ION US Post-Approval Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01422889
First received: August 22, 2011
Last updated: March 9, 2015
Last verified: March 2015
  Purpose

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 Intervention
Atherosclerosis
Coronary Artery Disease
Device: ION™ Coronary Stent System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A U.S. Post-Approval Study of the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Cardiac Death or Myocardial Infarction (CD/MI) [ Time Frame: 12 Months ] [ Designated as safety issue: Yes ]
    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:
  • Stent Thrombosis [ Time Frame: Annually, after the first year, through 2 years. ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 1120
Study Start Date: September 2011
Study Completion Date: February 2015
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01422889

  Show 40 Study Locations
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
Principal Investigator: Louis A Cannon, MD Northern Michigan Hospital
Principal Investigator: Carey D Kimmelstiel, MD Tufts Medical Center
  More Information

No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01422889     History of Changes
Other Study ID Numbers: S2065
Study First Received: August 22, 2011
Results First Received: April 23, 2014
Last Updated: March 9, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Boston Scientific Corporation:
Atherosclerosis
Coronary Artery Disease

Additional relevant MeSH terms:
Atherosclerosis
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on March 30, 2015