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

• Conditions: In-stent Coronary Artery Restenosis

• Registration Number: NCT01835301
• Lead Sponsor: Medstar Health Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2013-04-12
• Study First Submitted QC: 2013-04-16
• Study First Posted: 2013-04-18
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-08
• Last Update Posted: 2014-08-11
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Plaque composition	During hospital stay, about 2 days.	This study aims to test the hypothesis that plaque composition differs within the stent between BMS and DES. It is possible that a difference in plaque composition seen within the stent may be contributory to the late thrombotic events seen more frequently with DES.

Trial Locations

Locations (1)

Medstar Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States