2,008
Participants
Start Date
December 31, 2012
Primary Completion Date
September 30, 2016
Study Completion Date
October 31, 2020
Absorb BVS
"* Scaffold diameters: 2.5, 3.0 and 3.5 mm~* Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. 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.~* 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~* Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition~* 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."
St. Vincent's Hospital Melbourne, Fitzroy
Royal Brisbane and Women's Hospital, Herston
Mount Sinai Medical Center, New York
Columbia University Medical Center, New York
New York Presbyterian Hospital-Cornell University, New York
Lennox Hill Hospital,, New York
Montefiore Medical Center, The Bronx
Long Island Jewish Medical Center, Manhasset
Winthrop University Hospital, Mineola
Stony Brook University Medical Center, Stony Brook
St. Joseph's Hospital Health Center, Liverpool
Rochester General Hospital, Rochester
Strong Memorial Hospital, Rochester
Allegheny General Hospital, Pittsburgh
UPMC Presbyterian, Pittsburgh
UPMC Shadyside Hospital, Pittsburgh
UPMC Hamot, Erie
Holy Spirit Hospital, Camp Hill
Pinnacle Health at Harrisburg Hospital, Wormleysburg
York Hospital, York
Geisinger Medical Center, Danville
Doylestown Hospital, Doylestown
Abington Memorial Hospital, Abington
St. Mary Medical Center, Langhorne
Penn Presbyterian Medical Center, Philadelphia
Pennsylvania Hospital, Philadelphia
St. Joseph Medical Center, Wyomissing
Christiana Care Health Services, Newark
MedStar Washington Hospital Center, Hyattsville
Union Memorial Hospital, Hyattsville
Washington Adventist Hospital, Takoma Park
Peninsula Regional Medical Center, Salisbury
Inova Fairfax Hospital, Falls Church
Mary Washington Hospital, Fredericksburg
Winchester Medical Center, Winchester
Sentara Norfolk General Hospital, Norfolk
Carilion Roanoke Memorial Hospital, Roanoke
St. Mary's Medical Center, Huntington
Novant Health Forsyth Medical Center, Winston-Salem
Duke University Medical Center, Durham
Wake Forest University Baptist Medical Center, Winston-Salem
Rex Hospital, Raleigh
WakeMed, Raleigh
Carolinas Medical Center, Charlotte
Presbyterian Hospital, Charlotte
Sisters of Charity Providence Hospital, Columbia
Medical University of South Carolina, Charleston
Greenville Memorial Hospital of the Greenville Health System, Greenville
St. Francis Health System, Greenville
AnMed Health, Anderson
Wellstar Kennestone Hospital, Marietta
Piedmont Hospital, Atlanta
Emory University Hospital, Atlanta
Saint Joseph's Hospital of Atlanta, Atlanta
Northeast Georgia Medical Center, Gainesville
University Hospital, Augusta
St. Vincent's Medical Center, Jacksonville
Baptist Medical Center - Downtown, Jacksonville
University of Florida UF Health, Jacksonville
Tallahassee Memorial Hospital, Tallahassee
Bay County Health Systems, Panama City
Baptist Hospital, Pensacola
Florida Hospital, Orlando
Memorial Regional Hospital, Hollywood
University of Miami Hospital, Miami
Baptist Hospital of Miami, Miami
Holy Cross Hospital, Fort Lauderdale
Palm Beach Gardens Medical Center, Palm Beach Gardens
Brandon Regional Hospital, Brandon
Tampa General Hospital, Tampa
Florida Hospital Pepin Heart Institute, Tampa
Morton Plant Hospital, Clearwater
MediQuest Research Group Inc at Munroe Regional Medical Center, Ocala
Baptist Medical Center Princeton, Birmingham
University of Alabama Hospital, Birmingham
Baptist Medical Center South, Montgomery
Thomas Hospital, Fairhope
Vanderbilt University Medical Center, Nashville
Memorial Hospital, Chattanooga
Wellmont Holston Valley Medical Center, Kingsport
Turkey Creek Medical Center, Knoxville
North Mississippi Medical Center Cardiology Associates Research, LLC, Tupelo
Jewish Hospital, Louisville
Baptist Health Lexington, Lexington
University of Kentucky Medical Center, Lexington
Ohio State University Medical Center, Columbus
Riverside Methodist Hospital, Columbus
The Toledo Hospital, Toledo
Mercy St. Vincent's Medical Center, Toledo
Genesis-Good Samaritan Hospital, Zanesville
EMH Healthcare, Elyria
University Hospitals of Cleveland, Cleveland
Cleveland Cln Fairview Hospital, Fairview Park
Cleveland Clinic, Cleveland
Aultman Hospital, Canton
University Hospital, Cincinnati
The Christ Hospital, Cincinnati
Tri-Health Good Samaritan Hospital, Cincinnati
Bethesda North Hospital, Cincinnati
Kettering Medical Center, Kettering
Indiana University Health Methodist Hospital, Indianapolis
Franciscan St. Francis Health, Indianapolis
St. Vincent Heart Center of Indiana, Indianapolis
Elkhart General Healthcare, Elkhart
Oakwood Hospital and Medical Center, Dearborn
St. Joseph Mercy Hospital, Ypsilanti
Harper University Hospital, Detroit
Henry Ford Hospital, Detroit
St. John Hospital & Medical Center, Detroit
William Beaumont Hospital, Royal Oak
Bay Regional Medical Center, Bay City
Sparrow Hospital, Lansing
Borgess Medical Center, Kalamazoo
Munson Medical Center, Traverse City
Northern Michigan Hospital, Petoskey
Mercy Medical, West Des Moines
Genesis Medical Center, Davenport
Aurora St. Luke's Medical Center, Milwaukee
Abbott Northwestern Hospital, Minneapolis
North Memorial Medical Center, Robbinsdale
Sanford USD Medical Center, Sioux Falls
St. Patrick Hospital, Missoula
Advocate Christ Medical Center, Oak Lawn
Northwestern Memorial Hospital, Chicago
Saint Francis Medical Center, Peoria
St. John's Hospital, Springfield
Barnes Jewish Hospital, St Louis
St. Anthony's Medical Center, St Louis
Boone Hospital Center, Columbia
Mercy Hospital Springfield, Springfield
The University of Kansas Hospital and Medical Center, Kansas City
Nebraska Heart Hospital, Lincoln
Arkansas Heart Hospital, Little Rock
Integris Baptist Medical Center, Oklahoma City
Oklahoma Heart Hospital, Oklahoma City
Hillcrest Medical Center, Tulsa
The Heart Hospital Baylor Plano, Plano
Baylor Jack and Jane Hamilton Heart and Vascular Hospital, Dallas
East Texas Medical Center, Tyler
Trinity Mother Frances Hospital Regional Healthcare Center, Tyler
St. Luke's Episcopal Hospital, Houston
The Methodist Hospital Research Institute, Houston
Methodist Texsan Hospital, San Antonio
Seton Medical Center Austin, Austin
Northwest Texas Healthcare System, Amarillo
Medical Center of the Rockies, Fort Collins
UCH-Memorial Health Systems, Colorado Springs
InterMountain Medical Center, Murray
Banner Good Samaritan Medical Center, Phoenix
Banner Heart Hospital, Mesa
Scottsdale Healthcare, Scottsdale
Chandler Regional Medical Center, Gilbert
Presbyterian Hospital, Albuquerque
Good Samaritan Hospital, Los Angeles
Cedars-Sinai Medical Center, Los Angeles
Little Company Of Mary Hospital, Torrance
Torrance Memorial Medical Center, Torrance
Scripps Green Hospital, La Jolla
Scripps Memorial Hospital, La Jolla
Sharp Memorial Hospital, San Diego
Santa Barbara Cottage Hospital, Santa Barbara
Stanford Hospital and Clinics, Stanford
John Muir Medical Center - Concord Campus, Concord
Washington Hospital, Fremont
Sutter Central Valley Hospitals dba Memorial Medical Center, Modesto
Mercy General Hospital, Sacramento
UC Davis Medical Center, Sacramento
Sutter Medical Center, Sacramento
Providence St. Vincent Medical Center, Portland
PeaceHealth Sacred Heart Medical Center, Springfield
Swedish Medical Center, Seattle
Providence Regional Medical Center Everett, Everett
St. Joseph Hospital, Bellingham
Yale-New Haven Hospital, New Haven
St. Vincent's Medical Center, Stamford
Eastern Maine Medical Center, Bangor
Maine Medical Center, Portland
Brigham and Women's Hospital, Boston
Boston University Medical Center, Boston
St. Elizabeth's Medical Center of Boston, Brighton
UMass Memorial Medical Center, Worcester
Dartmouth-Hitchcock Medical Center, Lebanon
Englewood Hospital and Medical Center, Englewood
Cooper University Hospital, Haddon Heights
Our Lady of Lourdes Medical Center, Haddon Heights
Morristown Medical Center, Morristown
Jersey Shore University Medical Center, Neptune City
St. Joseph's Regional Medical Center, Paterson
The Valley Hospital, Ridgewood
Rhode Island Hospital, Providence
The Miriam Hospital, Providence
Fletcher Allen Health Care, Burlington
Lead Sponsor
Abbott Medical Devices
INDUSTRY