Coronary Artery DiseaseNCT00487604
Retrospective Study of the Impact of Drug Eluting Stents
An observational study of Coronary Artery Disease, run by Providence Health & Services at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the use of drug eluting stents is associated with higher rates of death, myocardial infarction, and major bleeding. In addition, the overall economic costs of implanting drug eluting stents compared to bare metal stents will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 9,800 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to May 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coronary artery stenting between March 1, 2001 and March 30, 2006
Who cannot join
- Implanted investigational drug eluting stents
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Sacred Heart Medical Center
Spokane, Washington, 99204
Sandra J. Albritton, RN, MN, 509-474-4345, salbritt@this.org
Lynn A. Shuler, RN, MA, 509.474.4302, lshuler@this.org
About this study
Official title: Retrospective Study of the Impact of Drug Eluting Stents on Intermediate Term Survival, Cardiovascular Outcomes Including Revascularization, Bleeding Rates and Economic Costs
The purpose of this study is to determine whether the use of drug eluting stents is associated with higher rates of death, myocardial infarction, and major bleeding. In addition, the overall economic costs of implanting drug eluting stents compared to bare metal stents will be assessed.
Read the detailed description
A major limitation of percutaneous coronary stenting compared to coronary artery bypass grafting surgery has been the significantly higher need for repeat revascularization due to restenosis occurring at or near the stent site. By eluting a potent anti-proliferative agent from a polymer coated stent in a time-controlled manner, it has been possible to markedly inhibit intimal proliferation that results from implantation of a bare metal stent, dramatically reducing the need for future target lesion revascularization.
Recent angioscopic and autopsy studies have demonstrated markedly delayed and incomplete endothelialization following drug-eluting stent implantation. These events are rarely observed following bare metal stent implantation. In addition, drug-eluting stents have been associated with hypersensitivity reactions, which may predispose patients to subacute thrombosis. Finally, serial intra-coronary ultrasound studies demonstrate late stent mal-apposition, which is believed to create a possible nidus for thrombus formation.
By means of examining several extensive administrative databases, this study will retrospectively examine approximately 9,800 consecutive patients who underwent either bare metal or drug eluting coronary artery stenting at Sacred Heart Medical Center, Spokane, WA between March 1, 2001 and March 30, 2006. Time frame of follow-up is at least 18 months.
Comparison: The strategy of implanting stents during three time periods will be compared to each other. In the first study period which occurred prior to commercial release of the Cypher drug eluting stent, all patients received bare metal stents. The second study group will include all patients from the time frame between release of the Cypher stent and the Taxus drug eluting stent (approximately one year) after which a contractual decision was made to only utilize Taxus stents. During second time frame of corresponding to availability of the Cypher stent, about 30% of total stent cases received drug eluting stents predominately for "on label" indications. The third study group occurred during a time-frame when Taxus drug eluting stents were implanted in about 90% of overall patients including many with "off label" indications.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Drug Eluting Stent, Bare Metal Stent, Subacute thrombosis, Bleeding, Economic
- Medical subject headings
- Coronary Artery Disease, Hemorrhage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2007 (estimated)
- Study startMay 2007
- Study completionMay 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Defined population
- Time perspective
- Retrospective
- Enrolment
- 9,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Providence Health & Services
- Sponsor type
- University, hospital or other
- Investigators
- Michael E. Ring, MD, Principal investigator, Providence Health & Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487604
- Sponsor's protocol ID
- PMRC1371
- Status last verified
- Apr 2007
- First submitted
- 14 Jun 2007
- Last updated
- 2 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of the Impact of Drug Eluting Stents on Intermediate Term Survival, Cardiovascular Outcomes Including Revascularization, Bleeding Rates and Economic Costs
- ClinicalTrials.gov ID
- NCT00487604
- Acronym / sponsor ID
- PMRC1371
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Drug Eluting Stent, Bare Metal Stent, Subacute thrombosis, Bleeding, Economic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9,800 participants (estimated)
- Lead sponsor
- Providence Health & ServicesUniversity, hospital or other
- Study start
- May 2007
- Study completion
- May 2008 (estimated)
- First posted
- 18 Jun 2007 (estimated)
- Results
- Not posted in the source record
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 determine whether the use of drug eluting stents is associated with higher rates of death, myocardial infarction, and major bleeding. In addition, the overall economic costs of implanting drug eluting stents compared to bare metal stents will be assessed.
Detailed description
A major limitation of percutaneous coronary stenting compared to coronary artery bypass grafting surgery has been the significantly higher need for repeat revascularization due to restenosis occurring at or near the stent site. By eluting a potent anti-proliferative agent from a polymer coated stent in a time-controlled manner, it has been possible to markedly inhibit intimal proliferation that results from implantation of a bare metal stent, dramatically reducing the need for future target lesion revascularization.
Recent angioscopic and autopsy studies have demonstrated markedly delayed and incomplete endothelialization following drug-eluting stent implantation. These events are rarely observed following bare metal stent implantation. In addition, drug-eluting stents have been associated with hypersensitivity reactions, which may predispose patients to subacute thrombosis. Finally, serial intra-coronary ultrasound studies demonstrate late stent mal-apposition, which is believed to create a possible nidus for thrombus formation.
By means of examining several extensive administrative databases, this study will retrospectively examine approximately 9,800 consecutive patients who underwent either bare metal or drug eluting coronary artery stenting at Sacred Heart Medical Center, Spokane, WA between March 1, 2001 and March 30, 2006. Time frame of follow-up is at least 18 months.
Comparison: The strategy of implanting stents during three time periods will be compared to each other. In the first study period which occurred prior to commercial release of the Cypher drug eluting stent, all patients received bare metal stents. The second study group will include all patients from the time frame between release of the Cypher stent and the Taxus drug eluting stent (approximately one year) after which a contractual decision was made to only utilize Taxus stents. During second time frame of corresponding to availability of the Cypher stent, about 30% of total stent cases received drug eluting stents predominately for "on label" indications. The third study group occurred during a time-frame when Taxus drug eluting stents were implanted in about 90% of overall patients including many with "off label" indications.
Study design
- Observational model
- Defined population
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Coronary artery stenting between March 1, 2001 and March 30, 2006
Key exclusion criteria (1 listed)
- Implanted investigational drug eluting stents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2007.
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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.
Michael E. Ring, MD principal investigator
Providence Health & Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Providence Health & Services at 1 site 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: status not confirmed, as of the sponsor's last update on 2 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lynn A. Shuler, RN, MA (509.474.4302, lshuler@this.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 2 Aug 2007.