Coronary Stenosis
Conditions
Brief 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. Study Objective is to further assess the safety and efficacy of long (38 mm) Ridaforolimus Eluting Stent - EluNIR.
Interventions
COMBINATION_PRODUCTEluNIR Ridaforolimus Eluting Coronary Stent System
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
Sponsors
Medinol Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* General Inclusion Criteria: 1. 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 38 mm EluNIR stent (Stent was advanced beyond the guiding catheter). 4. Non-target vessel PCI are allowed prior to the screening for eligibility depending on the time interval and conditions as follows: 1. During Baseline Procedure: 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. 2. 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. ii. 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. 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 Baseline Procedure: PCI of non-target vessels performed greater than 30 days prior to baseline 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 ≥2.75 mm to ≤4.25 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 the first stent implanted is the EluNIR 38 mm long stent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Endpoint: Device Success | 30 day | 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. |
| Primary Endpoint: No 30 Day MACE (Major Adverse Cardiac Events) | 30 Day | No 30 day MACE: MACE (Major Adverse Cardiac Events) is defined as the composite of cardiac death, any MI, or ischemia-driven TLR. |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| EluNIR 38mm Patients received the EluNIR Ridaforolimus Eluting Coronary Stent System: 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 | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | EluNIR 38mm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 23 Participants |
| Age, Categorical Between 18 and 65 years | 27 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 50 Participants |
| Region of Enrollment Israel | 50 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 49 |
| other Total, other adverse events | 15 / 49 |
| serious Total, serious adverse events | 5 / 49 |
Outcome results
Primary
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.
Time frame: 30 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EluNIR 38mm | Primary Endpoint: Device Success | 44 Participants |
Primary
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.
Time frame: 30 Day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EluNIR 38mm | Primary Endpoint: No 30 Day MACE (Major Adverse Cardiac Events) | 44 Participants |