ClinicalTrials.gov processed this data on March 28, 2024Link to the current ClinicalTrials.gov record.https://clinicaltrials.gov/ct2/show/NCT01835301IntraStentNCT01835301Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since ImplantationIntra-stent Tissue Evaluation Within BMS and DES > 3 Years Since ImplantationMedstar Health Research InstituteOtherNo
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.
Unknown statusActive, not recruitingNovember 2011December 2015ObservationalNoCohortProspectivePlaque compositionDuring 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.240In-stent Coronary Artery RestenosisDESPatients who received a DES stent > 3 years ago.BMSPatients who received BMS stents > 3 years ago.
A total of 40 subjects will be enrolled in the study, with 20 patients who previously
received BMS > 3 years ago and 20 patients who previously received DES > 3 years ago
Non-Probability Sample
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
All18 YearsN/ANoRon Waksman, MDPrincipal InvestigatorMedstar Washington Hospital CenterMedstar Washington Hospital CenterWashingtonDistrict of Columbia20010United StatesUnited StatesAugust 2014April 12, 2013April 16, 2013April 18, 2013August 8, 2014August 8, 2014August 11, 2014SponsorCoronary Restenosis