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Study to Evaluate the Safety and Effectiveness of the Biosensors Microcatheter in Coronary Chronic Total Occlusions (CTO) - BIOMICS

NCT04966273 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2023-01-18

No results posted yet for this study

Summary

Biosensors, the Sponsor would like to determine if the Biosensors Microcatheter is safe and effective in treating patients with CTO by assessing a composite of in-hospital cardiac death or myocardial infarction and device success (defined as successfully facilitate placement of a guidewire beyond the occluded coronary segment), respectively.

Conditions

  • Ischemic Heart Disease

Interventions

DEVICE

Microcatheter

Only to be used if Biosensor Microcatheter does not perform accordingly

Sponsors & Collaborators

  • Biosensors Europe SA

    lead INDUSTRY

Principal Investigators

  • James Sprattt, Professor · St. George's Hospital, London

  • Margaret MCENTEGART, Dr. · Golden Jubilee National Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-18
Primary Completion
2023-01-03
Completion
2023-01-03

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 NCT04966273 on ClinicalTrials.gov