Balloon Inflation and Plaque Morphology in Revascularisation (BURST)

Overview

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).

Full Title of Study: “Influence of Balloon Inflation Techniques and Plaque Characteristics on Stent Under-expansion in Percutaneous RevasculariSaTion (BURST)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2020

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.

Interventions

  • 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)

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • In-stent minimal luminal area (MLA, mm2)
    • Time Frame: Immediate – peri-procedurally
    • As measured by intravascular ultrasound

Secondary Measures

  • Plaque characteristics
    • Time Frame: Immediate – peri-procedural
    • As determined by virtual histology intravascular ultrasound (VH-IVUS)
  • Stent deployment
    • Time Frame: Immediate – peri-procedural
    • Determined by intravascular ultrasound (IVUS – MUSIC Criteria)
  • Peri-procedural myocardial infarction
    • Time Frame: Immediate – peri-procedural
    • In accordance with academic research consortium (ARC) definition

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Guy’s and St Thomas’ NHS Foundation Trust
  • Collaborator
    • King’s College London
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Simon Redwood, MD FRCP FACC, Principal Investigator, King’s College London, Guy’s and St Thomas’ Hospital, London
  • Overall Contact(s)
    • Christopher J Allen, MBChB, MRCP, +44 (0)2071887184, christopher.allen@kcl.ac.uk

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