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

NCT01835301 | Unknown

• 1 other identifier: IntraStent
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

In-stent Coronary Artery Restenosis

Outcome Measures

Primary Outcomes (1)

• Plaque composition

  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.

  During hospital stay, about 2 days.

Study Arms (2)

DES

Patients who received a DES stent \> 3 years ago.

BMS

Patients who received BMS stents \> 3 years ago.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

Medstar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Study Officials

• Ron Waksman, MD

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: April 18, 2013
• Study Start: November 1, 2011
• Primary Completion: December 1, 2015
• Last Updated: August 11, 2014

Record last verified: 2014-08

Locations

US (1)