Coronary Orbital Atherectomy System Study

Status:	Active, not recruiting
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	June 2014
End Date:	August 2018

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).

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.

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

We found this trial at

sites

Duke University

Durham, North Carolina 27710

(919) 684-8111