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The Lumen Study: Comparing Devices for Patients With Symptomatic Femoro-popliteal Chronic Total Occlusion (CTO)

NCT02145299 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2016-11-04

Study results available
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Summary

This is a prospective, multicenter, randomized, single-blind study enrolling up to 75 subjects at up to 5 sites in the US. Eligible subjects with symptomatic femoro-popliteal CTO will be randomized 2:1 to treatment with the TruePath™ CTO Device (Intervention) or the CROSSER™ CTO device (Control). All patients will receive standard anticoagulation per hospital protocol and antiplatelet therapy with aspirin and clopidogrel.

Conditions

  • Symptomatic Femoro-popliteal Chronic Total Occlusion

Interventions

DEVICE

TruePath CTO Device

The TruePath CTO Device is composed of a 0.018" guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions.

DEVICE

CROSSER CTO Device

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Yale University

    lead OTHER

Principal Investigators

  • Carlos Mena, MD · Yale University

  • Alexandra Lansky, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2015-03-31
Completion
2015-06-30

Countries

  • United States

Study Locations

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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 NCT02145299 on ClinicalTrials.gov