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

Status unconfirmed

Conditions studied: In-stent Coronary Artery Restenosis

In brief

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.

Key facts

Study ID

NCT01835301

Run by

Medstar Health Research Institute

People needed

40

Starts

2011-11-01

Last updated by the study team

2014-08-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States

Full record on ClinicalTrials.gov

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