Optical Coherence Tomography to Improve Clinical Outcomes During Coronary Angioplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Does Co-registration of OCT and Angiography Reduce Geographic Miss of Stent Implantation?

NCT02671123

Coronary Artery Disease

UNKNOWN NA

Morphological Parameters of In-stent RESTenosis Assessed and Identified by OCT

NCT04268875

In-stent Restenosis

COMPLETED NA

Does OCT Imaging Allow us to See Blood Vessel Development in and Around Deposits of Fat and Calcium Inside Blood Vessels

NCT03182348

Cardiovascular Disease

COMPLETED

Clinical Significance of Pre-interventional Optical Coherence Tomography in Bioresorbable Vascular Scaffold Implantation

NCT02894697

Myocardial Ischemia

TERMINATED NA

Observational Study of Angiographic Coregistered Optical Coherence Tomography in Patients Undergoing PCI

NCT02919943

Coronary Artery Disease

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Angina

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No