Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
1120 participants
OBSERVATIONAL
2011-09-30
2015-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ION Registry
The ION Registry population was designed to collect real world safety and clinical outcomes data. There were 1120 subjects were enrolled, however 9 subjects did not receive a study stent therefore 1111 subjects were eligible for follow up.
ION™ Coronary Stent System
This study is intended to evaluate the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System across a range of institutions and physician users to observe and assess subject outcomes and technology performance in a real-world setting.
Interventions
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ION™ Coronary Stent System
This study is intended to evaluate the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System across a range of institutions and physician users to observe and assess subject outcomes and technology performance in a real-world setting.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
110 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Louis A Cannon, MD
Role: PRINCIPAL_INVESTIGATOR
Northern Michigan Hospital
Carey D Kimmelstiel, MD
Role: PRINCIPAL_INVESTIGATOR
Tufts Medical Center
Locations
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NEA Baptist Memorial Hospital
Jonesboro, Arkansas, United States
St. Bernard's Medical Center
Jonesboro, Arkansas, United States
Bakersfield Memorial Hospital
Bakersfield, California, United States
Alvarado Hospital
San Diego, California, United States
Northside Hospital and Heart Institute
St. Petersburg, Florida, United States
University Community Hospital
Tampa, Florida, United States
Redmond Regional Medical Center
Rome, Georgia, United States
Kootenai Medical Center
Coeur d'Alene, Idaho, United States
Krannert Institute of Cardiology
Indianapolis, Indiana, United States
Indiana Heart Hospital
Indianapolis, Indiana, United States
Iowa Heart Center
West Des Moines, Iowa, United States
King's Daughters Medical Center - Kentucky Heart Inst
Ashland, Kentucky, United States
Maine Medical Center
Portland, Maine, United States
Union Memorial Hospital
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Sparrow Health System - Sparrow Hospital
Lansing, Michigan, United States
Northern Michigan Hospital
Petoskey, Michigan, United States
Lakeland Hospitals at St. Joseph
Saint Joseph, Michigan, United States
Memorial Hospital at Gulfport
Gulfport, Mississippi, United States
Freeman West Hospital
Joplin, Missouri, United States
Our Lady of Lourdes Medical Center
Haddon Heights, New Jersey, United States
Jersey Shore University Medical Center
Sea Girt, New Jersey, United States
St. Joseph's Hospital Health Center
Liverpool, New York, United States
St. Elizabeth Medical Center
Utica, New York, United States
Wake Medical Center
Raleigh, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Mercy St. Vincent Medical Center
Toledo, Ohio, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
St. Mary Medical Center
Yardley, Pennsylvania, United States
Sisters of Charity Providence Hospital
Columbia, South Carolina, United States
Grand Strand Regional Medical Center
Myrtle Beach, South Carolina, United States
Regional Hospital
Jackson, Tennessee, United States
Centennial Medical Center
Nashville, Tennessee, United States
Baylor Heart & Vascular Hospital
Dallas, Texas, United States
CRSTI/Medical City Dallas
Dallas, Texas, United States
Kingwood Medical Center Hospital
Kingwood, Texas, United States
Methodist Texsan Hospital
San Antonio, Texas, United States
Meriter Hospital, Inc.
Madison, Wisconsin, United States
CaRE Foundation, Inc.
Wausau, Wisconsin, United States
Countries
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References
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Cannon L, Kimmelstiel CD, Kellett M, White A, Hill R, Grady T, Myers PR, Underwood P, Dawkins KD. One-year real-world outcomes following implantation of the ION paclitaxel-eluting platinum chromium coronary stent in routine clinical practice: Primary endpoint results of the ION U.S. post-approval registry [abstract]. J Am Coll Cardiol. 2013; 62 (18 SUPPL. 1): B58
Kimmelstiel CD, Cannon LA, Jobe RL, Stoler R, Pow T, Ganim R, Kayser R, Allocco DJ, Dawkins KD. Two-Year "Real-World" Outcomes Following Implantation of the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent in Routine Clinical Practice: Results From the ION U.S. Post-Approval Registry. Presented at: The Transcatheter and Cardiovascular Therapeutics Annual Meeting 2014; Washington, D.C, USA. September 13 - 17, 2014.
Other Identifiers
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S2065
Identifier Type: -
Identifier Source: org_study_id
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