Clinical trial NCT00595959: CELLO - CLiRpath® Excimer Laser System to Enlarge Lumen Openings
Official title: CLiRpath® Excimer Laser System to Enlarge Lumen Openings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Artery Disease
Lead sponsor: Spectranetics Corporation
Sponsor class: INDUSTRY
First posted: 2008-01-16
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

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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.

Primary outcomes:
measure: Laser Success
timeFrame: Measured at time of procedure
measure: Major Adverse Events
timeFrame: From discharge through the 6 month follow-up
Secondary outcomes:
measure: Procedural Success
timeFrame: measured at time of procedure
measure: Minimum and Maximum Lumen Diameters
timeFrame: measured at time of procedure
measure: Clinical Success
timeFrame: measured post discharge thorugh 12 Months follow-up
measure: Assisted Primary Patency
timeFrame: Through 12 Months
measure: Assisted Secondary Patency
timeFrame: Through 12 Month
measure: Patients With >50% Stenosis Measured by Duplex Ultrasound
timeFrame: Through 12 Month
measure: Rutherford Classification
timeFrame: Through 12 Months
measure: Adverse Events
timeFrame: Through 12 Months
measure: Volumetric Plaque Reduction
timeFrame: measured at time of procedure
Other outcomes:
Locations:
Study officials:
affiliation: Spectranetics Corp.
name: Thomas M Rasmussen
role: STUDY_DIRECTOR
affiliation: Pinnacle Health Hospital, Central Pennsylvania Research Foundation
name: Rajesh Dave, MD
role: PRINCIPAL_INVESTIGATOR
References: