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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01835301
Other study ID # IntraStent
Secondary ID
Status Active, not recruiting
Phase N/A
First received April 12, 2013
Last updated August 8, 2014
Start date November 2011

Study information

Verified date August 2014
Source Medstar Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Medstar Washington Hospital Center Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
Medstar Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plaque composition 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. During hospital stay, about 2 days. No
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