Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation
This trial is active, not recruiting.
|Condition||in-stent coronary artery restenosis|
|Sponsor||Medstar Research Institute|
|Start date||November 2011|
|End date||December 2015|
|Trial size||40 participants|
|Trial identifier||NCT01835301, IntraStent|
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.
Patients who received a DES stent > 3 years ago.
Patients who received BMS stents > 3 years ago.
time frame: During hospital stay, about 2 days.
Male or female participants at least 18 years old.
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
|Official title||Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation|
|Principal investigator||Ron Waksman, MD|
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