Back to resultsStudy to Evaluate the Safety and Effectiveness of the Biosensors Microcatheter in Coronary Chronic Total Occlusions (CTO) - BIOMICS (BIOMICS)
Primary Purpose
Ischemic Heart Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Microcatheter
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Heart Disease focused on measuring Chronic Total Occlusion (CTO), Microcatheter, CTO-PCI
Eligibility Criteria
Inclusion Criteria:
- 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%
Exclusion Criteria:
- 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.
- Unstable angina requiring emergent PCI or coronary artery bypass graft (CABG)
- Recent myocardial infarction (MI) (within the past one week)
- Unwillingness or inability to comply with any protocol requirements
- 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.
- Extensive prior dissection from a coronary guidewire use
- Drug abuse or alcoholism.
- Patients under custodial care.
- Bleeding diathesis or coagulation disorder
- Kawasaki's disease or other vasculitis
Sites / Locations
- Basildon and Thurrock University
- Golden Jubilee Hospital,
- St George's Hospital, Blackshaw Road,
- Royal Victoria Hospital
- Bristol Heart Institute, UHBW NHS Trust
- London North West University Healthcare Nhs Trust
- Leeds General Infirmary
- Glenfield Hospital
- University Hospital of Wales
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biosensors Microcatheter (BM)
Arm Description
Use of Biosensors Microcatheter
Outcomes
Primary Outcome Measures
Efficacy: Percentage of patients with device success
Device success defined as successful placement of a guidewire in the vessel across the occluded coronary segment
Safety: Percentage of patients with composite of in-hospital cardiac death or myocardial infarction.
Composite of in-hospital cardiac death or myocardial infarction.
Secondary Outcome Measures
Percentage of patients with technical success
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
Percentage of patients with procedural success
Procedural success defined as technical success plus the absence of in-hospital MACE (death, myocardial infarction or clinically-driven target vessel revascularization (cd TVR)
Percentage of patients with crossing success
Crossing success defined as the BM crossing the lesion
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04966273
Brief Title
Study to Evaluate the Safety and Effectiveness of the Biosensors Microcatheter in Coronary Chronic Total Occlusions (CTO) - BIOMICS
Acronym
BIOMICS
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 18, 2022 (Actual)
Primary Completion Date
January 3, 2023 (Actual)
Study Completion Date
January 3, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosensors Europe SA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
Keywords
Chronic Total Occlusion (CTO), Microcatheter, CTO-PCI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biosensors Microcatheter (BM)
Arm Type
Experimental
Arm Description
Use of Biosensors Microcatheter
Intervention Type
Device
Intervention Name(s)
Microcatheter
Other Intervention Name(s)
Standard hospital Microcatheter
Intervention Description
Only to be used if Biosensor Microcatheter does not perform accordingly
Primary Outcome Measure Information:
Title
Efficacy: Percentage of patients with device success
Description
Device success defined as successful placement of a guidewire in the vessel across the occluded coronary segment
Time Frame
Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Title
Safety: Percentage of patients with composite of in-hospital cardiac death or myocardial infarction.
Description
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.
Secondary Outcome Measure Information:
Title
Percentage of patients with technical success
Description
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
Time Frame
Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Title
Percentage of patients with procedural success
Description
Procedural success defined as technical success plus the absence of in-hospital MACE (death, myocardial infarction or clinically-driven target vessel revascularization (cd TVR)
Time Frame
Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Title
Percentage of patients with crossing success
Description
Crossing success defined as the BM crossing the lesion
Time Frame
Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Other Pre-specified Outcome Measures:
Title
Percentage of patients with device-related perforation
Description
Device-related perforation at the site of target coronary lesion and/or its proximal reference segment including donor artery or collateral
Time Frame
Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Title
Percentage of patients with device failure
Description
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.
Time Frame
Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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%
Exclusion Criteria:
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.
Unstable angina requiring emergent PCI or coronary artery bypass graft (CABG)
Recent myocardial infarction (MI) (within the past one week)
Unwillingness or inability to comply with any protocol requirements
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.
Extensive prior dissection from a coronary guidewire use
Drug abuse or alcoholism.
Patients under custodial care.
Bleeding diathesis or coagulation disorder
Kawasaki's disease or other vasculitis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Sprattt, Professor
Organizational Affiliation
St. George's Hospital, London
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Margaret MCENTEGART, Dr.
Organizational Affiliation
Golden Jubilee National Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Basildon and Thurrock University
City
Basildon
State/Province
Essex
ZIP/Postal Code
SS16 5NL
Country
United Kingdom
Facility Name
Golden Jubilee Hospital,
City
Clydebank
State/Province
Glasgow, Scotland
ZIP/Postal Code
G81 4DY
Country
United Kingdom
Facility Name
St George's Hospital, Blackshaw Road,
City
London
State/Province
Tooting
ZIP/Postal Code
SW17 OQT
Country
United Kingdom
Facility Name
Royal Victoria Hospital
City
Belfast
ZIP/Postal Code
BT126BA
Country
United Kingdom
Facility Name
Bristol Heart Institute, UHBW NHS Trust
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
London North West University Healthcare Nhs Trust
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Leeds General Infirmary
City
Leeds
ZIP/Postal Code
LS1 3EX
Country
United Kingdom
Facility Name
Glenfield Hospital
City
Leicester
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Wales
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The emphasis in all scientific publications and presentations will be placed on the endpoint at discharge.
Learn more about this trial
Study to Evaluate the Safety and Effectiveness of the Biosensors Microcatheter in Coronary Chronic Total Occlusions (CTO) - BIOMICS
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