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

MedStar Health

Status: Unknown

Conditions: In-stent Coronary Artery Restenosis

Study type: Observational

Funder types: Other

Identifiers

NCT01835301

IntraStent

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 2 patient groups

DES

Description:

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

BMS

Description:

Patients who received BMS stents \> 3 years ago.