CELLO - CLiRpath® Excimer Laser System to Enlarge Lumen Openings

Phase 3

Completed

Conditions: Peripheral Artery Disease

Interventions: Device: CLiRpath Photoablation System

Registration Number: NCT00595959

Lead Sponsor: Spectranetics Corporation

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 65

Inclusion Criteria

General Inclusion Criteria

Peripheral vascular disease Rutherford Classification 1, 2, or 3;
Eligible for revascularization of native vessel (PTA or bypass);
Willing and able to comply with the specified evaluations during hospitalization and all required follow-up examinations;
Written informed consent given before execution of study procedures; and
Age > 18 and ≤ 85 years.

Angiographic Inclusion Criteria

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.
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.
At least 1.0 cm of visible SFA stump beyond the origin of the profunda artery.
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.
Patency (< 50% DS) of at least one (1) infrapopliteal artery in continuity with the native femoropopliteal artery.

Exclusion Criteria

General Exclusion Criteria

Contraindication to intravenous contrast material, heparin, aspirin or other medications required for a percutaneous interventional procedure;
Known bleeding or hyper-coagulation disorder;
Serum creatinine > 2.0 mg/dL;
Uncompensated congestive heart failure;
Current enrollment in any investigational study wherein patient participation has not been completed;
Prior enrollment in this study;
Suspected or confirmed pregnancy;
Any patient, who in the opinion of the investigator, would not be a good candidate for enrollment;
Myocardial infarction within 60 days; and
CVA/TIA within 60 days. Angiographic Exclusion Criteria
Subintimal guidewire placement following pilot channel creation through a stenosis or occlusion with any excimer laser catheter, as visualized with IVUS;
Calcification likely to prevent the passage of the excimer laser catheter or CLiRpath® Photoablation Atherectomy system;
Ipsilateral and/or contralateral iliac stenosis >/= 50% DS that is not treated prior to enrollment in this study;
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;
Iliac treatment prior to enrollment where a perforation occurred requiring a covered stent, blood transfusion, or surgery for treatment of the perforation;
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;
Lesions proximal and distal to the treatment site that are >/= 50% DS at time of enrollment;
Contralateral leg disease that requires treatment within the next 30 days and prior to completion of the 30 day follow-up;
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;
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
Perforation or dissection of grade "C" or greater seen during or after the creation of the pilot channel.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laser Treatment	CLiRpath Photoablation System	CLiRpath Photoablation Atherectomy System

Primary Outcome Measures

Name	Time	Method
Laser Success	Measured at time of procedure	The primary efficacy endpoint is laser success, defined as achieving \>/= 20% average reduction in the percent (%) diameter stenosis, post-laser and prior to adjunctive therapy, based on angiographic core laboratory assessment.
Major Adverse Events	From discharge through the 6 month follow-up	The primary safety endpoint is the occurrence of major adverse events defined as clinical perforation, major dissection requiring surgery, major amputation, cerebrovascular accidents (CVA), myocardial infarction, and death.

Secondary Outcome Measures

Name	Time	Method
Procedural Success	measured at time of procedure	Acute procedural success, defined as achievement of \</= 30% final residual stenosis, as visually assessed by angiography after all adjunctive treatment(s) deemed necessary by the treating physician. Measures % of patients who achieved a final residual stenosis of \</=30%.
Minimum and Maximum Lumen Diameters	measured at time of procedure	Minimum and maximum lumen diameters immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by Intravascular Ultrasound (IVUS).
Clinical Success	measured post discharge thorugh 12 Months follow-up	Clinical success, defined as primary patency (≤ 50% stenosis at the treatment site), as assessed by duplex Doppler ultrasound at 30 days, six (6) months and 12 months post-procedure
Assisted Primary Patency	Through 12 Months	Incidence of freedom from assisted primary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a stenosis (patent vessel) at the treatment site to prevent reocclusion
Assisted Secondary Patency	Through 12 Month	Incidence of freedom from assisted secondary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a reocclusion (non-patent vessel) at the treatment site
Patients With >50% Stenosis Measured by Duplex Ultrasound	Through 12 Month	Percentage of patients with \>50% stenosis at each follow-up (30 days, six months, and 12 months post-procedure).
Rutherford Classification	Through 12 Months	Rutherford Classification at 30 days, six (6) and 12 months post-procedure. Physician assessed based on ankle pressures and treadmill testing. Rutherford scale: 0=best, 6=worst
Adverse Events	Through 12 Months	Adverse events during procedure and prior to release from the hospital, at 30 days, six (6) months, and 12 months post-procedure.
Volumetric Plaque Reduction	measured at time of procedure	Volumetric plaque reduction immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by IVUS. Actual volume of plaque present is presented for each measurement point.