Coronary Artery Disease Clinical Trial
Official title:
A U.S. Post-Approval Study of the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System
| Verified date | January 2016 |
| Source | Boston Scientific Corporation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1120 |
| Est. completion date | February 2015 |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 110 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United States | King's Daughters Medical Center - Kentucky Heart Inst | Ashland | Kentucky |
| United States | Bakersfield Memorial Hospital | Bakersfield | California |
| United States | Union Memorial Hospital | Baltimore | Maryland |
| United States | Tufts Medical Center | Boston | Massachusetts |
| United States | Kootenai Medical Center | Coeur d'Alene | Idaho |
| United States | Sisters of Charity Providence Hospital | Columbia | South Carolina |
| United States | Ohio State University Medical Center | Columbus | Ohio |
| United States | Riverside Methodist Hospital | Columbus | Ohio |
| United States | Baylor Heart & Vascular Hospital | Dallas | Texas |
| United States | CRSTI/Medical City Dallas | Dallas | Texas |
| United States | Memorial Hospital at Gulfport | Gulfport | Mississippi |
| United States | Our Lady of Lourdes Medical Center | Haddon Heights | New Jersey |
| United States | Indiana Heart Hospital | Indianapolis | Indiana |
| United States | Krannert Institute of Cardiology | Indianapolis | Indiana |
| United States | Regional Hospital | Jackson | Tennessee |
| United States | NEA Baptist Memorial Hospital | Jonesboro | Arkansas |
| United States | St. Bernard's Medical Center | Jonesboro | Arkansas |
| United States | Freeman West Hospital | Joplin | Missouri |
| United States | Kingwood Medical Center Hospital | Kingwood | Texas |
| United States | Sparrow Health System - Sparrow Hospital | Lansing | Michigan |
| United States | St. Joseph's Hospital Health Center | Liverpool | New York |
| United States | Meriter Hospital, Inc. | Madison | Wisconsin |
| United States | Grand Strand Regional Medical Center | Myrtle Beach | South Carolina |
| United States | Centennial Medical Center | Nashville | Tennessee |
| United States | Oklahoma Heart Hospital | Oklahoma City | Oklahoma |
| United States | Northern Michigan Hospital | Petoskey | Michigan |
| United States | Maine Medical Center | Portland | Maine |
| United States | Wake Medical Center | Raleigh | North Carolina |
| United States | Redmond Regional Medical Center | Rome | Georgia |
| United States | Methodist Texsan Hospital | San Antonio | Texas |
| United States | Alvarado Hospital | San Diego | California |
| United States | Jersey Shore University Medical Center | Sea Girt | New Jersey |
| United States | Lakeland Hospitals at St. Joseph | St. Joseph | Michigan |
| United States | Northside Hospital and Heart Institute | St. Petersburg | Florida |
| United States | University Community Hospital | Tampa | Florida |
| United States | Mercy St. Vincent Medical Center | Toledo | Ohio |
| United States | St. Elizabeth Medical Center | Utica | New York |
| United States | CaRE Foundation, Inc. | Wausau | Wisconsin |
| United States | Iowa Heart Center | West Des Moines | Iowa |
| United States | St. Mary Medical Center | Yardley | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Boston Scientific Corporation |
United States,
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 endp
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 Fro
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Cardiac Death or Myocardial Infarction (CD/MI) | Cardiac Death or myocardial infarction (CD/MI) in the ION registry population. For the protocol specified primary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations. | 12 Months | Yes |
| Secondary | Stent Thrombosis | Academic Research Consortium (ARC) defined (definite/probable) stent thrombosis (ST) in the ION registry population. For the protocol specified secondary endpoint analysis including data pooled from the PERSEUS SV, PERSEUS WH and TE Prove patient populations please see the citations. | Annually, after the first year, through 2 years. | Yes |
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