Balloon Inflation and Plaque Morphology in Revascularisation (BURST)

Coronary Artery Disease Clinical Trial

— BURST  

Official title:

Influence of Balloon Inflation Techniques and Plaque Characteristics on Stent Under-expansion in Percutaneous RevasculariSaTion (BURST)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03538067
• Other study ID #: 212423
• Status: Not yet recruiting
• Start date: June 2018
• Est. completion date: December 2020

Study information

• Verified date: May 2018
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Christopher J Allen, MBChB, MRCP
• Phone: +44 (0)2071887184
• Email: christopher.allen[@]kcl.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study will look at the effects of standardised balloon inflation times, pressure and balloon types and atherosclerotic plaque morphology on the procedural results of percutaneous coronary intervention (PCI).

Description:

Patients presenting with symptoms of coronary artery disease (e.g. chest pain - angina) are often treated with stents (referred to as percutaneous coronary intervention, PCI). Stents treat the cause of symptoms by improving blood flow to the heart muscle through expanding a narrowed, or diseased segment within a coronary artery. The procedure involves the inflation of a balloon to expand the stent inside the artery. As part of standard clinical care multiple balloon inflations are required during the procedure. Deficiencies in the expansion of the stent at the time of the procedure are associated serious complications such as stent blockages or re-narrowing of the artery, either of which may not occur until much later.

Improvements to the technique of stent expansion are therefore highly desirable to improve outcomes for patients. A number of factors are thought to influence the success of the procedure, including: the type of balloon used to inflate the stent, the pressure used and the duration of balloon inflation. Another important factor may be the mechanical properties of the narrowed segment of the artery (plaque) and how they interact with the stent. At present however, there is no consensus view and the practise of individual cardiologists consequently remains highly variable.

The aim of this study is better characterise relationship between pressure and duration of balloon inflation, type of balloon used and plaque properties during stent procedures using state-of-the-art imaging. Although assessment of each of these factors by a cardiologist is already included as part of standard care, our research protocol will focus the analysis into a systematic framework to allow conclusions to be drawn. The findings will used better inform cardiologists of the technical modifications that can help improve stenting procedures and translate to better outcomes for patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with symptomatic coronary artery disease (stable angina, non-ST elevation acute coronary syndromes) undergoing percutaneous coronary intervention with intracoronary ultrasound (IVUS) guidance

• Patients > 18 years

• De novo coronary stenoses in native coronary arteries

• Written informed consent

Exclusion Criteria:

• ST-elevation acute coronary syndrome

• Haemodynamic instability

• Cardiogenic shock

• Severe renal dysfunction (eGFR < 30 ml/min/1.73m2)

• In-stent restenosis

• Chronic total occlusions

• Saphenous vein and arterial bypass grafts

• Patients who are currently enrolled in any other study where involvement in this study would involve significant deviation from either protocol

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Percutaneous coronary intervention (PCI)
Patients will undergo PCI with intravascular ultrasound (IVUS) as part of standard clinical care in accordance with operator discretion. The research protocol will be observational - using IVUS to determine the effects of balloon inflation time, balloon inflation pressure, balloon type, atherosclerotic plaque morphology on stent expansion (minimal luminal area, MLA)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust	King's College London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-stent minimal luminal area (MLA, mm2)	As measured by intravascular ultrasound	Immediate - peri-procedurally
Secondary	Plaque characteristics	As determined by virtual histology intravascular ultrasound (VH-IVUS)	Immediate - peri-procedural
Secondary	Stent deployment	Determined by intravascular ultrasound (IVUS - MUSIC Criteria)	Immediate - peri-procedural
Secondary	Peri-procedural myocardial infarction	In accordance with academic research consortium (ARC) definition	Immediate - peri-procedural