Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Coronary Orbital Atherectomy System Study (COAST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Cardiovascular Systems Inc
Sponsor:
Information provided by (Responsible Party):
Cardiovascular Systems Inc
ClinicalTrials.gov Identifier:
NCT02132611
First received: May 6, 2014
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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
CAD
Device: Diamondback 360® 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 Primary Completion Date: August 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® 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT02132611

Contacts
Contact: Janet A Larson 612-743-4499 jlarson@csi360.com

Locations
United States, Arizona
Chandler Regional Medical Center and Mercy Gilbert Medical Center Not yet recruiting
Chandler, Arizona, United States, 85224
Contact: Stephanie Hart    480-728-9971      
Principal Investigator: Georges Nseir, MD         
United States, District of Columbia
Washington Hospital Center/MedStar Not yet recruiting
Washington, District of Columbia, United States, 20010
Contact: Deysik Duque       deysi.k.duque@medstar.net   
Principal Investigator: Ron Waksman, MD         
United States, Florida
North Florida Regional Medical Center Recruiting
Gainesville, Florida, United States, 32605
Contact: Alice Boyette    352-727-1006      
Principal Investigator: Arthur Lee, MD         
Principal Investigator: Steven Roark, MD         
Palm Beach Gardens Not yet recruiting
Jupiter, Florida, United States, 33458
Contact: Miriam Johnson    561-383-3333      
Principal Investigator: Augusto Villa, MD         
Munroe Regional Health System, Inc. Not yet recruiting
Ocala, Florida, United States, 34471
Contact: Rhonda Grubbs, LPN, CCRC    352-351-7337      
Principal Investigator: Robert Feldman, MD         
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Contact: Kimberly Mink    407-303-5600 ext 110-2249      
Principal Investigator: Rohit Bhatheja, MD         
United States, Mississippi
Stern Cardiovascular Foundation, Inc. Not yet recruiting
Southaven, Mississippi, United States, 38671
Contact: Diana Barker    901-312-2668      
Principal Investigator: Steven Himmelstein, MD         
United States, New York
Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Contact: Kate Dalton, RD, CRC    212-342-1820      
Principal Investigator: Jeffrey Moses, MD         
Mount Sinai Hospital New York Not yet recruiting
New York, New York, United States, 10029
Contact: Omar Meelu    212-731-4640      
Principal Investigator: Samin Sharma, MD         
St. Francis Hospital Recruiting
Roslyn, New York, United States, 11576
Contact: Elizabeth Haag    516-562-6790      
Principal Investigator: Richard Shlofmitz, MD         
United States, North Carolina
Duke University Not yet recruiting
Durham, North Carolina, United States, 27705
Contact: Jennifer Hamill    919-681-4680      
Principal Investigator: Manesh Patel, MD         
United States, Washington
University of Washington Not yet recruiting
Seattle, Washington, United States, 98195
Contact: Rebecca Letterer, RN    206-543-6850      
Principal Investigator: James McCabe, MD         
Principal Investigator: Mark Reisman, MD         
Sponsors and Collaborators
Cardiovascular Systems Inc
  More Information

No publications provided

Responsible Party: Cardiovascular Systems Inc
ClinicalTrials.gov Identifier: NCT02132611     History of Changes
Other Study ID Numbers: CLN-0005-P
Study First Received: May 6, 2014
Last Updated: July 17, 2014
Health Authority: United States: Food and Drug Administration
Japan: Ministry of Health, Labor and Welfare

ClinicalTrials.gov processed this record on November 20, 2014