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The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients with Symptomatic Peripheral Vascular Disease from Stenosis or Occlusion of the Femoropopliteal Artery

NARECRUITING

To evaluate the safety and performance of the EVSS in patients with symptomatic peripheral vascular disease from stenosis or occlusion of the femoropopliteal artery.

Study details:

The EFEMORAL I study is a prospective, single-arm, open-labeled, multi-center, clinical investigation enrolling patients with arterial diameter of ≥5. 5 mm and ≤6. 5 mm and lesion length ≤90 mm receiving a single EVSS.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Symptomatic peripheral vascular occlusive disease (Rutherford-Becker Clinical Category 2-4)
  2. Patient with life expectancy >36 months
  3. Females of childbearing potential must have negative pregnancy test
  4. Patient is able to provide informed consent
  5. Patient agrees to undergo all protocol-required follow-up examinations and requirements at the investigational site.
  6. Patient must be able to take antiplatelet and/or anticoagulant agents as prescribed
  7. Single de novo native disease segment of the superficial femoral artery (SFA) or P1 popliteal segment
  8. Reference vessel diameter ≥5.5 mm and ≤6.5 mm
  9. Target lesion length ≤90 mm
  10. Target lesion with ≥50% DS
  11. Inflow artery and popliteal artery free from flow-limiting lesion (DS <50%)

Exclusion criteria

  1. Hemoglobin <9.0 g/dL
  2. WBC <3,000 cells/mm3
  3. Platelet count <80,000 cells/mm3 or >700,000 cells/mm3
  4. Acute or chronic renal dysfunction with creatinine >2.5 mg/dl (176 µmol/L)
  5. Severe liver impairment as defined by total bilirubin ≥3 mg/dl or two times increase over the normal level of SGOT or SGPT
  6. A known hypersensitivity or contraindication to aspirin, heparin, bivalirudin, ticagrelor or sirolimus, or with contrast sensitivity for which the patient cannot be adequately pre-medicated
  7. Patient requires a planned procedure that would necessitate discontinuation of antiplatelet therapy
  8. Patient is unable to walk
  9. Patient has undergone a percutaneous vascular intervention <30 days prior to the planned index procedure
  10. Patient is maintained on chronic hemodialysis
  11. Patient has uncontrolled diabetes mellitus (HbA1c ≥7.0%).
  12. Patient has had a myocardial infarction within the previous 30 days of the planned index procedure
  13. Patient has had a stroke within the previous 30 days of the planned index procedure and/or has deficits from a prior stroke that limits the patient's ability to walk
  14. Patient has unstable angina defined as rest angina with ECG changes
  15. Patient has a local groin or acute systemic infection that has not been treated successfully or is currently under treatment
  16. Patient has acute thrombophlebitis, deep vein thrombosis or chronic venous insufficiency in either extremity
  17. Patient has other medical illnesses (e.g., cancer, congestive cardiomyopathy, etc.) that may cause the patient to be non-compliant with protocol requirements, confound the data interpretation or will prevent completion of all required follow up assessments through 36 months
  18. Patient is currently participating in an investigational drug, biologic, or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
  19. Patient has ischemic or neuropathic ulcers on either foot
  20. Patient has undergone minor or major amputation of either lower extremity
  21. Patient is part of a vulnerable population who, in the judgment of the Investigator, is unable to give informed consent
  22. Target extremity with an angiographically significant (>50% DS) lesion located distal to the target lesion that requires treatment at the time of the index procedure or by a staged procedure
  23. Acute arterial ischemia of the target extremity
  24. Target extremity has been previously treated with open surgical revascularization (bypass or endarterectomy)
  25. Target vessel has been previously treated with stent, laser, atherectomy, surgical bypass, or endarterectomy
  26. Total occlusion (100% DS) of the ipsilateral inflow artery
  27. Angiographic evidence of thrombus in the target vessel
  28. The target lesion requires treatment with a device other than percutaneous transluminal balloon angioplasty (PTA) [e.g., orbital atherectomy, directional atherectomy, excimer laser, rotational atherectomy, cryoplasty, etc.]
  29. Target lesion is within or adjacent to an aneurysm
  30. Patient has angiographic evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion or from crossing or pre-dilating the target lesion
  31. Target lesion has moderate-to-severe calcification
  32. Target lesion with > 30% residual stenosis following pre-dilatation

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    NA

trial

Study ID

NCT04584632

Intervention or treatment

DEVICE: Efemoral Vascular Scaffold System (EVSS)

Conditions

  • Peripheral Arterial Disease
  • Vascular Diseases
  • Stenosis
  • Femoropopliteal Stenosis

  • Condition: Peripheral Arterial Disease, Vascular Diseases and more

  • DEVICE: Efemoral Vascular Scaffold System (EVSS)

  • Sydney, Australia

  • Sponsor: Efemoral Medical, Inc.

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Prince Of Wales Hospital

Select from list below to view details:

  • Prince Of Wales Hospital

    Sydney, Australia

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Who is running the clinical trial?

EMI

Efemoral Medical, Inc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: EVSS
  • Efemoral Vascular Scaffold System (EVSS)
Device: Efemoral Vascular Scaffold System (EVSS)

    What is the study measuring?

    Primary Outcome

    MeasureDescriptionTime Frame
    Major Adverse Event (MAE)Not Specified30 days
    Freedom from Binary RestenosisNot Specified12 months

    Secondary Outcome

    MeasureDescriptionTime Frame
    Device SuccessAchievement of successful delivery and deployment of the study device(s) at the intended target lesionDay 0
    Primary patency rateNot Specified1, 6, 12, 24 and 36 months
    Binary restenosis rateNot Specified1, 6, 12, 24 and 36 months
    Target lesion revascularization (TLR)Not Specified1, 6, 12, 24 and 36 months
    Ipsilateral extremity revascularization (IER)Not Specified1, 6, 12, 24 and 36 months
    Number of patients with Scaffold thrombosisNot Specifiedthrough 1 month
    Number of patients with scaffold occlusionNot Specified6, 12, 24 and 36 months
    Rate of Major Adverse Limb EventsNot Specifiedthrough 36 months
    Ankle-brachial index (ABI) of target extremityNot Specified1, 6, 12, 24 and 36 months
    Limb salvage of target extremityNot Specified1, 6, 12, 24 and 36 months
    Rutherford-Becker Clinical Category for the target extremityNot Specified1, 6, 12, 24 and 36 months
    Walking impairment as assessed by Walking Impairment Questionnaire (WIQ)Not Specified1, 6, 12, 24 and 36 months
    Clinical SuccessAttainment of a final residual stenosis of \<30% using the study device(s) and/or any adjunctive device at the intended target lesion without complicationsUp to 2 days after procedure
    Technical SuccessAttainment of a final residual stenosis of \<30% at the intended target lesion(Day 0
    Are you running this trial?If you're a clinic or sponsor, you can claim this study.
    Claim this trial

    References

    Clinical Trials Gov: The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients with Symptomatic Peripheral Vascular Disease from Stenosis or Occlusion of the Femoropopliteal Artery

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