CELLO - CLiRpath® Excimer Laser System to Enlarge Lumen Openings (CELLO)
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|ClinicalTrials.gov Identifier: NCT00595959|
Recruitment Status : Completed
First Posted : January 16, 2008
Results First Posted : June 19, 2009
Last Update Posted : July 12, 2011
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Artery Disease||Device: CLiRpath Photoablation System||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CLiRpath® Excimer Laser System to Enlarge Lumen Openings|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||April 2007|
|Actual Study Completion Date :||April 2008|
Experimental: Laser Treatment
CLiRpath Photoablation Atherectomy System
Device: CLiRpath Photoablation System
Use of CLiRpath Laser Catheter to improve vessel lumen diameter.
- Laser Success [ Time Frame: Measured at time of procedure ]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 ]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.
- Procedural Success [ Time Frame: measured at time of procedure ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00595959
|Study Director:||Thomas M Rasmussen||Spectranetics Corp.|
|Principal Investigator:||Rajesh Dave, MD||Pinnacle Health Hospital, Central Pennsylvania Research Foundation|