Percutaneous Coronary InterventionNCT00937573
Xience V at Wake Forest University Baptist Medical Center (WFUBMC)
An observational study of Percutaneous Coronary Intervention and Stents, run by Wake Forest University at 1 site in United States.
Trial summary
The effectiveness, safety, and deliverability of second generation drug eluting stents (DES), including Xience V, will need to be examined in real world patients to provide the same level of evidence base and comfort that has accompanied the use of the first generation devices. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Percutaneous Coronary Intervention, Stents
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Aug 2013
- 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
Study population: Adults with coronary artery disease seen at WFUBMC cardiac catheterization laboratory who received percutaneous coronary intervention with placement of one or more stents
Who may be able to join
- percutaneous coronary intervention with stenting
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University School of Medicine
Winston-Salem, North Carolina, 27517
About this study
Official title: Xience V at WFUBMC: Real World Outcomes Using Second Generation DES
The effectiveness, safety, and deliverability of second generation drug eluting stents (DES), including Xience V, will need to be examined in real world patients to provide the same level of evidence base and comfort that has accompanied the use of the first generation devices. Randomized clinical trials provide the fairest evaluation of outcomes by controlling for confounding patient and procedural characteristics; however, randomized clinical trials also exclude the very high risk patients that account for upwards of 80% of real world patient populations such as those at Wake Forest University Baptist Medical Center (WFUBMC).
Clinical follow-up data including non-fatal MI, all cause mortality and stent thrombosis, as well as medications compliance, of patients undergoing stent therapy including Xience V in a real world patient population will be collected at WFUBMC. Existing data for several control groups will be used to compare outcomes with Xience V including a consecutively treated bare metal stent (BMS) cohort of 1,200 patients, and a DES cohort of 1,200 patients (900 sirolimus-eluting and 300 paclitaxel-eluting) treated between April 2004 and April 2005. Patients undergoing stent therapy in the year prior to use of Xience V, and contemporaneous patients receiving non-Xience V stent therapy during Xience V use will serve as additional controls. All patient data will be de-identified using unique blinded identification codes after data collection is completed.
The null hypothesis of this study states that safety outcomes (stent thrombosis, non-fatal MI, death) with Xience V will be equivalent to historical and contemporaneous controls; effectiveness outcomes (target lesion and target vessel revascularization) with Xience V will be superior to historical and contemporaneous BMS controls, and equivalent to historical and contemporaneous DES controls; and the need for crossover to another stent type will be equal to that observed with historical DES controls. Outcomes will be reported using contemporary measures of clinical outcomes and analyzed using Cox proportional hazards survival analysis methodology. These data should provide important information on the clinical effectiveness and safety of Xience V in routine practice.
- Conditions
- Percutaneous Coronary Intervention, Stents
- Keywords
- stents, mortality, revascularization, stent thrombosis, Drug-Eluting Stents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Xience V | Percutaneous coronary intervention with Xience V stent placement | |
| Historical BMS | Percutaneous coronary intervention with bare metal stent placement prior to availability of Cypher, Taxus, or Xience V drug eluting stents at WFUBMC | |
| Historical DES | Percutaneous coronary intervention with drug eluting stent placement prior to availability of Xience V drug eluting stents at WFUBMC | |
| Contemporary BMS | Percutaneous coronary intervention with bare metal stent placement after Xience V drug eluting stents were available for use at WFUBMC | |
| Contemporary DES | Percutaneous coronary intervention with Cypher or Taxus drug eluting stent placement after Xience V drug eluting stents were available for use at WFUBMC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of non-fatal myocardial infarction, death, or stent thrombosis
Measured: Annual landmark
Secondary outcomes (1)
Target lesion/vessel revascularization
Measured: Annual landmark
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Sponsor
- Investigators
- Robert J Applegate, MD, Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00937573
- Sponsor's protocol ID
- ACS-6814
- Status last verified
- Dec 2014
- First submitted
- 10 Jul 2009
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xience V at WFUBMC: Real World Outcomes Using Second Generation DES
- ClinicalTrials.gov ID
- NCT00937573
- Acronym / sponsor ID
- ACS-6814
- Conditions
- Percutaneous Coronary Intervention, Stents
- Keywords
- stents, mortality, revascularization, stent thrombosis, Drug-Eluting Stents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Wake Forest UniversityUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Jul 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 13 Jul 2009 (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 effectiveness, safety, and deliverability of second generation drug eluting stents (DES), including Xience V, will need to be examined in real world patients to provide the same level of evidence base and comfort that has accompanied the use of the first generation devices. Randomized clinical trials provide the fairest evaluation of outcomes by controlling for confounding patient and procedural characteristics; however, randomized clinical trials also exclude the very high risk patients that account for upwards of 80% of real world patient populations such as those at Wake Forest University Baptist Medical Center (WFUBMC).
Clinical follow-up data including non-fatal MI, all cause mortality and stent thrombosis, as well as medications compliance, of patients undergoing stent therapy including Xience V in a real world patient population will be collected at WFUBMC. Existing data for several control groups will be used to compare outcomes with Xience V including a consecutively treated bare metal stent (BMS) cohort of 1,200 patients, and a DES cohort of 1,200 patients (900 sirolimus-eluting and 300 paclitaxel-eluting) treated between April 2004 and April 2005. Patients undergoing stent therapy in the year prior to use of Xience V, and contemporaneous patients receiving non-Xience V stent therapy during Xience V use will serve as additional controls. All patient data will be de-identified using unique blinded identification codes after data collection is completed.
The null hypothesis of this study states that safety outcomes (stent thrombosis, non-fatal MI, death) with Xience V will be equivalent to historical and contemporaneous controls; effectiveness outcomes (target lesion and target vessel revascularization) with Xience V will be superior to historical and contemporaneous BMS controls, and equivalent to historical and contemporaneous DES controls; and the need for crossover to another stent type will be equal to that observed with historical DES controls. Outcomes will be reported using contemporary measures of clinical outcomes and analyzed using Cox proportional hazards survival analysis methodology. These data should provide important information on the clinical effectiveness and safety of Xience V in routine practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Xience V | – | –Percutaneous coronary intervention with Xience V stent placement |
| Historical BMS | – | –Percutaneous coronary intervention with bare metal stent placement prior to availability of Cypher, Taxus, or Xience V drug eluting stents at WFUBMC |
| Historical DES | – | –Percutaneous coronary intervention with drug eluting stent placement prior to availability of Xience V drug eluting stents at WFUBMC |
| Contemporary BMS | – | –Percutaneous coronary intervention with bare metal stent placement after Xience V drug eluting stents were available for use at WFUBMC |
| Contemporary DES | – | –Percutaneous coronary intervention with Cypher or Taxus drug eluting stent placement after Xience V drug eluting stents were available for use at WFUBMC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with coronary artery disease seen at WFUBMC cardiac catheterization laboratory who received percutaneous coronary intervention with placement of one or more stents
Key inclusion criteria (1 listed)
- percutaneous coronary intervention with stenting
Key exclusion criteria (1 listed)
- none
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
Composite of non-fatal myocardial infarction, death, or stent thrombosis
Time frame: Annual landmark
1 secondary outcome
Target lesion/vessel revascularization
Time frame: Annual landmark
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
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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.
Robert J Applegate, MD principal investigator
Wake Forest University
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 Percutaneous Coronary Intervention and Stents, run by Wake Forest University 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: finished, as of the sponsor's last update on 6 Nov 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Composite of non-fatal myocardial infarction, death, or stent thrombosis (time frame: Annual landmark). It is what the study was designed to measure, not a finding.
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 6 Nov 2017.