This trial is active, not recruiting.

Condition in-stent coronary artery restenosis
Sponsor Medstar Research Institute
Start date November 2011
End date December 2015
Trial size 40 participants
Trial identifier NCT01835301, IntraStent


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Patients who received a DES stent > 3 years ago.
Patients who received BMS stents > 3 years ago.

Primary Outcomes

Plaque composition
time frame: During hospital stay, about 2 days.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation
Principal investigator Ron Waksman, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2014.
Information provided to ClinicalTrials.gov by Medstar Research Institute.