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

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Heart Disease
• Intervention / Treatment: Device: Microcatheter

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 Type: Interventional
• Enrollment (Actual): 101
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Keith Oldroyd, Prof.; Phone Number: +41 21 804 8000; Email: k.oldroyd@biosensors.com
• Study Contact Backup: Name: Diana Schuette, Dr.; Phone Number: +41 21 804 8000; Email: d.schuette@biosensors.com

Study Locations

• United Kingdom
  • Belfast, United Kingdom, BT126BA
    • Royal Victoria Hospital
  • Bristol, United Kingdom, BS2 8HW
    • Bristol Heart Institute, UHBW NHS Trust
  • Harrow, United Kingdom, HA1 3UJ
    • London North West University Healthcare NHS Trust
  • Leeds, United Kingdom, LS1 3EX
    • Leeds General Infirmary
  • Leicester, United Kingdom, LE5 4PW
    • Glenfield Hospital
  • Wales, United Kingdom
    • University Hospital of Wales
  • Essex
    • Basildon, Essex, United Kingdom, SS16 5NL
      • Basildon and Thurrock University
  • Glasgow, Scotland
    • Clydebank, Glasgow, Scotland, United Kingdom, G81 4DY
      • Golden Jubilee Hospital,
  • Tooting
    • London, Tooting, United Kingdom, SW17 OQT
      • St George's Hospital, Blackshaw Road,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biosensors Microcatheter (BM); Use of Biosensors Microcatheter	Device: Microcatheter; Only to be used if Biosensor Microcatheter does not perform accordingly; Other Names: Standard hospital Microcatheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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	Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with device-related perforation	Device-related perforation at the site of target coronary lesion and/or its proximal reference segment including donor artery or collateral	Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.
Percentage of patients with device failure	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.	Follow-up only up to hospital discharge or 7 days maximum post procedure, whichever comes first.

Collaborators and Investigators

• Sponsor: Biosensors Europe SA
• Investigators: Principal Investigator: James Sprattt, Professor, St. George's Hospital, London; Principal Investigator: Margaret MCENTEGART, Dr., Golden Jubilee National Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2022
• Primary Completion (Actual): January 3, 2023
• Study Completion (Actual): January 3, 2023

Study Registration Dates

• First Submitted: June 30, 2021
• First Submitted That Met QC Criteria: July 7, 2021
• First Posted (Actual): July 19, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Total Occlusion (CTO); Microcatheter; CTO-PCI
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia
• Other Study ID Numbers: 20-EU-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: The emphasis in all scientific publications and presentations will be placed on the endpoint at discharge.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No