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ATHERO: Advanced Technology Halting Early Re-Stenosis and Occlusion

NCT00407940 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-06-13

No results posted yet for this study

Summary

The rise of minimal access surgery has heralded the approval of a number of endovascular devices with similar indications. This is particularly true for the treatment of lower extremity ischemia. Comparable devices are selected for patient use somewhat arbitrarily, often dependent on industry influence. An unmet need is NON-industry sponsored prospective trials COMPARING devices head-to-head so that endovascular surgeons can even contemplate evidence-based device selection. At present, we seek to compare two new high-technology devices that are indicated to treat lower extremity arterial stenoses associated with claudication.

Conditions

  • Arterial Occlusive Disease
  • Intermittent Claudication

Interventions

DEVICE

Lower extremity Atherectomy and Cryoplasty

Sponsors & Collaborators

Principal Investigators

  • Niren Angle, MD · University of California, San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00407940 on ClinicalTrials.gov