Clinical trial NCT04966273: Study to Evaluate the Safety and Effectiveness of the Biosensors Microcatheter in Coronary Chronic Total Occlusions (CTO) - 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
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Heart Disease
Keywords: Chronic Total Occlusion (CTO)
Microcatheter
CTO-PCI
Lead sponsor: Biosensors Europe SA
Sponsor class: INDUSTRY
First posted: 2021-07-19
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy: Percentage of patients with device success
timeFrame: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
measure: Safety: Percentage of patients with composite of in-hospital cardiac death or myocardial infarction.
timeFrame: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Secondary outcomes:
measure: Percentage of patients with technical success
timeFrame: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
measure: Percentage of patients with procedural success
timeFrame: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
measure: Percentage of patients with crossing success
timeFrame: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Other outcomes:
measure: Percentage of patients with device-related perforation
timeFrame: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
measure: Percentage of patients with device failure
timeFrame: Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Locations:
city: Basildon
country: United Kingdom
facility: Basildon and Thurrock University
state: Essex
city: Clydebank
country: United Kingdom
facility: Golden Jubilee Hospital,
state: Glasgow, Scotland
city: London
country: United Kingdom
facility: St George's Hospital, Blackshaw Road,
state: Tooting
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Bristol
country: United Kingdom
facility: Bristol Heart Institute, UHBW NHS Trust
city: Harrow
country: United Kingdom
facility: London North West University Healthcare Nhs Trust
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Leicester
country: United Kingdom
facility: Glenfield Hospital
city: Wales
country: United Kingdom
facility: University Hospital of Wales
Study officials:
affiliation: St. George's Hospital, London
name: James Sprattt, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Golden Jubilee National Hospital
name: Margaret MCENTEGART, Dr.
role: PRINCIPAL_INVESTIGATOR
References: