Status:
TERMINATED
ChampioNIR® SFA Stent EFS Study
Lead Sponsor:
Medinol Ltd.
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
An Early Feasibility Study to Assess Safety and Efficacy of the ChampioNIR® SFA Stent in the Treatment of Patients with Femoro-Popliteal Disease
Detailed Description
Device Overview: The ChampioNIR® SFA Stent is composed of a Nitinol alloy structure with an elastomeric micro-fiber mesh and is designed specifically to be used in the peripheral vasculature. The ste...
Eligibility Criteria
Inclusion
- Age ≥ 18 years and of age of legal consent.
- Subject has lifestyle limiting claudication or rest pain (Rutherford-Becker scale 2-4) with a resting ankle-brachial index/toe-brachial index (ABI/TBI) \<0.90/0.80.
- A single superficial femoral artery lesion with \>50% stenosis or total occlusion.
- Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) ≥ 40 mm to ≤ 140 mm.
- Reference vessel diameter (RVD) ≥ 3.0 mm and ≤ 6.0 mm by visual assessment.
- Target lesion located with the distal point at least 3 cm above the knee joint, defined as the distal end of the femur at the knee joint, and proximal point at least 2 cm below the origin of the profunda femoris (deep femoral artery).
- Patent infra-popliteal and popliteal artery, i.e., single vessel runoff or better with at least one of three vessels patent (\<50% stenosis) to the ankle or foot.
- The target lesion(s) can be successfully crossed with a guide wire and dilated.
- The subject is eligible for standard surgical repair, if necessary.
- Subjects are willing to comply with scheduled visits and tests and are able and willing to provide informed consent.
Exclusion
- Thrombophlebitis or deep venous thrombus, within the previous 30 days.
- Presence of thrombus in the treated vessel as visualized by angiography, prior to crossing the lesion.
- Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
- Poor aortoiliac or common femoral "inflow" (i.e. angiographically defined \>50% stenosis of the iliac or common femoral artery) that would be deemed inadequate to support a femoro-popliteal bypass graft and was not successfully treated prior to treatment of the target lesion.
- Presence of residual ≥30% stenosis after either PTA or stenting of the inflow lesion.
- Presence of an ipsilateral arterial artificial graft.
- Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.
- Lesions in contralateral SFA/PPA that require intervention during the index procedure, or within 30 days before or after the index procedure;
- Required stent placement (in the target or any other lesion) via a retrograde approach.
- Required stent placement (in the target or any other lesion) across or within 0.5 cm of the SFA / PFA bifurcation.
- Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as in-stent restenosis.
- Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.
- Required stent placement within 1 cm of a previously (in a former procedure) deployed stent.
- Use of atherectomy or other atheroablative (e.g. cryoplasty) devices at the time of index procedure.
- Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty within 3 months of the index procedure.
- Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.
- Coronary intervention within 7 days prior to or planned within 30 days after the treatment of the target lesion.
- Stroke within the previous 90 days.
- Known allergies to any of the following: aspirin, P2Y12 inhibitors (clopidogrel bisulfate, prasugrel, OR ticagrelor), heparin OR bivalirudin, nitinol (nickel titanium), or contrast agent, that cannot be medically managed.
- Receiving dialysis or immunosuppressant therapy within the previous 30 days.
- Known or suspected active infection at the time of the procedure.
- History of neutropenia, coagulopathy, or thrombocytopenia.
- Known bleeding or hypercoagulability disorder or significant anemia (Hb\<8.0) that cannot be corrected.
- Platelet count \<80,000/μL
- International normalized ratio (INR) \> 1.5
- GFR \<30 ml/min by Cockroft-Gault.
- Subject requires general anesthesia for the procedure.
- Subject has a co-morbid illness that may result in a life expectancy of less than 1 year
- Planned use of a drug coated balloon (DCB) during the index procedure.
- Pregnant women or women of child bearing potential who do not have a negative serum or urine pregnancy test documented within 7 days prior to enrollment;
- Subject is participating in any investigational study that has not yet reached its primary endpoint.
Key Trial Info
Start Date :
October 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2023
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03775226
Start Date
October 27 2019
End Date
January 30 2023
Last Update
October 3 2023
Active Locations (3)
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1
Hadassah Medical Center
Jerusalem, Israel
2
Rabin Medical Center
Petah Tikva, Israel
3
Sourasky Medical Center
Tel Aviv, Israel