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

February 12, 2014
March 5, 2014
November 2012
March 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02065102 on ClinicalTrials.gov Archive Site
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Optical Coherence Tomography to Improve Clinical Outcomes During Coronary Angioplasty
Optical Coherence Tomography to Improve Clinical Outcomes During Coronary Angioplasty

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.

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.

Observational
Observational Model: Case-Crossover
Time Perspective: Prospective
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Non-Probability Sample

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

Angina
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2014
March 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT02065102
12/R/CAR/13
No
Nicholas Cruden, Royal Infirmary of Edinburgh
Royal Infirmary of Edinburgh
Not Provided
Principal Investigator: Nicholas L Cruden, MBChB PhD Royal Infirmary of Edinburgh
Royal Infirmary of Edinburgh
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP