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

NACompletedINTERVENTIONAL
Enrollment

572

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

July 14, 2017

Study Completion Date

December 31, 2021

Conditions
Coronary ArteriosclerosisNon ST Segment Elevation Acute Coronary Syndrome
Interventions
DEVICE

OrbusNeich Combo stent™

The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.

DEVICE

Everolimus Eluting Stent (EES)

Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V.

Trial Locations (50)

10029

Mount Sinai Medical Center, New York

14642

University of Rochester Medical Center-Strong Memorial Hospital, Rochester

18103

Lehigh Valley Hospital, Allentown

20010

MedStar Clinical Research Center, Washington D.C.

20912

Washington Adventist Hospital, Takoma Park

27157

Wake Forest Baptist Medical Center, Winston-Salem

27705

Duke University Medical Center, Durham

30308

Emory University Hospital Midtown, Atlanta

30501

North Georgia Heart Foundation, Gainesville

32308

Tallahassee Research Institute, Tallahassee

33136

University of Miami, Miami

33462

Atlantic Clinical Research Collaborative-Cardiology, Lake Worth

37232

Vanderbilt University Medical Center, Nashville

38801

North Mississippi Medical Center, Tupelo

43210

The Ohio State University Medical Center, Columbus

04102

Maine Medical Center, Portland

01805

Lahey Clinic, Burlington

810-0001

Saiseikai Fukuoka General Hospital, Fukoka-shi

830-0011

Kurume University Hospital, Kurume-shi

830-8577

Shinkoga Hospital, Kurume-shi

730-655

Tsuchiya General Hospital, Hiroshima

041-8680

Hakodate Municipal Hospital, Hakodate-shi

065-0033

Sapporo Higashi Tokushukai Hospital, Sapporo

670-0981

Hyogo Brain and Heart Centre, Himeji-shi

654-0026

Takahashi Hospital, Kobe

665-0873

Higashi Takarazuka Satoh Hospital, Takarazukasi

300-0053

Tsuchiura Kyodo Hospital, Tsuchiura

920-0007

Kanazawa Cardiovascular Hospital, Kanazawa

892-0583

National Hospital Organisation Kagoshima Medical Centre, Kagoshima

247-8533

Shonan Kamakura General Hospital, Okamoto

211-8510

Kanto Rosai Hospital, Kawasaki-shi

230-8765

Saiseikai Yokohamashi Tobu Hospital, Yokohama

615-8256

Kyoto-Katsura Hospital, Kyoto

880-0834

Miyazaki Medical Association Hospital, Miyazaki

710-8602

Kurashiki Central Hospital, Kurashiki-shi

700-0804

The Sakakibara Heart Institute of Okayama, Okayama

530-0001

Sakurabashi Watanabe Hospital, Osaka

530-0012

Osaka Saiseikai Nakatsu Hospital, Osaka

849-8501

Saga University Hospital, Saga

360-0197

Saitama Prefectural Cardiovascular and Respiratory Disease Centre, Kumagaya-shi

411-0904

Okamura Memorial Hospital, Suntou-gun

329-0498

Jichi Medical University Hospital, Shimotsuke-shi

113-8421

Department of Cardiovascular Medicine, Juntendo University School of Medicine, Bunkyo-ku

183-0003

Sakakibara Memorial Hospital, Fuchu-shi

173-8606

Teikyo University Hospital, Itabashi-ku

153-8515

Toho University Ohashi Hospital, Meguro-ku

106-0031

The Cardiovascular Institute Hospital, Minato-ku

142-8666

Showa University Hospital, Shinagawa-ku

160-8582

Cardiac Catheterisation Laboratory, Keio University School of Medicine, Shinjuku-ku

162-8666

Tokyo Women's Medical University Hospital, Shinjuku-ku

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

OrbusNeich Medical K.K.

UNKNOWN

collaborator

Duke Clinical Research Institute

OTHER

lead

OrbusNeich

INDUSTRY