CELLO - CLiRpath® Excimer Laser System to Enlarge Lumen Openings

NCT00595959 | Completed Phase 3 Results DMC

• 1 other identifier: 9000-0001-03 CELLO
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (9)

• Procedural Success

  measured at time of procedure

• Minimum and Maximum Lumen Diameters

  measured at time of procedure

• Clinical Success

  measured post discharge thorugh 12 Months follow-up

• Assisted Primary Patency

  Through 12 Months

• Assisted Secondary Patency

  Through 12 Month

Study Arms (1)

Laser Treatment

EXPERIMENTAL

CLiRpath Photoablation Atherectomy System

Device: CLiRpath Photoablation System

Interventions

CLiRpath Photoablation System DEVICE

Use of CLiRpath Laser Catheter to improve vessel lumen diameter.

Laser Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Peripheral vascular disease Rutherford Classification 1, 2, or 3;
• Eligible for revascularization of native vessel (PTA or bypass);
• Willing and able to comply with the specified evaluations during hospitalization and all required follow-up examinations;
• Written informed consent given before execution of study procedures; and
• Age \> 18 and ≤ 85 years.
• 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.
• 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.
• At least 1.0 cm of visible SFA stump beyond the origin of the profunda artery.
• 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.
• Patency (\< 50% DS) of at least one (1) infrapopliteal artery in continuity with the native femoropopliteal artery.

You may not qualify if:

• Contraindication to intravenous contrast material, heparin, aspirin or other medications required for a percutaneous interventional procedure;
• Known bleeding or hyper-coagulation disorder;
• Serum creatinine \> 2.0 mg/dL;
• Uncompensated congestive heart failure;
• Current enrollment in any investigational study wherein patient participation has not been completed;
• Prior enrollment in this study;
• Suspected or confirmed pregnancy;
• Any patient, who in the opinion of the investigator, would not be a good candidate for enrollment;
• Myocardial infarction within 60 days; and
• Subintimal guidewire placement following pilot channel creation through a stenosis or occlusion with any excimer laser catheter, as visualized with IVUS;
• Calcification likely to prevent the passage of the excimer laser catheter or CLiRpath® Photoablation Atherectomy system;
• Ipsilateral and/or contralateral iliac stenosis \>/= 50% DS that is not treated prior to enrollment in this study;
• 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;
• Iliac treatment prior to enrollment where a perforation occurred requiring a covered stent, blood transfusion, or surgery for treatment of the perforation;
• 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;

Sponsors & Collaborators

• Spectranetics Corporation: lead

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Limitations and Caveats

Non-randomized study

Results Point of Contact

• Title: Thomas M. Rasmussen V.P. Clinical Affairs
• Organization: Spectranetics Inc

thomas.rasmussen@spnc.com

719-447-2471

Study Officials

• Thomas M Rasmussen

  Spectranetics Corp.

  STUDY DIRECTOR

• Rajesh Dave, MD

  Pinnacle Health Hospital, Central Pennsylvania Research Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 16, 2008
• Study Start: November 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2008
• Last Updated: July 12, 2011
• Results First Posted: June 19, 2009

Record last verified: 2011-06