NCT03538067

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2017

Completed
10 months until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 25, 2018

Status Verified

May 1, 2018

Enrollment Period

2 years

First QC Date

July 31, 2017

Last Update Submit

May 15, 2018

Conditions

Coronary Artery DiseaseAtherosclerosis

Keywords

percutaneous coronary interventionstent appositionstent deploymentstent expansionintravascular ultrasound

Outcome Measures

Primary Outcomes (1)

  • In-stent minimal luminal area (MLA, mm2)

    As measured by intravascular ultrasound

    Immediate - peri-procedurally

Secondary Outcomes (3)

  • Plaque characteristics

    Immediate - peri-procedural

  • Stent deployment

    Immediate - peri-procedural

  • Peri-procedural myocardial infarction

    Immediate - peri-procedural

Study Arms (1)

Paired sample group

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

Procedure: Percutaneous coronary intervention (PCI)

Interventions

Percutaneous coronary intervention (PCI)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)

Paired sample group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with symptomatic coronary artery disease (stable angina, non-ST elevation acute coronary syndromes) already referred for coronary intervention will be prospectively enrolled sequentially as they attend the St Thomas' Cardiac Catheterisation Laboratories.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood samples

MeSH Terms

Conditions

Coronary Artery DiseaseAtherosclerosis

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Simon Redwood, MD FRCP FACC

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher J Allen, MBChB, MRCP

CONTACT

+44 (0)2071887184christopher.allen@kcl.ac.uk

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2017

First Posted

May 25, 2018

Study Start

June 1, 2018

Primary Completion

June 1, 2020

Study Completion

December 1, 2020

Last Updated

May 25, 2018

Record last verified: 2018-05