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An Evaluation of a Clinical Algorithm With Turbo-Power Following Treatment of Specific Morphologies

NCT02921542 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 57

Last updated 2019-07-18

No results posted yet for this study

Summary

To evaluate vessel lumen quality (gain) and patient outcomes based on treatment with a predetermined laser treatment protocol in patients presenting with varying lesion types or morphologies: homogenous (plaques with a uniform texture-smooth and regular), heterogeneous (plaques with non-uniform texture-smooth and irregular surface), calcific (consisting of calcium) and restenotic (reoccurring narrowing of the vessel following prior treatment) associated with peripheral arterial disease (PAD).

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Laser Atherectomy

The Turbo-Power is laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents with adjunctive percutaneous transluminal angioplasty (PTA).

Sponsors & Collaborators

  • Spectranetics Corporation

    lead INDUSTRY

Principal Investigators

  • George Adams, MD · UNC Hospitals - REX

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-15
Primary Completion
2018-05-15
Completion
2019-05-01

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 NCT02921542 on ClinicalTrials.gov