Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Medstar Research Institute
First received: April 12, 2013
Last updated: August 8, 2014
Last verified: August 2014
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.
In-stent Coronary Artery Restenosis
||Observational Model: Cohort
Time Perspective: Prospective
||Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation
Primary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||December 2015 (Final data collection date for primary outcome measure)
Patients who received a DES stent > 3 years ago.
Patients who received BMS stents > 3 years ago.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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
- 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.
- 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01835301
|Medstar Washington Hospital Center
|Washington, District of Columbia, United States, 20010 |
Medstar Research Institute
||Ron Waksman, MD
||Medstar Washington Hospital Center
No publications provided
||Medstar Research Institute
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 12, 2013
||August 8, 2014
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 02, 2014