Optical Frequency Domain Imaging (OFDI) and Vascular Healing After Stent Placement (OFDI-DM)

April 6, 2017 updated by: Henry A Liberman, Emory University

Optical Frequency Domain Imaging (OFDI) Determined Stent Strut Coverage and Plaque Morphology After RESOLUTE Stent Placement in Non-Insulin Dependent Diabetics Presenting With Acute Coronary Syndrome (ACS)

The use of drug eluting stents (DES) used to treat coronary artery blockages is limited by poor healing of the stented area. This will require the combined use of blood thinners such as aspirin and clopidogrel (i.e. dual anti-platelet therapy (DAPT)) to prevent complications such as clot formation on the stent which may lead to a heart attack. Diabetic patients and those presenting with a heart attack at the time of stent placement are at increased risk for clot formation. However, little is known of the healing responses after stent placement in these populations.

Currently all patients receiving DES are advised to complete DAPT for twelve months although more personalized durations of DAPT based on stent healing would reduce both clot formation and potential bleeding from the blood thinners, thereby improving the long-term safety of DES.

Intracoronary optical frequency domain imaging (OFDI) is a novel high resolution invasive imaging technique that has the ability to evaluate stent healing at follow-up. Among the commercially available coated stents used in the U.S., the zotarolimus eluting stents (RESOLUTE Integrity, Medtronic, Minneapolis, MN) has demonstrated superior healing in both preclinical and clinical studies.

The purpose of this trial is to determine the healing responses of the RESOLUTE Integrity stent as detected by OFDI in patients with and without diabetes presenting with ACS. Specifically, in this observational study, the study team will investigate non-insulin dependent diabetics and non-diabetics in the setting of ACS and RESOLUTE Integrity stent placement.

The investigators hypothesize that healing responses in patients with non-insulin dependent diabetes will be similar to those without diabetes presenting with ACS and that a majority of patients will demonstrate complete healing as determined by OFDI measurements.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The long-term efficacy of drug eluting stents (DES) used to treat symptomatic coronary artery disease is limited by incomplete healing of the stented segment necessitating the use of dual anti-platelet therapy (DAPT) with aspirin and a thienopyridine to prevent these late thrombotic complications. Diabetic patients and those presenting with acute coronary syndrome (ACS) at the time of DES placement are at increased risk for late in stent thrombosis, however, little is known of the healing responses in these populations.

Currently all patients receiving DES are advised to complete DAPT for twelve months although more personalized durations of DAPT based on stent healing would reduce both thrombosis and bleeding, thereby improving the long-term safety of DES. Intracoronary optical frequency domain imaging (OFDI) is a novel high resolution invasive imaging modality with the potential to discern plaque morphology at stent placement and stent strut healing at follow-up. Among the commercially available coated stents used in the U.S., the zotarolimus eluting stents (RESOLUTE, Medtronic, Minneapolis, MN) has demonstrated superior endothelialization and long term safety data in both preclinical and clinical studies.

The purpose of this trial is to determine the healing responses to the RESOLUTE stent as detected by OFDI in patients with and without diabetes presenting with ACS. Specifically, investigators will 1) determine while using OFDI whether any difference in healing occurs in non-insulin dependent diabetic patients presenting with ACS after RESOLUTE stent placement at 6 months; 2) determine how initial plaque morphology and angiographic measures such as late loss correlate with stent strut healing; and 3) examine whether selected biomarkers have an utility in predicting stent strut healing by OFDI.

Investigators will conduct a clinical study that images subjects at baseline and at 6 months after stent placement with intracoronary OFDI. OFDI data will be utilized to determine plaque morphology prior to intervention, ensure adequate strut apposition and stent sizing immediately post deployment and to measure stent strut coverage at 6 month follow-up. Two follow-up imaging passes will be conducted to evaluate test-retest variability of the coverage measurement. In addition to assessing the feasibility of using the OFDI coverage metric in vivo, this data may provide information on the magnitude of coverage that can be expected at 6 months following RESOLUTE stents.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any patient requiring percutaneous transluminal coronary interventions (PTCI) for acute coronary syndrome (ACS) and meeting criteria (as determined by the performing physician) for Resolute Integrity stent placement.

Exclusion Criteria:

  • ST segment elevation MI (STEMI)
  • stable angina
  • current or planned pregnancy (for women of childbearing age)
  • treatment of > 2 lesions during the index hospitalization
  • insulin dependent diabetic patients at the time of stent placement
  • use of overlapping stents.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-diabetic patients receiving the Resolute stent
Non-diabetic patients presenting with Acute Coronary Syndrome (ACS), receiving the Resolute stent.
Device: Resolute Integrity stent
Drug eluting stents used to treat coronary artery blockages
Experimental: Diabetic patients receiving the Resolute stent
Non-insulin dependent diabetes mellitus (NIDDM) patients presenting with Acute Coronary Syndrome (ACS), receiving the Resolute stent.
Device: Resolute Integrity stent
Drug eluting stents used to treat coronary artery blockages

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Stent Coverage
Time Frame: 6 months
Assessment of vascular healing 6 months after Resolute Integrity placement in non-diabetic patients and patients with non-insulin dependent diabetes presenting with acute coronary syndrome (ACS) using optical frequency domain imaging (OFDI). Vascular healing will be measured by percent covered stents as determined by OFDI. A higher percentage of stent coverage indicates increased endothelial regrowth, which is an essential component for the maintenance of long-term luminal patency.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Henry Liberman, MD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

November 7, 2012

First Submitted That Met QC Criteria

February 17, 2013

First Posted (Estimate)

February 20, 2013

Study Record Updates

Last Update Posted (Actual)

May 15, 2017

Last Update Submitted That Met QC Criteria

April 6, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00057208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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