Balloon Inflation and Plaque Morphology in Revascularisation (BURST)

NCT ID: NCT03538067

Last Updated: 2018-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-30
• Study Completion Date: 2020-12-31

Brief 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).

Detailed 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.

Conditions

Coronary Artery Disease; Atherosclerosis

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Paired sample group

Patients with symptomatic coronary artery disease (stable, NSTEACS) undergoing planned percutaneous coronary intervention with intravascular ultrasound (IVUS) guidance

Percutaneous coronary intervention (PCI)

Intervention Type: PROCEDURE

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)

Interventions

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)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Redwood, MD FRCP FACC

Role: PRINCIPAL_INVESTIGATOR

King's College London, Guy's and St Thomas' Hospital, London

Central Contacts

Christopher J Allen, MBChB, MRCP

Role: CONTACT

christopher.allen@kcl.ac.uk

+44 (0)2071887184

Other Identifiers

212423

Identifier Type: -

Identifier Source: org_study_id