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

NCT03300167 | Withdrawn DMC

• 1 other identifier: STH19267
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Plasma prothrombin fragments

  Plasma prothrombin fragments 1+2 compared within-patients between samples from distal, mid and proximal ports

  during the percutaneous coronary intervention procedure

Secondary Outcomes (5)

• Fibrinopeptide A

  during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]

• Soluble platelet P-selectin

  during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]

• TXB2

  during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]

• platelet surface P-selectin expression

  during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]

• Leukocyte surface CD11b expression

  during the percutaneous coronary intervention procedure and 6 hours later [peri-procedural MI only]

Study Arms (1)

CE-marked coronary artery catheter

EXPERIMENTAL

use of a novel CE-marked coronary artery catheter to obtain spatially-separated intravascular samples for laboratory measurement.

Device: The Liquid Biopsy System

Interventions

The Liquid Biopsy System DEVICE

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.

CE-marked coronary artery catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged over 18 years
• Admitted to hospital with non-ST-elevation ACS and plan for either coronary angiography with a view to PCI if appropriate or PCI following coronary angiography at a referring hospital
• Current treatment with aspirin and ticagrelor or, if ticagrelor is not tolerated, prasugrel (DAPT)
• Ability to give informed consent

You may not qualify if:

• Treatment with antiplatelet medication apart from aspirin, ticagrelor, prasugrel or clopidogrel in the last 10 days (e.g. dipyridamole, abciximab, tirofiban).
• Planned use of a glycoprotein IIb/IIIa antagonist for the PCI procedure.
• Patients with haemodynamic instability, shock or angiographic evidence of intracoronary thrombus.
• Current use of an oral anticoagulant (e.g. warfarin, dabigatran, rivaroxaban, apixaban).
• Clinically significant liver disease.
• Contraindication or allergy to unfractionated heparin.
• Receiving immunosuppressant medication (eg. cyclosporin, tacrolimus, mycophenolate, azathioprine).
• Administration of doses of low molecular weight heparin or fondaparinux in the 12 hours preceding PCI.
• Known severe left ventricular dysfunction (ejection fraction \<30%).
• Culprit lesion in left main coronary artery.
• Women of childbearing potential unless pregnancy has been excluded during the index hospital admission.
• Known serum creatinine above upper limit of local reference range.
• Subjects with known active chronic inflammatory disease, e.g. systemic lupus erythematosus, rheumatoid arthritis, seropositive arthropathies and known seropositivity to HIV, Hepatitis B or Hepatitis C.
• Severely diseased, excessively tortuous or calcified coronary vessels that increase the risk of snaring the LBS.
• Culprit lesion in a coronary vessel with a reference diameter of less than 2.5 mm.

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: October 3, 2017
• Study Start: November 30, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: March 17, 2021

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)