CELLO - CLiRpath® Excimer Laser System to Enlarge Lumen Openings

This study has been completed.
Sponsor:
Information provided by:
Spectranetics Corporation
ClinicalTrials.gov Identifier:
NCT00595959
First received: January 4, 2008
Last updated: June 13, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Peripheral Artery Disease
Device: CLiRpath Photoablation System
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CLiRpath® Excimer Laser System to Enlarge Lumen Openings

Resource links provided by NLM:


Further study details as provided by Spectranetics Corporation:

Primary Outcome Measures:
  • Laser Success [ Time Frame: Measured at time of procedure ] [ Designated as safety issue: No ]
    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 [ Time Frame: From discharge through the 6 month follow-up ] [ Designated as safety issue: Yes ]
    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:
  • Procedural Success [ Time Frame: measured at time of procedure ] [ Designated as safety issue: No ]
    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 [ Time Frame: measured at time of procedure ] [ Designated as safety issue: No ]
    Minimum and maximum lumen diameters immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by Intravascular Ultrasound (IVUS).

  • Clinical Success [ Time Frame: measured post discharge thorugh 12 Months follow-up ] [ Designated as safety issue: No ]
    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 [ Time Frame: Through 12 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Through 12 Month ] [ Designated as safety issue: No ]
    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 [ Time Frame: Through 12 Month ] [ Designated as safety issue: No ]
    Percentage of patients with >50% stenosis at each follow-up (30 days, six months, and 12 months post-procedure).

  • Rutherford Classification [ Time Frame: Through 12 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Through 12 Months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: measured at time of procedure ] [ Designated as safety issue: No ]
    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.


Enrollment: 65
Study Start Date: November 2006
Study Completion Date: April 2008
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laser Treatment
CLiRpath Photoablation Atherectomy System
Device: CLiRpath Photoablation System
Use of CLiRpath Laser Catheter to improve vessel lumen diameter.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

    -

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00595959

Sponsors and Collaborators
Spectranetics Corporation
Investigators
Study Director: Thomas M Rasmussen Spectranetics Corp.
Principal Investigator: Rajesh Dave, MD Pinnacle Health Hospital, Central Pennsylvania Research Foundation
  More Information

No publications provided

Responsible Party: Rajesh M. Dave, M.D., Pinnacle Health Hospital, Central Pennsylvania Research Foundation
ClinicalTrials.gov Identifier: NCT00595959     History of Changes
Other Study ID Numbers: 9000-0001-03 CELLO
Study First Received: January 4, 2008
Results First Received: February 23, 2009
Last Updated: June 13, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014