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
  Purpose

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
In-stent Coronary Artery Restenosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation

Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: November 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
DES
Patients who received a DES stent > 3 years ago.
BMS
Patients who received BMS stents > 3 years ago.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01835301

Locations
United States, District of Columbia
Medstar Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Ron Waksman, MD    202-877-5975    ron.waksman@medstar.net   
Principal Investigator: Ron Waksman, MD         
Sponsors and Collaborators
Medstar Research Institute
Investigators
Principal Investigator: Ron Waksman, MD Medstar Washington Hospital Center
  More Information

No publications provided

Responsible Party: Medstar Research Institute
ClinicalTrials.gov Identifier: NCT01835301     History of Changes
Other Study ID Numbers: IntraStent
Study First Received: April 12, 2013
Last Updated: October 31, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014