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ChampioNIR® SFA Stent EFS Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03775226
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : August 14, 2020
Sponsor:
Information provided by (Responsible Party):
Medinol Ltd.

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

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: ChampioNIR® SFA Stent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Early Feasibility Study to Assess Safety and Efficacy of the ChampioNIR® SFA Stent in the Treatment of Patients With Femoro-Popliteal Disease
Actual Study Start Date : October 27, 2019
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : April 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single are
This study is designed as an early feasibility, prospective, open label, single arm study. 30 patients with infra-inguinal peripheral arterial disease appropriate for treatment with a femoro-popliteal stent will be treated with ChampioNIR® SFA stent implantation.
Device: ChampioNIR® SFA Stent
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 stent is characterized by high flexibility, strong radial support and high resistance to fractures, as well as high deliverability and precise positioning.
Other Name: ChampioNIR®




Primary Outcome Measures :
  1. Primary patency of the target lesion at 6 months. [ Time Frame: 6 months ]
    Primary patency is defined as the absence of target lesion restenosis (defined by Duplex ultrasound (US) peak systolic velocity ratio (PSVR) >2.4)

  2. Composite rate of freedom [ Time Frame: 30 Day ]
    from all-cause death, target vessel revascularization or any amputation of the index limb through 30 days following stent implantation.


Secondary Outcome Measures :
  1. Primary patency defined by Duplex US [ Time Frame: 30 days and 12 months. ]
    Primary patency defined by Duplex US peak systolic velocity ratio (absence of restenosis which defined by Duplex US PSVR >2.4

  2. Acute device success [ Time Frame: index procedure ]
    defined as achievement of a final residual diameter stenosis of <50% by Quantitative Angiography (QA), using the assigned treatment only.

  3. Acute procedural success [ Time Frame: index procedure ]
    defined as device success with <50% residual stenosis immediately after stent placement or mean trans-stenotic pressure gradient <5 mmHg, and without the occurrence of death, amputation or repeat revascularization of the target lesion during the hospital stay.

  4. Acute technical success [ Time Frame: index procedure ]
    defined as the attainment of <50% residual stenosis by QA by any percutaneous method as determined by the angiographic core laboratory.

  5. Secondary Patency absence of restenosis which is defined as Duplex US [ Time Frame: 30 days 6, 12, 24 and 36 months ]
    Secondary Patency (absence of restenosis which is defined as Duplex US PSVR ≥ 2.4)

  6. Combined rate 30 day [ Time Frame: 12 months ]
    of death at 30 days, target lesion revascularization (TVR), index limb amputation and increase in Rutherford-Becker Classification by ≥2 classes (as compared to post-procedural assessment)

  7. Stent fractures will be analyzed by a two-view X-ray evaluation by a designated core laboratory, compared with a baseline two-view X-ray taken before discharge and defined as type I, II, III, IV or V as follow [ Time Frame: 30 days 6, 12, 24 and 36 months ]
    • Type I - a single strut fracture only.
    • Type II - multiple single nitinol stent fractures that can occur at different sites.
    • Type III - multiple nitinol stent fractures resulting in complete transverse linear fracture but without stent displacement.
    • Type IV - a complete transverse linear type III fracture with stent displacement.
    • Type V - a spiral dissection of a stent.

  8. Freedom from all-cause death, index limb amputation above the ankle and TVR. [ Time Frame: 30 days ]
    Clinical: The number of patients who die from all causes

  9. All-cause death [ Time Frame: 30 days, 6, 12, 24 and 36 months ]
    Clinical: The number of patients who die from all causes

  10. The following Major Adverse Limb Events will be evaluated either by angiography or clinical examination. These will be assessed by reviewing angiograms by the core-lab and clinical events will be adjudicated by a CEC [ Time Frame: 30 days, 6, 12, 24 and 36 months ]
    1. Stent thrombosis
    2. Clinically apparent distal embolization (defined as causing end-organ damage, e.g. lower extremity ulceration, tissue necrosis, or gangrene)
    3. Procedure-related arterial rupture
    4. Acute limb ischemia
    5. Target limb amputation
    6. Procedure related bleeding event requiring transfusion

    These are clinical events, the unit of measure for all is - number of patients with any event


  11. Rutherford classification [ Time Frame: 30 days 6, 12, 24 and 36 months ]

    Change of Rutherford classification from baseline

    It is defined as follows, with increasing severity:

    1. - Mild Claudication - short duration
    2. - Moderate Claudication - moderate exercise
    3. - Severe Claudication - minor exertion
    4. - Rest Pain
    5. - Minor Tissue Loss
    6. - Major Tissue Loss

  12. resting ankle-brachial index [ Time Frame: 30 days 6, 12, 24 and 36 months ]

    Change of resting ankle-brachial index (ABI) from baseline

    Ankle Brachial Index (ABI) is a standard measure defined as:

    The systolic blood pressure at the ankle divided by the systolic blood pressure at the upper arm (brachial artery) A ratio below 0.9 is considered significant


  13. walking impairment questionnaire [ Time Frame: 30 days 6, 12, 24 and 36 months ]
    Change in walking impairment questionnaire from baseline The questionnaire will be used to assess walking capability in patients with Peripheral Arterial Disease (to evaluate the walking impairment and the efficacy of an intervention to improve walking ability in patients with Peripheral Arterial Disease, PAD).\ The patients will be required to address their walking difficulties and grade them on an increased severity scale.

  14. six minute walk test [ Time Frame: 30 days 6, 12, 24 and 36 months ]
    Change in six minute walk test from baseline

  15. Amputation (above the ankle) [ Time Frame: 30 days, 6, 12, 24 and 36 months ]
    Amputation (above the ankle)-Free Survival (AFS)

  16. Target Vessel Revascularization [ Time Frame: 30 days, 6, 12, 24 and 36 months ]
    Target Vessel Revascularization (TVR) Will be measured by the number of patients with the event

  17. Re-intervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature [ Time Frame: 30 days, 6, 12, 24 and 36 months ]
    Re-intervention for treatment of thrombosis of the target vessel or embolization to its distal vasculature Will be measured by the number of patients with the event



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 and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years and of age of legal consent.
  2. 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.
  3. A single superficial femoral artery lesion with >50% stenosis or total occlusion.
  4. Stenotic lesion(s) or occluded length within the same vessel (one long or multiple serial lesions) ≥ 40 mm to ≤ 140 mm.
  5. Reference vessel diameter (RVD) ≥ 3.0 mm and ≤ 6.0 mm by visual assessment.
  6. 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).
  7. 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.
  8. The target lesion(s) can be successfully crossed with a guide wire and dilated.
  9. The subject is eligible for standard surgical repair, if necessary.
  10. Subjects are willing to comply with scheduled visits and tests and are able and willing to provide informed consent.

Exclusion Criteria:

  1. Thrombophlebitis or deep venous thrombus, within the previous 30 days.
  2. Presence of thrombus in the treated vessel as visualized by angiography, prior to crossing the lesion.
  3. Thrombolysis of the target vessel within 72 hours prior to the index procedure, where complete resolution of the thrombus was not achieved.
  4. 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.
  5. Presence of residual ≥30% stenosis after either PTA or stenting of the inflow lesion.
  6. Presence of an ipsilateral arterial artificial graft.
  7. Ipsilateral femoral aneurysm or aneurysm in the SFA or popliteal artery.
  8. Lesions in contralateral SFA/PPA that require intervention during the index procedure, or within 30 days before or after the index procedure;
  9. Required stent placement (in the target or any other lesion) via a retrograde approach.
  10. Required stent placement (in the target or any other lesion) across or within 0.5 cm of the SFA / PFA bifurcation.
  11. Procedures which are pre-determined to require stent-in-stent placement to obtain patency, such as in-stent restenosis.
  12. Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device.
  13. Required stent placement within 1 cm of a previously (in a former procedure) deployed stent.
  14. Use of atherectomy or other atheroablative (e.g. cryoplasty) devices at the time of index procedure.
  15. Restenotic lesion that had previously been treated by atherectomy, laser or cryoplasty within 3 months of the index procedure.
  16. Subject has tissue loss, defined as Rutherford-Becker classification category 5 or 6.
  17. Coronary intervention within 7 days prior to or planned within 30 days after the treatment of the target lesion.
  18. Stroke within the previous 90 days.
  19. 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.
  20. Receiving dialysis or immunosuppressant therapy within the previous 30 days.
  21. Known or suspected active infection at the time of the procedure.
  22. History of neutropenia, coagulopathy, or thrombocytopenia.
  23. Known bleeding or hypercoagulability disorder or significant anemia (Hb<8.0) that cannot be corrected.
  24. Platelet count <80,000/μL
  25. International normalized ratio (INR) > 1.5
  26. GFR <30 ml/min by Cockroft-Gault.
  27. Subject requires general anesthesia for the procedure.
  28. Subject has a co-morbid illness that may result in a life expectancy of less than 1 year
  29. Planned use of a drug coated balloon (DCB) during the index procedure.
  30. 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;
  31. Subject is participating in any investigational study that has not yet reached its primary endpoint.

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): NCT03775226


Contacts
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Contact: Gali Vino 972-3-767-9000 ext 3258 galiv@MEDINOL.COM
Contact: Hila Ezra Altshuler 972-3-767-9000 ext 3369 hilae@MEDINOL.COM

Locations
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Israel
Hadassah Medical Center Recruiting
Jerusalem, Israel
Contact: Ron Carmeli, MD       ronc@hadassah.org.il   
Rabin Medical Center Recruiting
Petah tikva, Israel
Contact: Eli Atar, MD         
Sourasky Medical Center Recruiting
Tel Aviv, Israel
Contact: Isaack Kori, MD       isaack@tlvmc.gov.il   
Sponsors and Collaborators
Medinol Ltd.
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Responsible Party: Medinol Ltd.
ClinicalTrials.gov Identifier: NCT03775226    
Other Study ID Numbers: SFA-Israel-001
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: August 14, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases