Coronary Orbital Atherectomy System Study

NCT02132611 | Completed Results DMC

• 1 other identifier: CLN-0005-P
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 17

Brief 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).

Conditions

CAD

Outcome Measures

Primary Outcomes (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

  30 Days

Secondary Outcomes (1)

• Procedural Success

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

Study Arms (1)

Diamondback 360® Coronary OAS Micro Crown

EXPERIMENTAL

Diamondback 360® Coronary Orbital Atherectomy System Micro Crown

Device: Diamondback 360® Coronary OAS Micro Crown

Interventions

Diamondback 360® Coronary OAS Micro Crown DEVICE

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.

Diamondback 360® Coronary OAS Micro Crown

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (17)

Chandler Regional Medical Center and Mercy Gilbert Medical Center

Chandler, Arizona, 85224, United States

Location

North Florida Regional Medical Center

Gainesville, Florida, 32605, United States

Location

Palm Beach Gardens

Jupiter, Florida, 33458, United States

Location

Munroe Regional Health System, Inc.

Ocala, Florida, 34471, United States

Location

Florida Hospital

Orlando, Florida, 32803, United States

Location

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

Location

Baptist Memorial Hospital/Stern Cardiovascular Foundation, Inc.

Southaven, Mississippi, 38671, United States

Location

Mount Sinai Hospital New York

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

Location

Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, Japan

Location

Shonan Kamakura General Hospital

Kamakura, Kanagawa, Japan

Location

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Kanagawa, Japan

Location

Miyazaki Medical Association Hospital

Miyazaki, Miyazaki, Japan

Location

Kyoto Katsura Hospital

Kyoto, Nishikyo-ku, Japan

Location

Related Publications (2)

• 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.

  PMID: 32757661 RESULT

• 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.

  PMID: 34607786 RESULT

Results Point of Contact

• Title: Clinical Project Manager
• Organization: Cardiovascular Systems, Inc.

clinicaltrials_csi@csi360.com

651-259-1600

Study Officials

• Gregg Stone, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2014
• First Posted: May 7, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: June 1, 2017
• Last Updated: July 18, 2023
• Results First Posted: October 27, 2016

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

JP (5); US (12)