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Coronary Orbital Atherectomy System Study (COAST)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cardiovascular Systems Inc
ClinicalTrials.gov Identifier:
NCT02132611
First received: May 6, 2014
Last updated: November 17, 2016
Last verified: November 2016
  Purpose
The purpose of the COAST clinical study data will be to utilize and to gain approval for commercializing the Micro Crown as part of the Coronary Orbital Atherectomy System (OAS).

Condition Intervention
CAD Device: Diamondback 360® Coronary OAS Micro Crown

Study Type: Interventional
Study Design: 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 ]

    A Kaplan-Meier analysis was performed to determine the percent probability that a study participant is free from major adverse cardiac events at 30 days.

    30-Day MACE is composed of:

    • Cardiac death
    • Myocardial Infarction (MI) - defined as a Creatine Kinase Myocardial-Band Isoenzyme (CK-MB) level greater than three (3) times 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: Participants were followed from baseline procedure through the duration of hospital stay, an average of 50.4 hours ]
    Procedural success was defined as success in facilitating stent delivery with a residual stenosis of <50% and without the occurrence of an in-hospital MACE in de novo, severely calcified coronary lesions.


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® Coronary OAS Micro Crown
Diamondback 360® Coronary Orbital Atherectomy System Micro Crown
Device: Diamondback 360® Coronary OAS Micro Crown
The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.

Detailed Description:
This is a prospective, single-arm, multi-center, global study designed to evaluate performance of the Diamondback 360® Coronary Orbital Atherectomy System Micro Crown (OAS Micro Crown) in treating de novo, severely calcified coronary lesions.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be 18 or older.
  • Subjects must have a clinical indication for coronary intervention.
  • CK and CK-MB must be less than or equal to the upper limit of lab normal value within 8 hours prior to the procedure.
  • The target lesion must be a de novo coronary lesion that has not been previously treated with any interventional procedure.
  • The target vessel must be a native coronary artery.
  • The target vessel reference diameter must be >= 2.5mm and <= 4.0 mm.
  • The lesion length must not exceed 40 mm.
  • The target vessel must have a TIMI flow three (3) at baseline.
  • The target lesion must have fluoroscopic, IVUS or OCT evidence of severe calcium deposit at the lesion site.
  • The lesion must be crossable with the study guide wire.

Exclusion Criteria:

  • Inability to understand the study requirements or has a history of non-compliance with medical advice.
  • Unwilling to sign the COAST ICF.
  • History of any cognitive or mental health status that would interfere with study participation.
  • Currently enrolled in any other pre-approval investigational study.
  • Female subjects who are pregnant or planning to become pregnant within the study period.
  • Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel without adequate alternative medications.
  • Known sensitivity to contrast media, which cannot be adequately pre-medicated.
  • Diagnosed with chronic renal failure unless under hemodialysis, or has a serum creatinine level > 2.5 mg/dl.
  • Experienced acute MI, STEMI or non-STEMI: CK-MB greater than the upper limit of lab normal value, within 30 days prior to index procedure.
  • History of major cardiac intervention within 30 days.
  • Evidence of heart failure
  • History of a stroke or TIA within six (6) months.
  • Active peptic ulcer or upper GI bleeding within six (6) months.
  • History of bleeding diathesis or coagulopathy or intention to refuse blood transfusion, if one should become necessary.
  • Concurrent medical condition with a life expectancy of < 12 months.
  • History of immune deficiency.
  • Uncontrolled insulin dependent diabetes.
  • Evidence of active infections on the day of the index procedure.
  • Subject has planned cardiovascular intervention within 60 days post index procedure.
  • Subject is not an acceptable candidate for emergent CABG surgery.
  • Subject with known allergy to atherectomy lubricant components such as soybean oil, egg yolk phospholipids, glycerin and sodium hydroxide.
  • Subject with angiographically confirmed evidence of more than one (1) lesion requiring intervention, unless the treatment of the lesions is staged.
  • Target lesion is located in a native vessel distal to anastomosis with a saphenous vein graft or LIMA/RIMA bypass.
  • Target vessel has other lesions with greater than 50% diameter stenosis based on visual estimate or on-line QCA.
  • Target vessel has angiographically visible or suspected thrombus.
  • Target vessel has a stent from previous PCI.
  • Target vessel appears to be or is excessively tortuous at baseline.
  • Target lesion is an ostial location (within 5 mm of ostium) or an unprotected left main lesion.
  • Target lesion is a bifurcation.
  • Target lesion has a ≥ 1.5 mm side branch.
  • Angiographic evidence of a dissection prior to initiation of OAD.
  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

Locations
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
Baptist Memorial Hospital/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
Japan
Sapporo Higashi Tokushukai Hospital
Sapporo‐city, Hokkaido, Japan
Shonan Kamakura General Hospital
Kamakura‐city, Kanagawa, Japan
Saiseikai Yokohamashi Tobu Hospital
Yokohama‐shi, Kanagawa, Japan
Miyazaki Medical Association Hospital
Miyazaki‐city, Miyazaki, Japan
Kyoto Katsura Hospital
Kyoto, Nishikyo‐ku, Japan
Sponsors and Collaborators
Cardiovascular Systems Inc
Investigators
Principal Investigator: Gregg Stone, MD Columbia University
  More Information

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
Results First Received: September 6, 2016
Last Updated: November 17, 2016
Individual Participant Data  
Plan to Share IPD: No

ClinicalTrials.gov processed this record on June 23, 2017