Intra-stent Tissue Evaluation Within BMS and DES

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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In-stent Coronary Artery Restenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DES

Patients who received a DES stent \> 3 years ago.

No interventions assigned to this group

BMS

Patients who received BMS stents \> 3 years ago.

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No