Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation
Verified October 2013 by Medstar Research Institute
Information provided by (Responsible Party):
Medstar Research Institute
First received: April 12, 2013
Last updated: October 31, 2013
Last verified: October 2013
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 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01835301
|Medstar Washington Hospital Center
|Washington, District of Columbia, United States, 20010 |
|Contact: Ron Waksman, MD 202-877-5975 firstname.lastname@example.org |
|Principal Investigator: Ron Waksman, MD |
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
||October 31, 2013
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 22, 2014