Suspended

Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Over 18 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: November 2011
See protocol details

Summary

Principal SponsorMedstar Health Research Institute
Last updated: August 11, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01835301
Principal SponsorMedstar Health Research Institute
Last updated: August 11, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Subject > 18 years of age
Subject is scheduled for a diagnostic coronary or interventional procedure
Subject is willing to sign the informed consent
Subject, male or female, who underwent DES or BMS implantation in a native coronary vessel more than 3 year ago
9 exclusion criteria prevent from participating
Angiographic evidence of >= 70% stenosis within the target stent (visual estimate)
Female subject is pregnant or lactating
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
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Medstar Washington Hospital Center

Washington D.C., United StatesOpen Medstar Washington Hospital Center in Google Maps
SuspendedOne Study Center