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Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation | Clinical Trials | Clareo Health

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

NCT01835301•Medstar Health Research Institute

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Medstar Washington Hospital Center

Washington D.C., District of Columbia, United States

Key Dates

Start Date

November 1, 2011

Primary Completion Date

December 1, 2015

Last Updated

August 11, 2014

Enrollment

ESTIMATED participants

Conditions

In-stent Coronary Artery Restenosis