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Complete Lesion Assessment With ffR and IVUS TechnologY — CLARITY I  

Peripheral Artery Disease Clinical Trial

Official title:
Complete Lesion Assessment With ffR and IVUS TechnologY (CLARITY I)

Clinical Trial 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).

Clinical Trial Description

This prospective, randomized, multi-center, post-market study of approximately 50 subjects randomized 1:1 to Orbital Atherectomy (OA) performed with Cardiovascular Systems, Inc.'s Orbital Atherectomy System (OAS) followed by adjunctive balloon angioplasty (BA) vs. BA alone for treatment of tibial vessel disease, defined as ≥ 50 % stenosis of the anterior tibial (AT), posterior tibial (PT), tibial peroneal trunk (TPT), or peroneal (PR) arteries by angiography. All subjects will have a corresponding wound being fed by the target vessel which will be assessed during the study. Subjects will be followed to one year. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01941030
Study type Interventional
Source Abbott Medical Devices
Contact
Status Completed
Phase N/A
Start date March 2013
Completion date June 2015
View Details
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