2,604
Participants
Start Date
July 31, 2014
Primary Completion Date
April 6, 2022
Study Completion Date
April 6, 2022
Absorb BVS
"* Scaffold diameters: 2.5, 3.0 and 3.5 mm~* Scaffold lengths: 8, 12, 18, and 28 mm. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.~* Once Absorb GT1™ BVS System is commercially available, it can also be used in the ABSORB IV trial. Scaffold diameters: 2.5, 3.0 and 3.5 mm of and scaffold lengths: 8, 12, 18, 23, and 28 mm.~* The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
XIENCE
"Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).~* Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm. The 3.25 mm is only available for XIENCE Xpedition~* Stent lengths: 8, 12, 15, 18, 23, and 28 mm~* For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
Liverpool Hospital, Liverpool
St Vincent's Hospital Melbourne, Fitzroy
Royal Brisbane and Women's Hospital, Herston
The Prince Charles Hospital, Brisbane
Royal Perth Hospital, Perth
Fiona Stanley Hospital, Murdoch
NYP Weill Cornell Medical Center, New York
Mount Sinai Medical Center, New York
Columbia University Medical Center, New York
Montefiore Medical Center, The Bronx
NewYork-Presbyterian/Queens, Flushing
Stony Brook University Medical Center, Stony Brook
St. Joseph's Hospital Health Center, Syracuse
Rochester General Hospital, Rochester
Forbes Hospital, Monroeville
Allegheny General Hospital, Pittsburgh
Upmc Presbyterian, Pittsburgh
Immanuel Klinikum Bernau Herzzentrum Brandenburg, Bernau
Holy Spirit Hospital, Camp Hill
Geisinger Medical Center, Danville
Doylestown Hospital, Doylestown
Penn Presbyterian Medical Center, Philadelphia
St. Joseph Medical Center, Reading
Medstar Health Research Institute/ Medstar Washington Hospital Center, Northwest
MedStar Union Memorial Hospital, Baltimore
Winchester Medical Center, Winchester
Segeberger Kliniken GmbH - Herzzentrum, Bad Segeberg
Carilion Roanoke Memorial Hospital, Roanoke
Klinikum Oldenburg, Oldenburg
Wake Forest Baptist Medical Center, Winston-Salem
Rex Hospital, Inc., Raleigh
WakeMed, Raleigh
Carolinas Medical Center-Northeast, Charlotte
Carolinas Medical Center, Charlotte
Novant Health Heart & Vascular Institute/Presbyterian Hospital, Charlotte
Carolinas Medical Center-Pineville, Charlotte
Providence Hospital, Columbia
Anmed Health Medical Center, Anderson
Emory University Hospital Midtown, Atlanta
Emory University Hospital, Atlanta
Baptist Medical Center Jacksonville, Jacksonville
UF Health Jacksonville, Jacksonville
Tallahassee Memorial Hospital, Tallahassee
Holy Cross Hospital, Fort Lauderdale
Tampa General Hospital, Tampa
Morton Plant Hospital, Clearwater
University of Alabama at Birmingham, Birmingham
University Giessen, Giessen
Vanderbilt University Medical Center, Nashville
Wellmont Holston Valley Medical Center, Kingsport
North Mississippi Medical Center, Tupelo
Jewish Hospital, Louisville
Baptist Health Lexington, Lexington
University Of Kentucky Hospital, Lexington
Ohio State University Medical Center, Columbus
Mercy St. Vincent Medical Center, Toledo
Genesis Hospital, Zanesville
Cleveland Clinic, Cleveland
Aultman Hospital, Canton
Elisabeth-Krankenhaus, Essen
The Christ Hospital, Cincinnati
Franciscan St Francis Health, Indianapolis
Elkhart General Hospital, Elkhart
William Beaumont Hospital, Royal Oak
St. Joseph Mercy Hospital, Ann Arbor
Harper University Hospital, Detroit
St John Hospital & Medical Center, Detroit
Northern Michigan Hospital, Petoskey
Universitatsklinikum Bonn, Bonn
Johannes Gutenberg-Universitaet, Mainz
St. Patrick Hospital, Missoula
Advocate Christ Medical Center, Oak Lawn
Northwestern Memorial Hospital, Chicago
St. John's Hospital, Springfield
Barnes Jewish Hospital, St Louis
Boone Hospital Center/ Missouri Cardiovascular Specialists, LLP, Columbia
Mercy Hospital Springfield, Springfield
CHI Health Bergan Mercy, Omaha
Nebraska Heart Institute Heart Hosp., Lincoln
Ochsner Clinic Foundation, New Orleans
Arkansas Heart Hospital, Little Rock
Integris Baptist Medical Center, Inc., Oklahoma City
Baylor Heart and Vascular Hospital, Dallas
East Texas Medical Center, Tyler
Houston Methodist Hospital, Houston
Seton Medical Center, Austin
Northwest Texas Healthcare System, Amarillo
Universitatsklinikum Freiburg, Freiburg im Breisgau
Medical Center of the Rockies, Loveland
Chandler Regional Medical Center, Chandler
Scottsdale Healthcare, Scottsdale
Mercy Gilbert Medical Center, Gilbert
Klinikum Kempten, Klinikverbund Kempten-Oberallgaeu gGmbH, Kempten (Allgäu)
Kliniken Oberallgau gGmbH, Immenstadt im Allgäu
Universitätsklinikum Ulm, Ulm
Cedars-Sinai Medical Center, Los Angeles
Little Company Of Mary Hospital, Torrance
Scripps Memorial Hospital La Jolla, La Jolla
Sharp Memorial Hospital, San Diego
Stanford Hospital and Clinics, Stanford
John Muir Health Concord, Concord
Washington Hospital, Fremont
Univ Of California Davis Med Ctr, Sacramento
Providence St. Vincent Medical Center, Portland
Providence Reg Med Ctr Everett, Everett
National Heart Centre, Singapore, Pte, Ltd., Singapore
Yale-New Haven Hospital, New Haven
Eastern Maine Medical Center, Bangor
Boston Medical Center, Boston
Dartmouth Hitchcock Medical Center, Lebanon
Cooper University Hospital, Camden
Our Lady of Lourdes Medical Center, Camden
Englewood Hospital and Medical Center, Englewood
Pinnacle Health Hospitals, Harrisburg
Rhode Island Hospital, Providence
The Miriam Hospital, Providence
St. Michael's Hospital, Toronto
Montreal Heart Institute, Montreal
Hopital du Sacre-Coeur de Montreal, Montreal
CHUM-Hotel Dieu, Montreal
Lead Sponsor
Abbott Medical Devices
INDUSTRY