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CELLO - CLiRpath® Excimer Laser System to Enlarge Lumen Openings

NCT00595959 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2011-07-12

Study results available
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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

Interventions

DEVICE

CLiRpath Photoablation System

Use of CLiRpath Laser Catheter to improve vessel lumen diameter.

Sponsors & Collaborators

  • Spectranetics Corporation

    lead INDUSTRY

Principal Investigators

  • Thomas M Rasmussen · Spectranetics Corp.

  • Rajesh Dave, MD · Pinnacle Health Hospital, Central Pennsylvania Research Foundation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2007-04-30
Completion
2008-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00595959 on ClinicalTrials.gov