Optical Coherence Tomography to Improve Clinical Outcomes During Coronary Angioplasty

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nicholas Cruden, Royal Infirmary of Edinburgh
ClinicalTrials.gov Identifier:
NCT02065102
First received: February 12, 2014
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition
Angina

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Optical Coherence Tomography to Improve Clinical Outcomes During Coronary Angioplasty

Resource links provided by NLM:


Further study details as provided by Royal Infirmary of Edinburgh:

Primary Outcome Measures:
  • Stent malposition expressed as % of total stent area [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    The amount of stent not in direct contact with the blood vessel wall (malposition) expressed as a % of total stent area.


Enrollment: 12
Study Start Date: November 2012
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02065102

Locations
United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Lothian, United Kingdom, EH16 4SA
Sponsors and Collaborators
Royal Infirmary of Edinburgh
Investigators
Principal Investigator: Nicholas L Cruden, MBChB PhD Royal Infirmary of Edinburgh
  More Information

No publications provided

Responsible Party: Nicholas Cruden, Consultant Cardiologist, Royal Infirmary of Edinburgh
ClinicalTrials.gov Identifier: NCT02065102     History of Changes
Other Study ID Numbers: 12/R/CAR/13
Study First Received: February 12, 2014
Last Updated: March 5, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by Royal Infirmary of Edinburgh:
Rotational atherectomy
Angina
Optical coherence tomography
Intravascular ultrasound
Coronary stent

ClinicalTrials.gov processed this record on October 19, 2014