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

This study is currently recruiting participants.
Verified October 2013 by Medstar Research Institute
Sponsor:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01835301
First received: April 12, 2013
Last updated: October 31, 2013
Last verified: October 2013

April 12, 2013
October 31, 2013
November 2011
December 2013   (final data collection date for primary outcome measure)
Plaque composition [ Time Frame: During hospital stay, about 2 days. ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01835301 on ClinicalTrials.gov Archive Site
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Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation
Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation

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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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

In-stent Coronary Artery Restenosis
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  • DES
    Patients who received a DES stent > 3 years ago.
  • BMS
    Patients who received BMS stents > 3 years ago.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
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December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
United States
 
NCT01835301
IntraStent
No
Medstar Research Institute
Medstar Research Institute
Not Provided
Principal Investigator: Ron Waksman, MD Medstar Washington Hospital Center
Medstar Research Institute
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP