CELLO - CLiRpath® Excimer Laser System to Enlarge Lumen Openings
Condition: Peripheral Artery Disease
MeSH terms: Peripheral Arterial Disease
Intervention: CLiRpath Photoablation System
Intervention description: Use of CLiRpath Laser Catheter to improve vessel lumen diameter.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and efficacy of the CLiRpath®
      Photoablation Atherectomy System consisting of the Bias Sheath guiding catheter, in
      combination with the available CLiRpath® Excimer Laser Catheters ≤ 2.0 mm, to create larger
      lumens for treatment within the superficial femoral and popliteal arteries above the knee.
    

Eligibility criteria:

        Inclusion Criteria:

        General Inclusion Criteria

          1. Peripheral vascular disease Rutherford Classification 1, 2, or 3;

          2. Eligible for revascularization of native vessel (PTA or bypass);

          3. Willing and able to comply with the specified evaluations during hospitalization and
             all required follow-up examinations;

          4. Written informed consent given before execution of study procedures; and

          5. Age > 18 and ≤ 85 years.

        Angiographic Inclusion Criteria

          1. Reference vessel diameter >/= 4.0 mm and ≤ 7.0 mm as determined by physician visual
             angiographic assessment of the most normally appearing vessel segment within 10 mm
             proximal AND 10 mm distal to the target segment.

          2. Stenosis within the SFA and/or popliteal artery above the knee of >/= 70% and </= 100%
             DS (occlusion), as determined by visual angiographic assessment by the investigator at
             the time of the procedure and documented by angiography in at least two (2) orthogonal
             views.

          3. At least 1.0 cm of visible SFA stump beyond the origin of the profunda artery.

          4. Total lesion length >/= 1.0 cm and ≤ 15.0 cm as determined by visual angiographic
             assessment at the time of the procedure, separate multiple lesions can be combined as
             two separate treatment areas as long as the sum total of all lesion lengths and/or
             treatment areas does not exceed 1.0 cm to 15.0 cm.

          5. Patency (< 50% DS) of at least one (1) infrapopliteal artery in continuity with the
             native femoropopliteal artery.

             -

        Exclusion Criteria:

        General Exclusion Criteria

          1. Contraindication to intravenous contrast material, heparin, aspirin or other
             medications required for a percutaneous interventional procedure;

          2. Known bleeding or hyper-coagulation disorder;

          3. Serum creatinine > 2.0 mg/dL;

          4. Uncompensated congestive heart failure;

          5. Current enrollment in any investigational study wherein patient participation has not
             been completed;

          6. Prior enrollment in this study;

          7. Suspected or confirmed pregnancy;

          8. Any patient, who in the opinion of the investigator, would not be a good candidate for
             enrollment;

          9. Myocardial infarction within 60 days; and

         10. CVA/TIA within 60 days. Angiographic Exclusion Criteria

        1.

          1. Subintimal guidewire placement following pilot channel creation through a stenosis or
             occlusion with any excimer laser catheter, as visualized with IVUS;

          2. Calcification likely to prevent the passage of the excimer laser catheter or CLiRpath®
             Photoablation Atherectomy system;

          3. Ipsilateral and/or contralateral iliac stenosis >/= 50% DS that is not treated prior
             to enrollment in this study;

          4. Ipsilateral and/or contralateral iliac treatment of a stenosis prior to enrollment
             with final residual stenosis >/= 30%, as determined in at least two (2) orthogonal
             views and documented by angiography;

          5. Iliac treatment prior to enrollment where a perforation occurred requiring a covered
             stent, blood transfusion, or surgery for treatment of the perforation;

          6. Identification of any lesion above the knee and/or below the knee in the treated leg
             (ipsilateral) that will require preplanned or predicted treatment within six (6)
             months after enrollment and prior to the completion of the six (6) month follow-up,
             including the iliac artery, the common femoral artery, the peroneal, anterior tibial,
             or posterior tibial arteries, or any area from the iliacs to the foot outside of the
             treatment area;

          7. Lesions proximal and distal to the treatment site that are >/= 50% DS at time of
             enrollment;

          8. Contralateral leg disease that requires treatment within the next 30 days and prior to
             completion of the 30 day follow-up;

          9. Cardiovascular surgical or cardiovascular interventional procedures (including, but
             not limited to, aortic, renal, cardiac, carotid, femoro-popliteal, and below the knee)
             within 30 days prior to enrollment in this study;

         10. Planned or predicted cardiovascular surgical or interventional procedures outside of
             the ipsilateral leg (including, but not limited to aortic, renal, cardiac, carotid,
             contralateral femoro-popliteal, and contralateral below the knee) within 30 days after
             entry into this study, and prior to completion of the 30-day follow-up; and

         11. Perforation or dissection of grade "C" or greater seen during or after the creation of
             the pilot channel.