Clinical trial NCT02132611: Coronary Orbital Atherectomy System Study
Official title: Coronary Orbital Atherectomy System Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CAD
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2014-05-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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 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.

Primary outcomes:
measure: Major Adverse Cardiac Event (MACE)
timeFrame: 30 Days
Secondary outcomes:
measure: Procedural Success
timeFrame: Participants were followed from baseline procedure through the duration of hospital stay, an average of 50.4 hours
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Chandler Regional Medical Center and Mercy Gilbert Medical Center
state: Arizona
city: Gainesville
country: United States
facility: North Florida Regional Medical Center
state: Florida
city: Jupiter
country: United States
facility: Palm Beach Gardens
state: Florida
city: Ocala
country: United States
facility: Munroe Regional Health System, Inc.
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Southaven
country: United States
facility: Baptist Memorial Hospital/Stern Cardiovascular Foundation, Inc.
state: Mississippi
city: New York
country: United States
facility: Mount Sinai Hospital New York
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Raleigh
country: United States
facility: NC Heart and Vascular Research
state: North Carolina
city: Sapporo-city
country: Japan
facility: Sapporo Higashi Tokushukai Hospital
state: Hokkaido
city: Kamakura-city
country: Japan
facility: Shonan Kamakura General Hospital
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Saiseikai Yokohamashi Tobu Hospital
state: Kanagawa
city: Miyazaki-city
country: Japan
facility: Miyazaki Medical Association Hospital
state: Miyazaki
city: Kyoto
country: Japan
facility: Kyoto Katsura Hospital
state: Nishikyo-ku
Study officials:
affiliation: Columbia University
name: Gregg Stone, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.