AtherosclerosisNCT01422889
ION US Post-Approval Study
An observational study of Atherosclerosis and Coronary Artery Disease, run by Boston Scientific Corporation at 40 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Atherosclerosis, Coronary Artery Disease
- What is being tested?
- ION™ Coronary Stent System
- Type of treatment
- Medical device
- How many people
- 1,120 participants
- Where
- 40 sitesUnited States
- Study dates
- Sep 2011to Feb 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Consented subjects receiving one or more ION(TM)Coronary Stents
Who cannot join
- Subjects not clinically indicated to receive an ION (TM)Coronary Stent
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
King's Daughters Medical Center - Kentucky Heart Inst
Ashland, Kentucky, 41101
Bakersfield Memorial Hospital
Bakersfield, California, 93301
Union Memorial Hospital
Baltimore, Maryland, 21218
Tufts Medical Center
Boston, Massachusetts, 02111
Kootenai Medical Center
Coeur d'Alene, Idaho, 83814
Sisters of Charity Providence Hospital
Columbia, South Carolina, 29204
Ohio State University Medical Center
Columbus, Ohio, 43210
Riverside Methodist Hospital
Columbus, Ohio, 43214
Baylor Heart & Vascular Hospital
Dallas, Texas, 75226
CRSTI/Medical City Dallas
Dallas, Texas, 75230
Memorial Hospital at Gulfport
Gulfport, Mississippi, 39501
Our Lady of Lourdes Medical Center
Haddon Heights, New Jersey, 08035
Krannert Institute of Cardiology
Indianapolis, Indiana, 46202
Indiana Heart Hospital
Indianapolis, Indiana, 46250
Regional Hospital
Jackson, Tennessee, 38305
NEA Baptist Memorial Hospital
Jonesboro, Arkansas, 72401
St. Bernard's Medical Center
Jonesboro, Arkansas, 72401
Freeman West Hospital
Joplin, Missouri, 64804
Kingwood Medical Center Hospital
Kingwood, Texas, 77339
Sparrow Health System - Sparrow Hospital
Lansing, Michigan, 48910
St. Joseph's Hospital Health Center
Liverpool, New York, 13088
Meriter Hospital, Inc.
Madison, Wisconsin, 53713
Grand Strand Regional Medical Center
Myrtle Beach, South Carolina, 29572
Centennial Medical Center
Nashville, Tennessee, 37203
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, 73120
Northern Michigan Hospital
Petoskey, Michigan, 49770
Maine Medical Center
Portland, Maine, 04102
Wake Medical Center
Raleigh, North Carolina, 27610
Redmond Regional Medical Center
Rome, Georgia, 30165
Lakeland Hospitals at St. Joseph
Saint Joseph, Michigan, 49085
Methodist Texsan Hospital
San Antonio, Texas, 78201
Alvarado Hospital
San Diego, California, 92121
Jersey Shore University Medical Center
Sea Girt, New Jersey, 08750
Northside Hospital and Heart Institute
St. Petersburg, Florida, 33709
University Community Hospital
Tampa, Florida, 33613
Mercy St. Vincent Medical Center
Toledo, Ohio, 43608
St. Elizabeth Medical Center
Utica, New York, 13501
CaRE Foundation, Inc.
Wausau, Wisconsin, 54401
Iowa Heart Center
West Des Moines, Iowa, 50266
St. Mary Medical Center
Yardley, Pennsylvania, 19067
About this study
Official title: A U.S. Post-Approval Study of the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System
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.
Read the 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.
- Conditions
- Atherosclerosis, Coronary Artery Disease
- Being tested
- ION™ Coronary Stent System
- Keywords
- Atherosclerosis, Coronary Artery Disease
- Medical subject headings
- Atherosclerosis, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ION™ Coronary Stent SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: ION™ Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 Months
Secondary outcomes (1)
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.
Measured: Annually, after the first year, through 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2013
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Louis A Cannon, MD, Principal investigator, Northern Michigan HospitalCarey D Kimmelstiel, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422889
- Sponsor's protocol ID
- S2065
- Status last verified
- Jan 2016
- First submitted
- 22 Aug 2011
- Last updated
- 4 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A U.S. Post-Approval Study of the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System
- ClinicalTrials.gov ID
- NCT01422889
- Acronym / sponsor ID
- S2065
- Conditions
- Atherosclerosis, Coronary Artery Disease
- Keywords
- Atherosclerosis, Coronary Artery Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,120 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 25 Aug 2011 (estimated)
- Results
- Posted 20 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ION Registry | – | Device: ION™ Coronary Stent SystemThe 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. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Consented subjects receiving one or more ION(TM)Coronary Stents
Key exclusion criteria (1 listed)
- Subjects not clinically indicated to receive an ION (TM)Coronary Stent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ION™ Coronary Stent SystemThis 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. | Device | ION Registry |
Primary outcome
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.
1 secondary outcome
Stent Thrombosis
Time frame: Annually, after the first year, through 2 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationCannon 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
- Results publicationKimmelstiel 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis A Cannon, MD principal investigator
Northern Michigan Hospital
Carey D Kimmelstiel, MD principal investigator
Tufts Medical Center
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis and Coronary Artery Disease, run by Boston Scientific Corporation at 40 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Death or Myocardial Infarction (CD/MI) (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01422889, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016; AzTrials last refreshed its copy on 28 Oct 2026.