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

Ischemic Heart Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04966273
• Other study ID #: 20-EU-01
• Status: Completed
• Phase: N/A
• Start date: March 18, 2022
• Est. completion date: January 3, 2023

Study information

• Verified date: January 2023
• Source: Biosensors Europe SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 segment), respectively.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: January 3, 2023
• Est. primary completion date: January 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Device:
• Microcatheter
Only to be used if Biosensor Microcatheter does not perform accordingly

Locations

Country	Name	City	State
United Kingdom	Basildon and Thurrock University	Basildon	Essex
United Kingdom	Royal Victoria Hospital	Belfast
United Kingdom	Bristol Heart Institute, UHBW NHS Trust	Bristol
United Kingdom	Golden Jubilee Hospital,	Clydebank	Glasgow, Scotland
United Kingdom	London North West University Healthcare Nhs Trust	Harrow
United Kingdom	Leeds General Infirmary	Leeds
United Kingdom	Glenfield Hospital	Leicester
United Kingdom	St George's Hospital, Blackshaw Road,	London	Tooting
United Kingdom	University Hospital of Wales	Wales

Sponsors (1)

Lead Sponsor	Collaborator
Biosensors Europe SA

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Other	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.