Clinical trial NCT01422889: ION US Post-Approval Study
Official title: A U.S. Post-Approval Study of the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atherosclerosis
Coronary Artery Disease
Keywords: Atherosclerosis
Coronary Artery Disease
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2011-08-25
Enrollment: 1120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consented subjects admitted to the cardiac catheterization laboratory for percutaneous transluminal coronary angioplasty and who are eligible to receive an ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent.

Brief summary: The purpose of this study is to compile real-world clinical outcomes data for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System in routine clinical practice.

Detailed description: The ION™ stent is the third-generation Boston Scientific (BSC) paclitaxel-eluting coronary stent. It is designed for improved performance specific to deliverability and radio-opacity while maintaining a similar drug release profile of the TAXUS Express and TAXUS Liberté stents. Following PMA approval from the FDA for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System the ION US Post-Approval study will compile real-world clinical outcomes data for the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System in routine clinical practice. Post-approval studies of drug-eluting stents (DES) provide an opportunity to observe and assess patient outcomes and technology performance in a real-world setting.

Eligibility criteria: Inclusion Criteria:

Consented subjects receiving one or more ION(TM)Coronary Stents

Exclusion Criteria:

Subjects not clinically indicated to receive an ION (TM)Coronary Stent

Primary outcomes:
measure: Cardiac Death or Myocardial Infarction (CD/MI)
timeFrame: 12 Months
Secondary outcomes:
measure: Stent Thrombosis
timeFrame: Annually, after the first year, through 2 years.
Other outcomes:
Locations:
city: Jonesboro
country: United States
facility: NEA Baptist Memorial Hospital
state: Arkansas
city: Jonesboro
country: United States
facility: St. Bernard's Medical Center
state: Arkansas
city: Bakersfield
country: United States
facility: Bakersfield Memorial Hospital
state: California
city: San Diego
country: United States
facility: Alvarado Hospital
state: California
city: St. Petersburg
country: United States
facility: Northside Hospital and Heart Institute
state: Florida
city: Tampa
country: United States
facility: University Community Hospital
state: Florida
city: Rome
country: United States
facility: Redmond Regional Medical Center
state: Georgia
city: Coeur d'Alene
country: United States
facility: Kootenai Medical Center
state: Idaho
city: Indianapolis
country: United States
facility: Krannert Institute of Cardiology
state: Indiana
city: Indianapolis
country: United States
facility: Indiana Heart Hospital
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Ashland
country: United States
facility: King's Daughters Medical Center - Kentucky Heart Inst
state: Kentucky
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: Union Memorial Hospital
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Lansing
country: United States
facility: Sparrow Health System - Sparrow Hospital
state: Michigan
city: Petoskey
country: United States
facility: Northern Michigan Hospital
state: Michigan
city: St. Joseph
country: United States
facility: Lakeland Hospitals at St. Joseph
state: Michigan
city: Gulfport
country: United States
facility: Memorial Hospital at Gulfport
state: Mississippi
city: Joplin
country: United States
facility: Freeman West Hospital
state: Missouri
city: Haddon Heights
country: United States
facility: Our Lady of Lourdes Medical Center
state: New Jersey
city: Sea Girt
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Liverpool
country: United States
facility: St. Joseph's Hospital Health Center
state: New York
city: Utica
country: United States
facility: St. Elizabeth Medical Center
state: New York
city: Raleigh
country: United States
facility: Wake Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Toledo
country: United States
facility: Mercy St. Vincent Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital
state: Oklahoma
city: Yardley
country: United States
facility: St. Mary Medical Center
state: Pennsylvania
city: Columbia
country: United States
facility: Sisters of Charity Providence Hospital
state: South Carolina
city: Myrtle Beach
country: United States
facility: Grand Strand Regional Medical Center
state: South Carolina
city: Jackson
country: United States
facility: Regional Hospital
state: Tennessee
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Baylor Heart & Vascular Hospital
state: Texas
city: Dallas
country: United States
facility: CRSTI/Medical City Dallas
state: Texas
city: Kingwood
country: United States
facility: Kingwood Medical Center Hospital
state: Texas
city: San Antonio
country: United States
facility: Methodist Texsan Hospital
state: Texas
city: Madison
country: United States
facility: Meriter Hospital, Inc.
state: Wisconsin
city: Wausau
country: United States
facility: CaRE Foundation, Inc.
state: Wisconsin
Study officials:
affiliation: Northern Michigan Hospital
name: Louis A Cannon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tufts Medical Center
name: Carey D Kimmelstiel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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
citation: 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.