Study to Evaluate the Safety and Effectiveness of the Biosensors Microcatheter in Coronary Chronic Total Occlusions (CTO) - BIOMICS
BIOMICS
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
1 other identifier
interventional
101
1 country
9
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2022
Shorter than P25 for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 30, 2021
CompletedFirst Posted
Study publicly available on registry
July 19, 2021
CompletedStudy Start
First participant enrolled
March 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 3, 2023
CompletedJanuary 18, 2023
January 1, 2023
10 months
June 30, 2021
January 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Efficacy: Percentage of patients with device success
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.
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 Outcomes (3)
Percentage of patients with technical success
Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Percentage of patients with procedural success
Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Percentage of patients with crossing success
Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Other Outcomes (2)
Percentage of patients with device-related perforation
Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Percentage of patients with device failure
Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Study Arms (1)
Biosensors Microcatheter (BM)
EXPERIMENTALUse of Biosensors Microcatheter
Interventions
Only to be used if Biosensor Microcatheter does not perform accordingly
Eligibility Criteria
You may qualify if:
- Adult aged \> 18 years
- Patient understands and has signed the consent form.
- 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.
- Suitable candidate for non-emergent PCI
- Left ventricle ejection fraction \> 25%
You may not qualify if:
- Patient unable to give informed consent.
- Current participation in another study with any investigational drug or device.
- Known or suspected contrast allergy.
- in-stent CTO.
- Planned treatment of a second CTO during the index procedure
- Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel or Prasugrel or Ticagrelor).
- Recent major cerebrovascular event (history of stroke or TIA within 1 month)
- Renal insufficiency (serum creatinine of \> 200μmol/L)
- Active gastrointestinal bleeding
- Active infection or fever that may be due to infection
- Life expectancy \< 2 years due to other illnesses
- Significant anaemia (haemoglobin \< 10.0g/L)
- Severe uncontrolled systemic hypertension (\> 240 mmHg within 1 month of procedure)
- Severe electrolyte imbalance
- Congestive heart failure \[New York Heart Association (NYHA) Class III\\IV\] CSA Class IV.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Basildon and Thurrock University
Basildon, Essex, SS16 5NL, United Kingdom
Golden Jubilee Hospital,
Clydebank, Glasgow, Scotland, G81 4DY, United Kingdom
St George's Hospital, Blackshaw Road,
London, Tooting, SW17 OQT, United Kingdom
Royal Victoria Hospital
Belfast, BT126BA, United Kingdom
Bristol Heart Institute, UHBW NHS Trust
Bristol, BS2 8HW, United Kingdom
London North West University Healthcare Nhs Trust
Harrow, HA1 3UJ, United Kingdom
Leeds General Infirmary
Leeds, LS1 3EX, United Kingdom
Glenfield Hospital
Leicester, LE5 4PW, United Kingdom
University Hospital of Wales
Wales, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James Sprattt, Professor
St. George's Hospital, London
- PRINCIPAL INVESTIGATOR
Margaret MCENTEGART, Dr.
Golden Jubilee National Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2021
First Posted
July 19, 2021
Study Start
March 18, 2022
Primary Completion
January 3, 2023
Study Completion
January 3, 2023
Last Updated
January 18, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will share
The emphasis in all scientific publications and presentations will be placed on the endpoint at discharge.