Coronary Artery Disease Clinical Trial
— FDI-DAPT-ZESOfficial title:
Frequency Domain Imaging to Determine Stent Strut Coverage and Duration of Anti-Platelet Treatment After Endeavor Stent Placement
Verified date | November 2013 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
Patients who receive drug-coated stents (as opposed to the less frequently used bare metal
stents) are currently recommended aspirin plus a thienopyridine such as Plavix, Effient, or
Ticlid for one year. These guidelines apply to all patients with drug-coated stents,
regardless of the type of stent they received. The purpose of these medications is to
prevent a clot at the stent site when there is poor healing of artery tissues over the
stent. A clot is a serious concern because it can suddenly block blood flow to the heart and
cause a heart attack. These medications have been proven to be helpful in stent patients,
but they do have risks. The common side-effects are related to bleeding which in a few
patients can be serious. A patient may be at risk for forming a clot if they must put these
medications on hold for a surgical procedure to reduce the risk of bleeding. Plavix and
Effient are also expensive for patients who are underinsured or uninsured. There is interest
is finding a way to show that a patient's stent has healed properly before 12 months and
that they can safely stop these medications early.
This study is looking at a way to determine if patients who receive the Endeavor drug-coated
stent and who are prescribed aspirin and Plavix can safely stop Plavix at 3 months instead
of 12. Previous studies have shown 99.9% coverage of the body's own tissues on an Endeavor
stent after 3 months.
A device called an Optical Coherence Tomography (OCT) catheter will be used in this study to
look at how much a stent has healed. It allows imaging inside a heart artery and the ability
to see the healing of tissues over the stent.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 80 Years |
Eligibility |
Inclusion Criteria: - Any patient requiring percutaneous coronary intervention and meeting criteria (as determined by the performing physician) for Endeavor Drug Eluting Stent Placement Exclusion Criteria: - Patients requiring >1 stent per treated lesion - ST segment elevation MI (STEMI) - inability to comply with study follow-up including 12 months of DAPT - current or planned pregnancy (for women of childbearing age) |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Emory University | Light Lab Imaging, Inc., Medtronic Vascular, St. Jude Medical |
Finn AV, Joner M, Nakazawa G, Kolodgie F, Newell J, John MC, Gold HK, Virmani R. Pathological correlates of late drug-eluting stent thrombosis: strut coverage as a marker of endothelialization. Circulation. 2007 May 8;115(18):2435-41. Epub 2007 Apr 16. — View Citation
Kim JS, Jang IK, Fan C, Kim TH, Kim JS, Park SM, Choi EY, Lee SH, Ko YG, Choi D, Hong MK, Jang Y. Evaluation in 3 months duration of neointimal coverage after zotarolimus-eluting stent implantation by optical coherence tomography: the ENDEAVOR OCT trial. JACC Cardiovasc Interv. 2009 Dec;2(12):1240-7. doi: 10.1016/j.jcin.2009.10.006. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of =30% of the target stent as determined by OCT pullback of the target stent | Primary Endpoint: The primary endpoint of this trial will be the frequency of near complete healing 3 months after Endeavor placement defined as a Ratio of Uncovered to Total Stent Struts Per Cross Section (RUTTS) score of =30%. | 3 months | No |
Secondary | death | Occurrence of events after 3-month follow-up in the group with OCT guided early discontinuation of DAPT versus those adhering to standard of care (i.e. 12 months of DAPT). Events will be defined as death, stent thrombosis (Academic Research Consortium definition), myocardial infarction (defined as any evidence of troponin elevation above the upper limit of normal), and bleeding (TIMI Bleeding Classification (table 1)). We will also examine the relationship between underlying plaque morphology and 3 month follow-up OCT determined strut coverage. | 1 year | No |
Secondary | Stent Thrombosis | As defined by the Academic Research Consortium definition. | 1 year | No |
Secondary | myocardial infarction | Defined as any troponin elevation above the upper limit of normal | 1 year | No |
Secondary | Bleeding | As defined by the TIMI Bleeding Classification. | 1 year | No |
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