Clinical trial NCT02065102: Optical Coherence Tomography to Improve Clinical Outcomes During Coronary Angioplasty
Official title: Optical Coherence Tomography to Improve Clinical Outcomes During Coronary Angioplasty
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Angina
Keywords: Rotational atherectomy
Angina
Optical coherence tomography
Intravascular ultrasound
Coronary stent
Lead sponsor: Royal Infirmary of Edinburgh
Sponsor class: OTHER
First posted: 2014-02-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing percutaneous coronary intervention requiring rotational atherectomy and coronary stent implantation in South East Scotland.

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.

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 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.

Primary outcomes:
measure: Stent malposition expressed as % of total stent area
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
state: Lothian
Study officials:
affiliation: Royal Infirmary of Edinburgh
name: Nicholas L Cruden, MBChB PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.