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ION US Post-Approval Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01422889
Recruitment Status : Completed
First Posted : August 25, 2011
Results First Posted : March 20, 2015
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Study Description
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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.

Condition or disease Intervention/treatment
Atherosclerosis Coronary Artery Disease Device: ION™ Coronary Stent System

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.
Study Design
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Study Type : Observational
Actual Enrollment : 1120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A U.S. Post-Approval Study of the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System
Study Start Date : September 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Atherosclerosis

Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 Device: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Cardiac Death or Myocardial Infarction (CD/MI) [ Time Frame: 12 Months ]
    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.


Secondary Outcome Measures :
  1. Stent Thrombosis [ Time Frame: Annually, after the first year, through 2 years. ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01422889


Locations
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Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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Principal Investigator: Louis A Cannon, MD Northern Michigan Hospital
Principal Investigator: Carey D Kimmelstiel, MD Tufts Medical Center
More Information
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Publications of Results:
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.

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01422889    
Other Study ID Numbers: S2065
First Posted: August 25, 2011    Key Record Dates
Results First Posted: March 20, 2015
Last Update Posted: February 4, 2016
Last Verified: January 2016
Keywords provided by Boston Scientific Corporation:
Atherosclerosis
Coronary Artery Disease
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Atherosclerosis
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases