Optical Coherence Tomography to Improve Clinical Outcomes During Coronary Angioplasty
|ClinicalTrials.gov Identifier: NCT02065102|
Recruitment Status : Completed
First Posted : February 17, 2014
Last Update Posted : March 6, 2014
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 or disease|
|Study Type :||Observational|
|Actual Enrollment :||12 participants|
|Official Title:||Optical Coherence Tomography to Improve Clinical Outcomes During Coronary Angioplasty|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||March 2014|
|Actual Study Completion Date :||March 2014|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02065102
|Royal Infirmary of Edinburgh|
|Edinburgh, Lothian, United Kingdom, EH16 4SA|
|Principal Investigator:||Nicholas L Cruden, MBChB PhD||Royal Infirmary of Edinburgh|