Coronary Orbital Atherectomy System Study

NCT ID: NCT02132611

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2017-06-30

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.

Conditions

CAD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Diamondback 360® Coronary OAS Micro Crown

Diamondback 360® Coronary Orbital Atherectomy System Micro Crown

Group Type: EXPERIMENTAL

Diamondback 360® Coronary OAS Micro Crown

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregg Stone, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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

Countries

United States; Japan

References

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.

Reference Type: RESULT

PMID: 32757661 (View on PubMed)

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.

Reference Type: RESULT

PMID: 34607786 (View on PubMed)

Other Identifiers

CLN-0005-P

Identifier Type: -

Identifier Source: org_study_id