Intravascular Optical Coherence Tomography Imaging - Length of Anti-Platelet Therapy After Drug Eluting Stent Placement

NCT01219894 | Withdrawn DMC

• 1 other identifier: IRB00045456
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Coronary Disease; Stent; Healing; Anti-platelet therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• death

  1 year

• Stent Thrombosis

  1 year

• myocardial infarction

  1 year

• Bleeding

  1 year

Study Arms (2)

RUTTS Score <30%

Patients with evidence of complete healing of stent at 3 months

RUTTS<30%

Group with evidence of incomplete healing of the stent

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with a single DES (EndeavorTM, zotarolimus, Medtronic Vascular) will be enrolled in this study.

You may qualify if:

• Any patient requiring percutaneous coronary intervention and meeting criteria (as determined by the performing physician) for Endeavor Drug Eluting Stent Placement

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emory University: lead
• Medtronic Vascular: collaborator
• Light Lab Imaging, Inc.: collaborator
• Abbott Medical Devices: collaborator

Related Publications (2)

• 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. doi: 10.1161/CIRCULATIONAHA.107.693739. Epub 2007 Apr 16.

  PMID: 17438147 BACKGROUND

• 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.

  PMID: 20129551 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Aloke Finn, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: October 13, 2010
• Study Start: November 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 20, 2013

Record last verified: 2013-11