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

Not Applicable

Completed

• Conditions: Ischemic Heart Disease
• Interventions: Device: Microcatheter

• Registration Number: NCT04966273
• Lead Sponsor: Biosensors Europe SA

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.

Study Timeline

• Study First Submitted: 2021-06-30
• Study First Submitted QC: 2021-07-07
• Study First Posted: 2021-07-19
• Study Start: 2022-03-18
• Status Verified: 2023-01
• Primary Completion: 2023-01-03
• Study Completion: 2023-01-03
• Last Update Submitted: 2023-01-16
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biosensors Microcatheter (BM)	Microcatheter	Use of Biosensors Microcatheter

Primary Outcome Measures

Name	Time	Method
Efficacy: Percentage of patients with device success	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.	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with technical success	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
Percentage of patients with procedural success	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)
Percentage of patients with crossing success	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

Trial Locations

Locations (9)

Leeds General Infirmary; 🇬🇧 Leeds, United Kingdom

Glenfield Hospital; 🇬🇧 Leicester, United Kingdom

Basildon and Thurrock University; 🇬🇧 Basildon, Essex, United Kingdom

Golden Jubilee Hospital,; 🇬🇧 Clydebank, Glasgow, Scotland, United Kingdom

St George's Hospital, Blackshaw Road,; 🇬🇧 London, Tooting, United Kingdom

Royal Victoria Hospital; 🇬🇧 Belfast, United Kingdom

Bristol Heart Institute, UHBW NHS Trust; 🇬🇧 Bristol, United Kingdom

London North West University Healthcare Nhs Trust; 🇬🇧 Harrow, United Kingdom

University Hospital of Wales; 🇬🇧 Wales, United Kingdom