The Lumen Study: Comparing Devices for Patients With Symptomatic Femoro-popliteal Chronic Total Occlusion (CTO)
Condition: Symptomatic Femoro-popliteal Chronic Total Occlusion
Intervention: TruePath CTO Device; CROSSER CTO Device
Intervention description: The TruePath CTO Device is composed of a 0.018" guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      This is a prospective, multicenter, randomized, single-blind study enrolling up to 75
      subjects at up to 5 sites in the US. Eligible subjects with symptomatic femoro-popliteal CTO
      will be randomized 2:1 to treatment with the TruePath™ CTO Device (Intervention) or the
      CROSSER™ CTO device (Control). All patients will receive standard anticoagulation per
      hospital protocol and antiplatelet therapy with aspirin and clopidogrel.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical Inclusion Criteria

          -  Male or non-pregnant female ≥18 years of age;

          -  Rutherford Clinical Category 2-5

          -  Patients is willing to provide informed consent and comply with the required follow-up
             visits, testing schedule, and medication regimen

          -  Angiographic Lesion Inclusion Criteria

          -  Length ≤35 cm

          -  The lesion is a single lesion or composite of multiple lesions within the 35 cm
             segment

          -  100% stenosis by visual estimate

          -  Previously documented conventional percutaneous procedure or a concurrent failed
             attempt to cross the CTO using conventional guidewire techniques

          -  Ability to visualize target artery distal to the lesion (via collateral circulation)

          -  Target lesion located in the superficial femoral/proximal popliteal arteries, with
             lesion location starting ≥1cm below the common femoral bifurcation

          -  De novo lesion or restenotic lesion >30 days from any prior endovascular intervention

          -  Target vessel diameter ≥4 and ≤7 mm and able to be treated with PTA and or a stent

          -  A patent inflow artery free from significant lesions (≥50% stenosis) as confirmed by
             angiography. Treatment of the target lesion may be performed after successful
             treatment of existing inflow artery lesions at the time of the index procedure. [NOTE:
             Successful inflow artery treatment is defined as attainment of residual diameter
             stenosis ≤50% without death or major vascular complication.]

          -  At least one patent outflow artery free from significant lesion (≥50% stenosis) as
             confirmed by angiography (treatment of outflow disease is permitted)

        Exclusion Criteria:

          -  Pregnant or nursing subjects and those who plan pregnancy in the period up to 3 months
             following index procedure. Female subjects of child-bearing potential must have a
             negative pregnancy test done prior to the index procedure.

          -  Rutherford Class 0, 1 or 6

          -  History of hemorrhagic stroke within 3 months

          -  Renal failure or chronic kidney disease with MDRD GFR ≤ 30 ml/min per 1.73m2 (or serum
             creatinine ≥2.5 mg/L within 30 days of index procedure or treated with dialysis)

          -  Previous or planned surgical or interventional procedure to the target limb within 2
             weeks before (aside from conventional percutaneous procedure during the current
             hospitalization) or within 30 days after the index procedure

          -  Prior vascular surgery of the index limb, with the exception of common femoral patch
             angioplasty remote from the target lesion

          -  Planned use of adjunctive primary treatment modalities (e.g., laser, atherectomy,
             cryoplasty, scoring/cutting balloon, or other)

          -  Inability to take required study medications or an allergy to contrast that cannot be
             controlled with medication

          -  Life expectancy of <1 years

          -  Patient is currently participating in an investigational drug or device study or
             previously enrolled in this study Subject enrollment and treatment