CELLO - CLiRpath® Excimer Laser System to Enlarge Lumen Openings (CELLO)

CLiRpath® Excimer Laser System to Enlarge Lumen Openings

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: CLiRpath Photoablation System

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laser Treatment; CLiRpath Photoablation Atherectomy System	Device: CLiRpath Photoablation System; Use of CLiRpath Laser Catheter to improve vessel lumen diameter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laser Success	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.	Measured at time of procedure
Major Adverse Events	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.	From discharge through the 6 month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Success	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%.	measured at time of procedure
Minimum and Maximum Lumen Diameters	Minimum and maximum lumen diameters immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by Intravascular Ultrasound (IVUS).	measured at time of procedure
Clinical Success	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	measured post discharge thorugh 12 Months follow-up
Assisted Primary Patency	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	Through 12 Months
Assisted Secondary Patency	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	Through 12 Month
Patients With >50% Stenosis Measured by Duplex Ultrasound	Percentage of patients with >50% stenosis at each follow-up (30 days, six months, and 12 months post-procedure).	Through 12 Month
Rutherford Classification	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	Through 12 Months
Adverse Events	Adverse events during procedure and prior to release from the hospital, at 30 days, six (6) months, and 12 months post-procedure.	Through 12 Months
Volumetric Plaque Reduction	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.	measured at time of procedure

Collaborators and Investigators

• Sponsor: Spectranetics Corporation
• Investigators: Study Director: Thomas M Rasmussen, Spectranetics Corp.; Principal Investigator: Rajesh Dave, MD, Pinnacle Health Hospital, Central Pennsylvania Research Foundation

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): April 1, 2007
• Study Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: January 4, 2008
• First Submitted That Met QC Criteria: January 4, 2008
• First Posted (Estimate): January 16, 2008

Study Record Updates

• Last Update Posted (Estimate): July 12, 2011
• Last Update Submitted That Met QC Criteria: June 13, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: 9000-0001-03 CELLO