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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT01835301
First received: April 12, 2013
Last updated: August 8, 2014
Last verified: August 2014
  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 2015 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01835301

Locations
United States, District of Columbia
Medstar Washington Hospital Center
Washington, District of Columbia, United States, 20010
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: August 8, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014