Status:
UNKNOWN
Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation
Lead Sponsor:
Medstar Health Research Institute
Conditions:
In-stent Coronary Artery Restenosis
Eligibility:
All Genders
18+ years
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 se...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01835301
Start Date
November 1 2011
Last Update
August 11 2014
Active Locations (1)
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1
Medstar Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010