CELLO - CLiRpath® Excimer Laser System to Enlarge Lumen Openings

Peripheral Artery Disease Clinical Trial

— CELLO  

Official title:

CLiRpath® Excimer Laser System to Enlarge Lumen Openings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00595959
• Other study ID #: 9000-0001-03 CELLO
• Status: Completed
• Phase: Phase 3
• First received: January 4, 2008
• Last updated: June 13, 2011
• Start date: November 2006
• Est. completion date: April 2008

Study information

• Verified date: June 2011
• Source: Spectranetics Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 2008
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Device:
• CLiRpath Photoablation System
Use of CLiRpath Laser Catheter to improve vessel lumen diameter.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Spectranetics Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	Procedural Success	Acute procedural success, defined as achievement of	measured at time of procedure	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No