Coronary Orbital Atherectomy System Study (COAST)

July 14, 2023 updated by: Abbott Medical Devices
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hokkaido
      • Sapporo-city, Hokkaido, Japan
        • Sapporo Higashi Tokushukai Hospital
    • Kanagawa
      • Kamakura-city, Kanagawa, Japan
        • Shonan Kamakura General Hospital
      • Yokohama-shi, Kanagawa, Japan
        • Saiseikai Yokohamashi Tobu Hospital
    • Miyazaki
      • Miyazaki-city, Miyazaki, Japan
        • Miyazaki Medical Association Hospital
    • Nishikyo-ku
      • Kyoto, Nishikyo-ku, Japan
        • Kyoto Katsura Hospital
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Chandler Regional Medical Center and Mercy Gilbert Medical Center
    • Florida
      • Gainesville, Florida, United States, 32605
        • North Florida Regional Medical Center
      • Jupiter, Florida, United States, 33458
        • Palm Beach Gardens
      • Ocala, Florida, United States, 34471
        • Munroe Regional Health System, Inc.
      • Orlando, Florida, United States, 32803
        • Florida Hospital
      • Tallahassee, Florida, United States, 32308
        • Tallahassee Research Institute
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • Baptist Memorial Hospital/Stern Cardiovascular Foundation, Inc.
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10029
        • Mount Sinai Hospital New York
      • Roslyn, New York, United States, 11576
        • St. Francis Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University
      • Raleigh, North Carolina, United States, 27607
        • NC Heart and Vascular Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
30 Days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Participants were followed from baseline procedure through the duration of hospital stay, an average of 50.4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Abbott Medical Devices

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gregg Stone, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2014

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLN-0005-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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