Intra-stent Tissue Evaluation Within BMS and DES > 3 Year... | NCT01835301

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

NCT01835301

Sponsor

Medstar Health Research Institute

Status

Unknown status

Last Update Posted

Aug 11, 2014Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

In-stent Coronary Artery Restenosis

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2011

Primary Completion Date

Dec 2015Estimated

Completion Date

Not provided

First Submitted Date

Apr 12, 2013

First Submission Date that Met QC Criteria

Apr 16, 2013

First Posted Date

Apr 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 8, 2014

Last Update Posted Date

Aug 11, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Label	Type	Description	Intervention Names
DES		Patients who received a DES stent > 3 years ago.
BMS		Patients who received BMS stents > 3 years ago.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ron Waksman, MD	Medstar Health Research Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medstar Washington Hospital Center		Washington D.C.	District of Columbia	20010	United States