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 |
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.
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
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