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AzTrials

CADCOASTNCT02132611

Coronary Orbital Atherectomy System Study

A study testing Diamondback 360® Coronary OAS Micro Crown in people with CAD, run by Abbott Medical Devices at 17 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
CAD
What is being tested?
Diamondback 360® Coronary OAS Micro Crown
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
17 sitesin 2 countries
Study dates
Jun 2014to Jun 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

17 sites in 2 countries.

17 sites in 2 countries

United States12 sites

  • Chandler Regional Medical Center and Mercy Gilbert Medical Center

    Chandler, Arizona, 85224

  • Duke University

    Durham, North Carolina, 27705

  • North Florida Regional Medical Center

    Gainesville, Florida, 32605

  • Palm Beach Gardens

    Jupiter, Florida, 33458

  • Mount Sinai Hospital New York

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Munroe Regional Health System, Inc.

    Ocala, Florida, 34471

  • Florida Hospital

    Orlando, Florida, 32803

  • NC Heart and Vascular Research

    Raleigh, North Carolina, 27607

  • St. Francis Hospital

    Roslyn, New York, 11576

  • Baptist Memorial Hospital/Stern Cardiovascular Foundation, Inc.

    Southaven, Mississippi, 38671

  • Tallahassee Research Institute

    Tallahassee, Florida, 32308

Other trials in United States

Japan5 sites

  • Shonan Kamakura General Hospital

    Kamakura, Kanagawa

  • Kyoto Katsura Hospital

    Kyoto, Nishikyo-ku

  • Miyazaki Medical Association Hospital

    Miyazaki, Miyazaki

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, Hokkaido

  • Saiseikai Yokohamashi Tobu Hospital

    Yokohama, Kanagawa

Other trials in Japan

About this study

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).

Read the 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.

Conditions
CAD
Being tested
Diamondback 360® Coronary OAS Micro Crown

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diamondback 360® Coronary OAS Micro CrownDevice

    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.

Study groups in NCT02132611
Study groupRoleWhat they receive
Diamondback 360® Coronary OAS Micro CrownExperimentalDiamondback 360® Coronary Orbital Atherectomy System Micro Crown
Receives: Device: Diamondback 360® Coronary OAS Micro Crown

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Adverse Cardiac Event (MACE)

    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

    Measured: 30 Days

Secondary outcomes (1)

  1. Procedural Success

    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.

    Measured: Participants were followed from baseline procedure through the duration of hospital stay, an average of 50.4 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionSep 2015
  4. Study completionJun 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02132611
Sponsor's protocol ID
CLN-0005-P
Acronym
COAST
Status last verified
Jul 2023
First submitted
6 May 2014
Last updated
18 Jul 2023
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Redfors B, Sharma SK, Saito S, Kini AS, Lee AC, Moses JW, Ali ZA, Feldman RL, Bhatheja R, Stone GW. Novel Micro Crown Orbital Atherectomy for Severe Lesion Calcification: Coronary Orbital Atherectomy System Study (COAST). Circ Cardiovasc Interv. 2020 Aug;13(8):e008993. doi: 10.1161/CIRCINTERVENTIONS.120.008993. Epub 2020 Aug 6.

    PubMed 32757661

  • Martinsen BJ, Kumar K, Saito S, Sharma SK, Ikeno F, Fearnot NE, Shlofmitz RA, Thatcher R, Krucoff MW. Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, Harmonization by Doing Proof-of-Concept. Cardiovasc Revasc Med. 2022 Apr;37:112-117. doi: 10.1016/j.carrev.2021.08.021. Epub 2021 Aug 26.

    PubMed 34607786

Questions about this trial

What is this clinical trial studying?

A study testing Diamondback 360® Coronary OAS Micro Crown in people with CAD, run by Abbott Medical Devices at 17 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Adverse Cardiac Event (MACE) (time frame: 30 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02132611, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.

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