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

In-stent Coronary Artery Restenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01835301
• Other study ID #: IntraStent
• Status: Active, not recruiting
• Phase: N/A
• First received: April 12, 2013
• Last updated: August 8, 2014
• Start date: November 2011

Study information

• Verified date: August 2014
• Source: Medstar Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Restenosis
• In-stent Coronary Artery Restenosis

Locations

Country	Name	City	State
United States	Medstar Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No