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Coronary Orbital Atherectomy System Study (COAST)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Cardiovascular Systems Inc Identifier:
First received: May 6, 2014
Last updated: December 16, 2015
Last verified: December 2015
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).

Condition Intervention
Device: Diamondback 360® Micro Crown OAS

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Coronary Orbital Atherectomy System Study

Resource links provided by NLM:

Further study details as provided by Cardiovascular Systems Inc:

Primary Outcome Measures:
  • Major Adverse Cardiac Event (MACE) [ Time Frame: 30 Days ] [ Designated as safety issue: Yes ]

    30-Day MACE is composed of:

    • Cardiac death
    • Myocardial Infarction (MI) - defined as a Creatinine Kinase Myocardial-Band Isoenzyme (CK-MB) level greater than three (3) time the Upper Limit of Lab Normal (ULN) value with or without new pathologic Q wave
    • Target Vessel Revascularization (TVR) - defined as a revascularization at the target vessel (inclusive of the target lesion) after the completion of the index procedure

Secondary Outcome Measures:
  • Procedural Success [ Time Frame: Procedure ] [ Designated as safety issue: No ]
    Procedural success is defined as success in facilitating stent delivery with a residual stenosis of < 50% and without in-hospital MACE

Estimated Enrollment: 100
Study Start Date: June 2014
Estimated Study Completion Date: August 2018
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Diamondback 360® Micro Crown OAS
Diamondback 360® Micro Crown Orbital Atherectomy System
Device: Diamondback 360® Micro Crown OAS
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.
Other Names:
  • Diamondback 360®
  • Japan: CSI-001

Detailed 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02132611

United States, Arizona
Chandler Regional Medical Center and Mercy Gilbert Medical Center
Chandler, Arizona, United States, 85224
United States, Florida
North Florida Regional Medical Center
Gainesville, Florida, United States, 32605
Palm Beach Gardens
Jupiter, Florida, United States, 33458
Munroe Regional Health System, Inc.
Ocala, Florida, United States, 34471
Florida Hospital
Orlando, Florida, United States, 32803
Tallahassee Research Institute
Tallahassee, Florida, United States, 32308
United States, Mississippi
Stern Cardiovascular Foundation, Inc.
Southaven, Mississippi, United States, 38671
United States, New York
Mount Sinai Hospital New York
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
St. Francis Hospital
Roslyn, New York, United States, 11576
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
NC Heart and Vascular Research
Raleigh, North Carolina, United States, 27607
Sponsors and Collaborators
Cardiovascular Systems Inc
Principal Investigator: Gregg Stone, MD Columbia University
  More Information

Responsible Party: Cardiovascular Systems Inc Identifier: NCT02132611     History of Changes
Other Study ID Numbers: CLN-0005-P 
Study First Received: May 6, 2014
Last Updated: December 16, 2015
Health Authority: United States: Food and Drug Administration
Japan: Ministry of Health, Labor and Welfare processed this record on October 26, 2016