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).
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.
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
12
sites
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Florida Hospital Florida Hospital is one of the country
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