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OptiCal COherence ToMography ABoard InformiNg AtherEctomy

NCT01775410 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2021-04-21

Study results available
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Summary

This is a prospective, multi-center, non-randomized single arm feasibility trial of the Wolverine OCT guided atherectomy system.The trial will enroll up to 50 subjects diagnosed with peripheral vascular disease of the lower extremities.The primary disease must be located in reference vessel diameters ≥ 2.5 mm which is significant enough to cause moderate to severe symptoms and warrant vascular intervention.

Conditions

  • Atherectomy in Diseased Lower Extremity Arteries

Interventions

DEVICE

Wolverine System to perform atherectomy

Sponsors & Collaborators

  • Avinger, Inc.

    lead INDUSTRY

Principal Investigators

  • John B Simpson, MD · Avinger, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2013-08-31
Completion
2013-08-27

Countries

  • Colombia

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 NCT01775410 on ClinicalTrials.gov