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

January 16, 2023 updated by: Biosensors Europe SA

A Prospective, Multi-Center, Non-randomized, Single Arm, Open Label, Study to Evaluate the Safety and Effectiveness of the Biosensors Microcatheter in Coronary Chronic Total Occlusions (CTO) - BIOMICS

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Prospective, multi-center, open-label single-arm trial designed to enroll 100 patients undergoing attempted CTO-PCI at up to 10 centers in the United Kingdom and N. Ireland. For assessment of efficacy, the ability of the BM to successfully facilitate placement of a guidewire beyond the occluded coronary segment will be assessed. Patients will be followed up until hospital discharge or 7 days post index procedure, whichever comes first. For the assessment of safety, the incidence of in-hospital cardiac death or myocardial infarction will be assessed at hospital discharge or 7 days post index procedure, whichever comes first.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United Kingdom
      • Belfast, United Kingdom, BT126BA
        • Royal Victoria Hospital
      • Bristol, United Kingdom, BS2 8HW
        • Bristol Heart Institute, UHBW NHS Trust
      • Harrow, United Kingdom, HA1 3UJ
        • London North West University Healthcare NHS Trust
      • Leeds, United Kingdom, LS1 3EX
        • Leeds General Infirmary
      • Leicester, United Kingdom, LE5 4PW
        • Glenfield Hospital
      • Wales, United Kingdom
        • University Hospital of Wales
    • Essex
      • Basildon, Essex, United Kingdom, SS16 5NL
        • Basildon and Thurrock University
    • Glasgow, Scotland
      • Clydebank, Glasgow, Scotland, United Kingdom, G81 4DY
        • Golden Jubilee Hospital,
    • Tooting
      • London, Tooting, United Kingdom, SW17 OQT
        • St George's Hospital, Blackshaw Road,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Adult aged > 18 years
  2. Patient understands and has signed the consent form.
  3. Patient has an angiographically documented chronic total occlusion (i.e. estimated to be >3 months duration) showing distal TIMI 0 flow. Occlusion with absence of antegrade flow through the lesion and with a presumed or documented duration of 3 months.
  4. Suitable candidate for non-emergent PCI
  5. Left ventricle ejection fraction > 25%

Exclusion Criteria:

  1. Patient unable to give informed consent.
  2. Current participation in another study with any investigational drug or device.
  3. Known or suspected contrast allergy.
  4. in-stent CTO.
  5. Planned treatment of a second CTO during the index procedure
  6. Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel or Prasugrel or Ticagrelor).
  7. Recent major cerebrovascular event (history of stroke or TIA within 1 month)
  8. Renal insufficiency (serum creatinine of > 200μmol/L)
  9. Active gastrointestinal bleeding
  10. Active infection or fever that may be due to infection
  11. Life expectancy < 2 years due to other illnesses
  12. Significant anaemia (haemoglobin < 10.0g/L)
  13. Severe uncontrolled systemic hypertension (> 240 mmHg within 1 month of procedure)
  14. Severe electrolyte imbalance
  15. Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV.
  16. Unstable angina requiring emergent PCI or coronary artery bypass graft (CABG)
  17. Recent myocardial infarction (MI) (within the past one week)
  18. Unwillingness or inability to comply with any protocol requirements
  19. Subject is pregnant or nursing. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
  20. Extensive prior dissection from a coronary guidewire use
  21. Drug abuse or alcoholism.
  22. Patients under custodial care.
  23. Bleeding diathesis or coagulation disorder
  24. Kawasaki's disease or other vasculitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Biosensors Microcatheter (BM)
Use of Biosensors Microcatheter
Device: Microcatheter
Only to be used if Biosensor Microcatheter does not perform accordingly
Other Names:
  • Standard hospital Microcatheter

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy: Percentage of patients with device success
Time Frame: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Device success defined as successful placement of a guidewire in the vessel across the occluded coronary segment
Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Safety: Percentage of patients with composite of in-hospital cardiac death or myocardial infarction.
Time Frame: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Composite of in-hospital cardiac death or myocardial infarction.
Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of patients with technical success
Time Frame: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Technical success is defined as achievement of TIMI grade 2 antegrade flow with less than 50% residual stenosis of the target CTO lesion at procedure end
Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Percentage of patients with procedural success
Time Frame: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Procedural success defined as technical success plus the absence of in-hospital MACE (death, myocardial infarction or clinically-driven target vessel revascularization (cd TVR)
Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Percentage of patients with crossing success
Time Frame: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Crossing success defined as the BM crossing the lesion
Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of patients with device-related perforation
Time Frame: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Device-related perforation at the site of target coronary lesion and/or its proximal reference segment including donor artery or collateral
Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Percentage of patients with device failure
Time Frame: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.

Device failure is defined as:

  • any evidence of fracture of any part of the microcatheter,
  • evidence of wire puncture of any part of the device
  • and/or evidence of a fragment being retained in the body of the patient after a procedure.
Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biosensors Europe SA

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: James Sprattt, Professor, St. George's Hospital, London
  • Principal Investigator: Margaret MCENTEGART, Dr., Golden Jubilee National Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 18, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 3, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 30, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20-EU-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

The emphasis in all scientific publications and presentations will be placed on the endpoint at discharge.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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