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Study of the Vascular Response to Percutaneous Coronary Intervention in Patients With Non-ST-elevation Acute Coronary Syndromes Using Intravascular Blood Sampling

NCT03300167 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-03-17

No results posted yet for this study

Summary

This interventional study is using the PlaqueTec LBS will enrol participants already undergoing coronary angiography as a component of their standard care for NSTE-ACS. The study will involve no change to medication or overall treatment strategy, but will involve an additional procedure: use of a novel CE-marked coronary artery catheter to obtain spatially-separated intravascular samples for laboratory measurement. As a safety objective and as a component of the required post-marketing surveillance, OCT will be performed before and after deployment of the LBS, and patients will be followed up for a significant period of time by the investigator's post-procedure.

Individual participants will not gain directly from taking part in the study, other than having access to more prolonged follow up than is standard. However, new insights will be gained into the microenvironment surrounding a ruptured plaque in NSTE-ACS, which has the potential to benefit patients with CAD in the future through greater understanding of the effects of current therapy, development of new treatment strategies and methods of assessing the efficacy of those treatment strategies.

Use of the LBS and the associated OCT examinations will require additional angiographic screening and therefore lead to greater exposure to radiation and higher contrast load. This will be closely monitored as per Trust policies in line with IRMER and local radiological guidelines. Patients at particular risk of developing complications from increased exposure to radiation and contrast (eg. those who are pregnant and those with abnormal baseline renal function) will not be included in order to minimise adverse effects.

Conditions

  • Non ST Segment Elevation Acute Coronary Syndrome

Interventions

DEVICE

The Liquid Biopsy System

The Liquid Biopsy System is a single use percutaneously-delivered coronary blood sampling device designed to collect blood samples from within a target coronary artery so that the blood can be analysed.

Sponsors & Collaborators

  • Sheffield Teaching Hospitals NHS Foundation Trust

    lead OTHER

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-30
Primary Completion
2020-06-30
Completion
2020-06-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03300167 on ClinicalTrials.gov