NCT02132611

Coronary Orbital Atherectomy System Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the COAST clinical study data will be to utilize and to gain approval for commercializing the Micro Crown as part of the Coronary Orbital Atherectomy System (OAS).

Detailed description

This is a prospective, single-arm, multi-center, global study designed to evaluate performance of the Diamondback 360® Coronary Orbital Atherectomy System Micro Crown (OAS Micro Crown) in treating de novo, severely calcified coronary lesions.

Conditions

• CAD

Interventions

Type	Name	Description
DEVICE	Diamondback 360® Coronary OAS Micro Crown	The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-09-01
• Completion: 2017-06-01
• First posted: 2014-05-07
• Last updated: 2023-07-18
• Results posted: 2016-10-27

Locations

17 sites across 2 countries: United States, Japan