemoglobin \<10 g/dL.
13. Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3.
14. White blood cell (WBC) count \<3,000 cells/mm3.
15. Clinically significant liver disease.
16. Active peptic ulcer or active bleeding from any site.
17. Bleeding from any site within the prior 8 weeks requiring active medical or surgical attention.
18. If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath.
19. History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
20. Cerebrovascular accident or transient ischemic attack within the past 6 months, or any permanent neurologic defect attributed to CVA.
21. 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).
22. 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.
23. 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).
24. Patient is participating in or plans to participate in any other investigational drug or device clinical trial that has not reached its primary endpoint.
25. Women who are pregnant or breastfeeding.
26. 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).
27. Patient has received an organ transplant or is on a waiting list for an organ transplant.
28. Patient is receiving or scheduled to receive chemotherapy within 30 days before or any time after the index procedure.
29. 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):
30. Unprotected left main lesions ≥30%, or planned left main intervention.
31. Bifurcation lesions with planned dual stent implantation.
32. Stenting of lesions due to DES restenosis.
33. Occlusive thrombus and/or a thrombus requiring thrombectomy in a target vessel
34. 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.

Primary outcomes:
measure: MACE
timeFrame: At 30 days
measure: TLF
timeFrame: At 6 month
Secondary outcomes:
measure: TLF
timeFrame: 6 Months and 1 Year
measure: Device success
timeFrame: 30 Days, 6 Months & 1 Year
measure: Lesion success
timeFrame: 30 Days, 6 Months & 1Year
measure: Procedure success
timeFrame: 30 Days, 6 Months & 1Year
measure: Target vessel failure
timeFrame: 30 Days, 6 Months & 1 Year
measure: Major adverse cardiac events
timeFrame: 30 Days, 6 Months & 1Year
measure: All-cause mortality
timeFrame: 30 Days, 6 Months & 1 Year
measure: Cardiac death
timeFrame: 30 Days, 6 Months & 1Year
measure: MI
timeFrame: 30 Days, 6 Months & 1Year
measure: Target vessel related MI
timeFrame: 30 Days, 6 Months & 1 Year
measure: Ischemia-driven TLR
timeFrame: 30 Days, 6 Months & 1 Year
measure: Ischemia-driven TVR
timeFrame: 30 Days, 6 Months & 1Year
measure: Stent thrombosis
timeFrame: 30 Days, 6Months & 1Year
Other outcomes:
Locations:
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
city: Hadera
country: Israel
facility: Hillel Yafe Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Holon
country: Israel
facility: Wolfson Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Petah tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
Study officials:
affiliation: Sponsor GmbH
name: Yoram Richter, PhD
role: STUDY_DIRECTOR
References: