Stenosis
Conditions
Brief summary
This study aims to assess the device success and the safety of Medinol's Drug Eluting Stent - BioNIR - with a modified delivery system. The BioNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising: * A mounted Cobalt Chromium (CoCr) alloy based stent * A Rapid Exchange (RX) delivery system * A polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil® * Ridaforolimus drug - CAS Registry Number: 572924-54-0 It is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to lesions in vessels with reference diameters of 2.5 mm to 4.25 mm, including complex lesions.
Detailed description
This is a prospective, multi-center, single arm, open label, clinical trial. Lesions planned to be treated must be declared and recorded at time of enrollment. Planned staged procedures, if necessary, must be declared immediately post procedure. Clinical follow-up will be performed at 30 days. Telephone follow-ups will be performed at 6 months and 1 year post procedure.
Interventions
DEVICEBioNIR Ridaforolimus Eluting Coronary Stent System
BioNIR Ridaforolimus eluting coronary stent system with modified delivery system
Sponsors
Medinol Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Non-target vessel PCI are allowed prior to enrollment depending on the time interval and conditions as follows: During Baseline Procedure: PCI of non-target vessels performed during the baseline procedure itself immediately prior to enrollment 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 Baseline Procedure: Not allowed (see
Exclusion criteria
#2). 24 hours-30 days prior to Baseline Procedure: PCI of non-target vessels 24 hours to 30 days prior to enrollment if successful and uncomplicated as defined above. 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 be 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 Baseline Procedure: a. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated. 3. 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): 4. Target lesion(s) must be located in a native coronary artery or bypass graft conduit with visually estimated diameter of ≥2.5 mm to ≤4.25 mm. 5. Complex lesions are allowed including calcified lesions (lesion preparation with scoring/cutting and rotational atherectomy are allowed), presence of thrombus, CTO, bifurcation lesions (except as noted in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Device Success in the Target Lesion as Determined by the Angiographic Core Laboratory | during baseline procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target Lesion Success | during baseline procedure | Lesion success is defined as achievement of a final in-stent residual diameter stenosis of \<50% (by QCA) using any percutaneous method. |
| Procedure Success | during baseline procedure | Procedure success is defined as achievement of a final in-stent diameter stenosis of \<50% (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. |
Other
| Measure | Time frame |
|---|---|
| Major Adverse Cardiac Events (MACE) | Clinical follow-up will be performed at 30 days. |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BioNIR Drug Eluting Stent System BioNIR Ridaforolimus eluting coronary stent system with modified delivery system
BioNIR Ridaforolimus Eluting Coronary Stent System: BioNIR Ridaforolimus eluting coronary stent system with modified delivery system | 58 |
| Total | 58 |
Baseline characteristics
| Characteristic | BioNIR Drug Eluting Stent System |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 26 Participants |
| Age, Categorical Between 18 and 65 years | 32 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 | 58 Participants |
| Region of Enrollment Israel | 58 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 58 |
| other Total, other adverse events | 16 / 58 |
| serious Total, serious adverse events | 3 / 58 |
Outcome results
Primary
Device Success in the Target Lesion as Determined by the Angiographic Core Laboratory
Time frame: during baseline procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BioNIR Drug Eluting Stent System | Device Success in the Target Lesion as Determined by the Angiographic Core Laboratory | 58 Participants |
Secondary
Procedure Success
Procedure success is defined as achievement of a final in-stent diameter stenosis of \<50% (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.
Time frame: during baseline procedure
Secondary
Target Lesion Success
Lesion success is defined as achievement of a final in-stent residual diameter stenosis of \<50% (by QCA) using any percutaneous method.
Time frame: during baseline procedure
Other Pre-specified
Major Adverse Cardiac Events (MACE)
Time frame: Telephone follow up will be performed at 6 months post procedure
Other Pre-specified
Major Adverse Cardiac Events (MACE)
Time frame: Telephone follow up will be performed at 1 year post procedure
Other Pre-specified
Major Adverse Cardiac Events (MACE)
Time frame: Clinical follow-up will be performed at 30 days.