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

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ClinicalTrials.gov Identifier: NCT01835301
Recruitment Status : Unknown
Verified August 2014 by Medstar Health Research Institute.
Recruitment status was:  Active, not recruiting
First Posted : April 18, 2013
Last Update Posted : August 11, 2014
Sponsor:
Information provided by (Responsible Party):
Medstar Health Research Institute

Brief 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.

Condition or disease
In-stent Coronary Artery Restenosis

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation
Study Start Date : November 2011
Estimated Primary Completion Date : December 2015

Group/Cohort
DES
Patients who received a DES stent > 3 years ago.
BMS
Patients who received BMS stents > 3 years ago.



Primary Outcome Measures :
  1. Plaque composition [ Time Frame: During hospital stay, about 2 days. ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01835301


Locations
United States, District of Columbia
Medstar Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Health Research Institute
Investigators
Principal Investigator: Ron Waksman, MD Medstar Washington Hospital Center

Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT01835301     History of Changes
Other Study ID Numbers: IntraStent
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: August 11, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Coronary Restenosis
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases