A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL)

STUDY OVERVIEW

This is a prospective, multicenter, single-arm study sponsored by ReFlow Medical Inc. designed to evaluate the safety and efficacy of the Temporary Bare Spur Stent System (Spur Stent System).

STUDY GOALS

The goal of this study is to evaluate the safety and efficacy of the Temporary Bare Spur Stent System (Spur Stent System) in a prospective, multicenter, single-arm trial.

LOCATION

El Paso, Texas: El Paso Cardiology Associates, Laiq Raja, M.D.

INCLUSION CRITERIA

  • General

    • Must provide informed consent.

    • Life expectancy >1 year.

    • Age ≥18 years.

    • Chronic limb ischemia symptoms (Rutherford class 4-5) not manageable by conservative therapy.

  • Angiographic

    • Lesions in infrapopliteal vessels treatable via true lumen.

    • Iliac, SFA, and popliteal inflow lesions treatable during or before procedure.

    • Target vessel reconstitutes at or above ankle with inline flow to foot.

    • Target lesion in tibial arteries, ≤210mm in length, and appropriate vessel size (2.5-4.5 mm).

    • Successful pre-dilation of target lesion.

    • Only one limb and one contiguous vessel can be treated.

exclusion criteria

  • General

    • Unlikely to comply with 1-year study duration.

    • Pregnancy or planning to become pregnant.

    • Active uncontrolled systemic infection.

    • Proximal osteomyelitis.

    • Wounds above the ankle.

    • Planned major amputation.

    • Recent MI or stroke (<90 days).

    • Symptomatic acute heart failure (NYHA class III or greater).

    • Impaired renal function (eGFR ≤25 mL/min) or on dialysis.

    • Inability to tolerate dual antiplatelet/anticoagulation therapy.

    • Allergies to relevant drugs or contrast media.

    • Enrolled in another conflicting trial.

    • Allergy to nitinol or nickel.

    • Prior bypass surgery of target vessels.

  • Angiographic

    • Lesions within or associated with aneurysms.

    • Fractured or compromised stents in target/inflow vessels.

    • In-stent restenosis in target vessel.

    • Prior treatment of inflow/target vessels within 7-90 days.

    • Thrombus in target limb.

    • Severe calcification not amenable to PTA.

    • Type D dissections or greater.

    • Significant stenosis or unsuccessful treatment of inflow arteries.

    • Distance to lesion exceeds 135 cm working length of stent catheter.

For more information, visit ClinicalTrials.gov.