NCT02065102

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 17, 2014

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 6, 2014

Status Verified

March 1, 2014

Enrollment Period

1.3 years

First QC Date

February 12, 2014

Last Update Submit

March 5, 2014

Conditions

Angina

Keywords

Rotational atherectomyAnginaOptical coherence tomographyIntravascular ultrasoundCoronary stent

Outcome Measures

Primary Outcomes (1)

  • Stent malposition expressed as % of total stent area

    The amount of stent not in direct contact with the blood vessel wall (malposition) expressed as a % of total stent area.

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Infirmary of Edinburgh

Edinburgh, Lothian, EH16 4SA, United Kingdom

Location

Related Publications (1)

  • Gudmundsdottir I, Adamson P, Gray C, Spratt JC, Behan MW, Henriksen P, Newby DE, Mills N, Uren NG, Cruden NL. Optical coherence tomography versus intravascular ultrasound to evaluate stent implantation in patients with calcific coronary artery disease. Open Heart. 2015 Dec 22;2(1):e000225. doi: 10.1136/openhrt-2014-000225. eCollection 2015.

    PMID: 26719807DERIVED

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nicholas L Cruden, MBChB PhD

    Royal Infirmary of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Cardiologist

Study Record Dates

First Submitted

February 12, 2014

First Posted

February 17, 2014

Study Start

November 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 6, 2014

Record last verified: 2014-03

Locations

GB(1)