Optical Coherence Tomography to Improve Clinical Outcomes During Coronary Angioplasty

March 5, 2014 updated by: Nicholas Cruden, Royal Infirmary of Edinburgh

Coronary artery stenting has evolved as an effective treatment for angina and involves stretching up narrowings within the heart arteries using a balloon (coronary angioplasty) before implanting a small metal scaffold (stent) to splint the artery open. It is imperative that stents are fully expanded when they are deployed. If not, then patients are exposed to the serious risk of a blood clot forming in the stent (stent thrombosis), or the stent renarrowing (restenosis). One fifth of patients experiencing stent thrombosis will die and 70% will suffer a heart attack. Restenosis is associated with recurrent angina and heart attacks.

Arguably, visualising stents and ensuring adequate stent expansion is most challenging in patients with extensive hardening, or calcification, of the heart arteries. Optical coherence tomography is a novel technique that utilises near-infrared light to look inside small blood vessels in fine detail. It is 10 times more powerful than the best existing technique, intravascular ultrasound.

The purpose of this study is to compare the utility of optical coherence tomography with intravascular ultrasound in patients with heavily calcified heart arteries undergoing rotational atherectomy and coronary stent insertion. It is hoped that the results of this pilot study will provide proof-of-principle and justification for a larger clinical trial to formally assess the role of optical coherence tomography to guide coronary angioplasty and stenting in patients with heavily calcified coronary arteries.

Study Overview

Status

Completed

Conditions

Detailed Description

Twelve patients undergoing rotational atherectomy and coronary stenting for angina in Lothian will be recruited. Rotational atherectomy and stent implantation will be performed as part of routine clinical care. Immediately following stent implantation paired intravascular images of the implanted stent will be obtained using both intravascular ultrasound and optical coherence tomography. The stent will then be further dilated at high pressure with a non compliant balloon and the intravascular images repeated with both intravascular ultrasound and optical coherence tomography. The images obtained will be available to the operator to guide further treatment.

Study Type

Observational

Enrollment (Actual)

12

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 Kingdom
    • Lothian
      • Edinburgh, Lothian, United Kingdom, EH16 4SA
        • Royal Infirmary of Edinburgh

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing percutaneous coronary intervention requiring rotational atherectomy and coronary stent implantation in South East Scotland.

Description

Inclusion Criteria:

  • Patients undergoing percutaneous coronary intervention requiring rotational atherectomy and coronary stent implantation for calcified coronary artery disease.
  • Ability to give informed consent.

Exclusion Criteria:

  • Inability to provide informed consent.
  • Acute myocardial infarction.
  • Cardiogenic shock.
  • Renal failure (eGFR <30 mL/min) in patients who are not on dialysis.
  • Pregnancy.
  • Contrast allergy.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stent malposition expressed as % of total stent area
Time Frame: Day 1
The amount of stent not in direct contact with the blood vessel wall (malposition) expressed as a % of total stent area.
Day 1

Collaborators and Investigators

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

Sponsor

Royal Infirmary of Edinburgh

Investigators

  • Principal Investigator: Nicholas L Cruden, MBChB PhD, Royal Infirmary of Edinburgh

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

November 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

February 12, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimate)

February 17, 2014

Study Record Updates

Last Update Posted (Estimate)

March 6, 2014

Last Update Submitted That Met QC Criteria

March 5, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 12/R/CAR/13

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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