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Complete Lesion Assessment With ffR and IVUS TechnologY

NCT01941030 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2023-07-18

Study results available
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Summary

CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger, statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia (CLI).

Conditions

Interventions

DEVICE

Orbital Atherectomy System

Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)

DEVICE

Balloon Angioplasty

Type of balloon selected is driven by preference of the operator.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Raymond Dattilo, M.D. · St. Francis Heart and Vascular Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01941030 on ClinicalTrials.gov