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

Launched by MEDSTAR HEALTH RESEARCH INSTITUTE · Apr 16, 2013

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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