Ischemic Heart DiseaseBIOMICSNCT04966273
Study to Evaluate the Safety and Effectiveness of the Biosensors Microcatheter in Coronary Chronic Total Occlusions (CTO) - BIOMICS
A study testing Microcatheter in people with Ischemic Heart Disease, run by Biosensors Europe SA at 9 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Microcatheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 9 sitesUnited Kingdom
- Study dates
- 18 Mar 2022to 3 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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).
Show all 24Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United Kingdom9 sites
Basildon and Thurrock University
Basildon, Essex, SS16 5NL
Royal Victoria Hospital
Belfast, BT126BA
Bristol Heart Institute, UHBW NHS Trust
Bristol, BS2 8HW
Golden Jubilee Hospital,
Clydebank, Glasgow, Scotland, G81 4DY
London North West University Healthcare Nhs Trust
Harrow, HA1 3UJ
Leeds General Infirmary
Leeds, LS1 3EX
Glenfield Hospital
Leicester, LE5 4PW
St George's Hospital, Blackshaw Road,
London, Tooting, SW17 OQT
University Hospital of Wales
Wales
About this study
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
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.
Read the 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.
- Conditions
- Ischemic Heart Disease
- Being tested
- Microcatheter
- Keywords
- Chronic Total Occlusion (CTO), Microcatheter, CTO-PCI
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrocatheterDevice
Also called Standard hospital Microcatheter
Only to be used if Biosensor Microcatheter does not perform accordingly
| Study group | Role | What they receive |
|---|---|---|
| Biosensors Microcatheter (BM) | Experimental | Use of Biosensors Microcatheter Receives: Device: Microcatheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Percentage of patients with device success
Device success defined as successful placement of a guidewire in the vessel across the occluded coronary segment
Measured: 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.
Measured: 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
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
Measured: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
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)
Measured: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Percentage of patients with crossing success
Crossing success defined as the BM crossing the lesion
Measured: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start18 Mar 2022
- Primary completion3 Jan 2023
- Study completion3 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosensors Europe SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Sprattt, Professor, Principal investigator, St. George's Hospital, LondonMargaret MCENTEGART, Dr., Principal investigator, Golden Jubilee National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966273
- Sponsor's protocol ID
- 20-EU-01
- Acronym
- BIOMICS
- Status last verified
- Jan 2023
- First submitted
- 30 Jun 2021
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The emphasis in all scientific publications and presentations will be placed on the endpoint at discharge.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04966273
- Acronym / sponsor ID
- BIOMICS / 20-EU-01
- Conditions
- Ischemic Heart Disease
- Keywords
- Chronic Total Occlusion (CTO), Microcatheter, CTO-PCI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Biosensors Europe SAIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 3 Jan 2023 (actual)
- First posted
- 19 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Biosensors Microcatheter (BM) | Experimental | Device: MicrocatheterUse of Biosensors Microcatheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MicrocatheterAlso: Standard hospital MicrocatheterOnly to be used if Biosensor Microcatheter does not perform accordingly | Device | Biosensors Microcatheter (BM) |
Primary outcome
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
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.
3 secondary outcomes
Percentage of patients with technical success
Time frame: 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.
Percentage of patients with crossing success
Time frame: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Individual participant dataSharing planned: Yes. The emphasis in all scientific publications and presentations will be placed on the endpoint at discharge.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Sprattt, Professor principal investigator
St. George's Hospital, London
Margaret MCENTEGART, Dr. principal investigator
Golden Jubilee National Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microcatheter in people with Ischemic Heart Disease, run by Biosensors Europe SA at 9 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2023.