NCT01941030

Complete Lesion Assessment With ffR and IVUS TechnologY

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Peripheral Artery Disease
• Critical Limb Ischemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2013-09-13
• Last updated: 2023-07-18
• Results posted: 2019-01-24

Locations

8 sites across 1 country: United States