CELLO - CLiRpath® Excimer Laser System to Enlarge Lumen Openings

NCT ID: NCT00595959

Last Updated: 2011-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2008-04-30

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.

Conditions

Peripheral Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laser Treatment

CLiRpath Photoablation Atherectomy System

Group Type: EXPERIMENTAL

CLiRpath Photoablation System

Intervention Type: DEVICE

Use of CLiRpath Laser Catheter to improve vessel lumen diameter.

Interventions

CLiRpath Photoablation System

Use of CLiRpath Laser Catheter to improve vessel lumen diameter.

Intervention Type: DEVICE

Eligibility Criteria

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.

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

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spectranetics Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Pinnacle Health Hospital, Central Pennsylvania Research Foundation

Principal Investigators

Thomas M Rasmussen

Role: STUDY_DIRECTOR

Spectranetics Corp.

Rajesh Dave, MD

Role: PRINCIPAL_INVESTIGATOR

Pinnacle Health Hospital, Central Pennsylvania Research Foundation

Other Identifiers

9000-0001-03 CELLO

Identifier Type: -

Identifier Source: org_study_id