Overview

This trial is active, not recruiting.

Condition cad
Treatment diamondback 360® micro crown oas
Sponsor Cardiovascular Systems Inc
Start date June 2014
End date September 2015
Trial size 100 participants
Trial identifier NCT02132611, CLN-0005-P

Summary

The purpose of the COAST clinical study data will be to utilize and to gain approval in commercializing the micro crown as part of the Coronary Orbital Atherectomy system (OAS).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Diamondback 360® Micro Crown Orbital Atherectomy System
diamondback 360® micro crown oas Diamondback 360®
The Diamondback 360® micro crown OAS consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material and restores luminal patency. During rotation, centrifugal forces press the crown laterally against the coronary plaque, reducing a thin layer of that plaque on the vessel wall.

Primary Outcomes

Measure
Major Adverse Cardiac Event (MACE)
time frame: 30 Days

Secondary Outcomes

Measure
Procedural Success
time frame: Procedure

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - The target vessel must be a native coronary artery - The target vessel reference diameter ≥ 2.5 mm and ≤ 4.0 mm and lesion must not exceed 40 mm in length - The target lesion must have fluoroscopic or IVUS or OCT evidence of severe calcium Exclusion Criteria: - Diagnosed with chronic renal failure, unless under hemodialysis - Experienced acute MI, STEMI or non-STEMI, within 30 days prior to procedure - Evidence of LVEF ≤ 25% or NYHA class III or IV heart failure - More than 1 lesion requiring intervention unless the lesions are staged - Target vessel has suspected thrombus, excessively tortuous or dissection - Target lesion is an ostial location, bifurcation or has a ≥ 1.5 mm side branch

Additional Information

Official title Coronary Orbital Atherectomy System Study
Principal investigator Gregg Stone, MD
Description This is a prospective, single-arm, multi-center, global study designed to evaluate performance of the Diamondback 360® Coronary Micro Crown Orbital Atherectomy System (micro crown OAS) in treating de novo, severely calcified coronary lesions.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Cardiovascular Systems Inc.