HARMONEE - Japan-USA Harmonized Assessment by Randomized, Multi-Center Study of OrbusNEich's Combo StEnt

Completed · Not applicable

Conditions studied: Coronary Arteriosclerosis, Non ST Segment Elevation Acute Coronary Syndrome

In brief

This is a multi-center, single-blind, randomized, active-controlled, clinical trial in Percutaneous Coronary Intervention (PCI) subjects. Subjects will be randomized to receive the Combo stent as the investigational treatment arm or an Everolimus Eluting Stent (EES) as the active-control arm.

Key facts

Study ID

NCT02073565

Run by

OrbusNeich

People needed

572

Starts

2014-02-01

Expected to finish

2021-12-01

Last updated by the study team

2022-05-13

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• To be eligible for this trial, subjects must meet all of the following criteria:
• Subject is able to verbally confirm understanding of risks, benefits, and treatment alternatives of Combo vs EES stent, and the subject or a legally authorized representative (LAR) must provide written informed consent before any study-related procedures are performed.
• Subject must be at least 20 years of age at the time of randomization.
• Subject must have clinical or functional evidence of myocardial ischemia (eg, stable or unstable angina, stabilized non-ST-elevation myocardial infarction confirmed by serum markers, ischemia by positive functional study, abnormal FFR, or a reversible change in the electrocardiogram (ECG) consistent with ischemia).
• Subject must be acceptable candidate with anatomy suitable for PCI with a DES.
• Subject agrees to return for all study-related follow-up assessments, including invasive OCT follow-up assessment at 6 months (Cohort A) and at 1 year postprocedure (Cohorts A, B, and C).
• Subject is an acceptable candidate for Coronary artery bypass grafting (CABG) surgery.
• Angiographic Anatomy Criteria-
• Target lesions must be located in a native coronary artery with visually estimated diameter of 2.5 mm to 3.5 mm, inclusive, and up to 3 de novo target lesions may be treated, with a maximum of 2 de novo target lesions per epicardial vessel, with a maximum of 2 target vessels.
• Target lesions should be treatable with a single stent, and must measure 28 mm or less in length by visual estimation (2 mm or more of nondiseased tissue on either side of the target lesion should be covered by the study stent).
• If more than 1 target lesion will be treated, the reference vessel diameter and lesion length of each target lesion must meet the above criteria.
• Target lesions must be in a major artery or branch with a visually estimated stenosis of 50% or greater and less than 100% with a Thrombolysis in Myocardial Infarction (TIMI) flow of 1 or greater.
• Previous percutaneous intervention of lesions in a target vessel (including side branches) is allowed if done 9 or more months before the study procedure and greater than 10 mm from the current target lesion.
• Nonstudy percutaneous interventions for lesions in a nontarget vessel are allowed if done 9 or more months before the study procedure, in the absence of documented ischemia or angiographic restenosis related to the vessel.

You may not qualify if…

• If a subject meets any of the following criteria, he or she may not be enrolled in the study:
• ST-Elevation Myocardial Infarction (STEMI) at index presentation or within 7 days of study screening.
• Subject has current unstable arrhythmias or intractable angina with ECG changes or shock requiring pressors or mechanical assist device (intraaortic balloon pump, left ventricular assist device, Impella, etc.).
• Subject has known left ventricular ejection fraction (LVEF) less than 30%.
• Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant.
• Subject is receiving or scheduled to receive anticancer therapy for malignancy within 30 days before or after the procedure.
• Subject is receiving immunosuppression therapy, has known serious immunosuppressive disease (eg, human immunodeficiency virus), or has severe autoimmune disease that requires chronic immunosuppressive therapy (eg, systemic lupus erythematosus).
• Subject has known hypersensitivity or contraindication to aspirin; both heparin and bivalirudin; all available P2Y12 inhibitors (clopidogrel, prasugrel, ticlopidine, and ticagrelor); any everolimus, sirolimus, cobalt, chromium, nickel, tungsten, acrylic, or fluoro polymers; or hypersensitivity to contrast media that cannot be adequately premedicated.
• Subject has previously received murine therapeutic antibodies and exhibited sensitization through the production of human anti-mouse antibodies (HAMAs).
• Subject has elective surgery planned within the first 12 months after the procedure that will require interruption or discontinuation of planned Dual Antiplatelet Therapy (DAPT).
• Subject has known platelet count less than 100,000 cells/mm3 or greater than 700,000 cells/mm3, a white blood cell count of less than 3000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis).
• Subject has known renal insufficiency (eg, serum creatinine level of greater than 2.5 mg/dL or subject is on dialysis).
• Subject has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• Subject has had a cerebrovascular accident or transient ischemic neurological attack within the past 6 months.
• Subject has had a significant gastrointestinal or urinary bleed within the past 6 months.
• Subject has known extensive peripheral vascular disease that precludes safe 6 French sheath insertion.
• Known other medical illness (eg, cancer, chronic infectious disease, severe vascular disease, or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause noncompliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than 1 year.
• Currently participating in another clinical study that has not yet reached its primary endpoint.
• Currently pregnant or breast-feeding or is planning pregnancy in the period up to 1 year following index procedure. Female subjects of childbearing potential must have a negative pregnancy test within 7 days before the index procedure.
• Angiographic Exclusion Criteria-
• If the target lesion meets any of the following criteria, the subject may not be enrolled in the study:
• Unprotected left main coronary artery location.
• Unprotected ostial (located within 2 mm of the origin) left anterior descending artery or left circumflex.
• Located within an arterial or saphenous vein graft or graft anastomosis, distal to a diseased arterial or saphenous vein graft (visually estimated graft diameter stenosis greater than 40%).
• Involves a bifurcation in which the side branch is 2 mm or greater in diameter AND would be covered by the planned stent.

Where it is running

• MedStar Clinical Research Center — Washington D.C., District of Columbia, United States
• Atlantic Clinical Research Collaborative-Cardiology — Lake Worth, Florida, United States
• University of Miami — Miami, Florida, United States
• Tallahassee Research Institute — Tallahassee, Florida, United States
• Emory University Hospital Midtown — Atlanta, Georgia, United States
• North Georgia Heart Foundation — Gainesville, Georgia, United States
• Maine Medical Center — Portland, Maine, United States
• Washington Adventist Hospital — Takoma Park, Maryland, United States
• Lahey Clinic — Burlington, Massachusetts, United States
• North Mississippi Medical Center — Tupelo, Mississippi, United States
• Mount Sinai Medical Center — New York, New York, United States
• University of Rochester Medical Center-Strong Memorial Hospital — Rochester, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Saiseikai Fukuoka General Hospital — Fukoka-shi, Fukuoka, Japan
• Kurume University Hospital — Kurume-shi, Fukuoka, Japan
• Shinkoga Hospital — Kurume-shi, Fukuoka, Japan
• Tsuchiya General Hospital — Hiroshima, Hiroshima, Japan
• Hakodate Municipal Hospital — Hakodate-shi, Hokkaido, Japan
• Sapporo Higashi Tokushukai Hospital — Sapporo, Hokkaido, Japan
• Hyogo Brain and Heart Centre — Himeji-shi, Hyōgo, Japan
• Takahashi Hospital — Kobe, Hyōgo, Japan

Full record on ClinicalTrials.gov

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