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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01835301

Enrollment

Registered

2013-04-18

Start date

2011-11-30

Completion date

Unknown

Last updated

2014-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In-stent Coronary Artery Restenosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Plaque composition	During hospital stay, about 2 days.	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.

Countries

United States

Outcome results