Coronary Orbital Atherectomy System Study

Completed · Not applicable

Conditions studied: CAD

In brief

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).

Key facts

Study ID

NCT02132611

Run by

Abbott Medical Devices

People needed

100

Starts

2014-06-01

Expected to finish

2017-06-01

Last updated by the study team

2023-07-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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