Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:5/5/2014
Start Date:November 2011

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This study aims to test the hypothesis that plaque composition differs within a stent
between bare metal stents and drug eluting stents (DES). It is possible that a difference in
plaque composition seen within a stent may be contributory to the late thrombotic events
seen more frequently with DES.


Inclusion Criteria:

- Subject > 18 years of age;

- Subject, male or female, who underwent DES or BMS implantation in a native coronary
vessel more than 3 year ago;

- Subject is scheduled for a diagnostic coronary or interventional procedure;

- Subject is willing to sign the informed consent.

Exclusion Criteria:

- Subject requires emergency catheterization;

- Subject has an acute myocardial infarction defined as anginal symptoms with
ST-elevation on the EKG or creatine kinase-MB elevation >3times the upper limit of
normal;

- Angiographic evidence of ≥ 70% stenosis within the target stent (visual estimate);

- Subject presented with cardiogenic shock;

- Subject has angiographically confirmed thrombus in the target coronary artery;

- Subject has a complex lesion not amenable to the IVUS/VH catheters and/or OCT
catheters passing the stented segment;

- Subject has a contraindication to angiography/IVUS/OCT;

- Female subject is pregnant or lactating;

- Subject has life threatening comorbid conditions for which the investigator feels the
subject should not be enrolled
We found this trial at
1
site
Washington, District of Columbia
?
mi
from
Washington,
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