Atherosclerosis, Coronary Artery Disease
Conditions
Keywords
Atherosclerosis, Coronary Artery Disease
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.
Interventions
DEVICEION™ 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.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Death or Myocardial Infarction (CD/MI) | 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
| Measure | Time frame | Description |
|---|---|---|
| Stent Thrombosis | 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. |
Countries
United States
Participant flow
Recruitment details
Subject recruitment began on 19 September 2011 and was completed on 24 April 2012.
Participants by arm
| Arm | Count |
|---|---|
| ION Registry The ION Registry population contains 1120 enrolled subjects with 1111 eligible for analysis. Subjects eligible for analysis includes subjects with at least one study stent implanted. | 1,111 |
| Total | 1,111 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | No Data Entered for Study Stent | 9 |
Baseline characteristics
| Characteristic | ION Registry |
|---|---|
| Age, Continuous | 64.1 years STANDARD_DEVIATION 10.98 |
| Cardiac Risk Factors Current Smoker | 275 participants |
| Cardiac Risk Factors Diabetes | 376 participants |
| Cardiac Risk Factors Hyperlipidemia | 869 participants |
| Cardiac Risk Factors Hypertension | 905 participants |
| Cardiac Risk Factors Prior PCI | 522 participants |
| Cardiac Risk Factors Unstable Angina | 485 participants |
| Lesion Characteristics Bifurcation | 116 participants |
| Lesion Characteristics Long Lesions (>=28mm) | 235 participants |
| Lesion Characteristics RVD<=2.5mm | 387 participants |
| Lesion Characteristics:Lesion Based Culprit for STEMI | 108 Lesions |
| Lesion Characteristics:Lesion Based Severe Calcification | 79 Lesions |
| Region of Enrollment United States | 1111 participants |
| Sex: Female, Male Female | 330 Participants |
| Sex: Female, Male Male | 781 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,111 |
| serious Total, serious adverse events | 324 / 1,111 |
Outcome results
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.
Time frame: 12 Months
Population: There were 83 subjects not evaluable for 12-month cardiac events (No follow-up ≥ 335 days and events-free within 365-day) leaving a total of 1028 subjects evaluated for 12 month CD/MI.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ION Registry | Cardiac Death or Myocardial Infarction (CD/MI) | 2.2 percentage of paricipants |
Comparison: 2.2% (23/1028) of ION Registry subjects experienced CD/MI related to the ION stent at 12 months
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.
Time frame: Annually, after the first year, through 2 years.
Population: There were 57 subjects not evaluable for 2-year cardiac events (No follow-up ≥ 700 days and events-free within 730-day) leaving a total of 1054 subjects evaluated for ARC ST Definite/Probable.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ION Registry | Stent Thrombosis | 2.6 percentage of participants |
Comparison: 2.6% (27/1054) of ION Registry subjects experienced ARC ST Definite/Probable related to the ION stent at 2 years.