Leaders Free III: BioFreedom™ Clinical Trial

Myocardial Infarction Clinical Trial

Official title:

A Study Evaluating the Safety and Efficacy of the BioFreedom™ Biolimus A9™ Coated Cobalt Chromium Coronary Stent System in Patients at High Risk of Bleeding

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03118895
• Other study ID #: 17EU01
• Status: Completed
• Phase: N/A
• Start date: November 8, 2017
• Est. completion date: November 18, 2022

Study information

• Verified date: February 2024
• Source: Biosensors Europe SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study evaluating the safety and efficacy of the BioFreedom™ Biolimus A9™ coated Cobalt Chromium coronary stent system in patients at high risk of bleeding

Description:

Prospective, multi-center, open-label single-arm study designed to enroll 370 HBR patients (for at least 340 evaluable) at up to 20 centers in up to 2 European countries. 370 patients will receive a BioFreedomTM CoCr stent. All patients will be followed up for 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 404
• Est. completion date: November 18, 2022
• Est. primary completion date: September 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

• Patients at high bleeding risk (HBR) with an indication for percutaneous coronary intervention who can tolerate no more than one month of DAPT. This includes candidates with stable angina, silent ischemia, ACS (STEMI and non-STEMI), non-native lesions and in-stent restenosis. Patients must provide written informed consent.

Reasons of unsuitability for > 1 month dual antiplatelet treatment must include one or MORE of the following:

1. Adjunctive oral anticoagulation treatment planned to continue after PCI

2. Age = 75 years old

3. Baseline Hgb <11 g/dl (or anemia requiring transfusion during the 4 weeks prior to inclusion into the trial)

4. Any prior intracerebral bleed

5. Any stroke in the last 12 months

6. Hospital admission for bleeding during the prior 12 months

7. Non skin cancer diagnosed or treated = 3 years

8. Planned daily NSAID (other than aspirin) or steroids for = 30 days after PCI

9. Planned surgery that would require interruption of DAPT (within next 12 months)

10. Renal failure defined as: Creatinine clearance <40 ml/min

11. Thrombocytopenia (PLT <100,000/mm3)

12. Severe chronic liver disease defined as: patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice

13. Expected non-compliance to prolonged DAPT for other medical reasons

Exclusion Criteria:

1. Pregnant and breastfeeding women

2. Patients expected not to comply with 1 month DAPT

3. Patients requiring a planned staged PCI procedure more than one week after the index procedure

4. Procedure requires the use of non-study stents, or alternative therapeutic options not followed by stent implantation (angioplasty only, atherectomy only).

5. Active bleeding at the time of inclusion

6. If patient requires a stent <2.5mm

7. If patient requires a stent >3.5mm

8. Cardiogenic shock

9. Compliance with long-term single anti-platelet therapy unlikely

10. Known hypersensitivity or contraindication to aspirin, clopidogrel (or to any another P2Y12 inhibitor if applicable), cobalt chromium, zinc, Biolimus A9TM or a sensitivity to contrast media, which cannot be adequately pre-medicated

11. PCI during the previous 12 months for a lesion other than the target lesion

12. Participation in another clinical trial (12 months after index procedure)

13. Patients with a life expectancy of < 1 year

Related Conditions & MeSH terms

• Bleeding
• Cardiac Death
• Death
• Hemorrhage
• Infarction
• Mortality
• Myocardial Infarction
• Stent Thrombosis
• Thrombosis

Intervention

Device:
• BioFreedom™ BA9™ drug-coated stent
Drug-coated stent for coronary arteries

Locations

Country	Name	City	State
France	at Hôpital Privé Claude Galien ICPS	Quincy sous Sénart	Essonne
Switzerland	Triemli Stadtspital	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Biosensors Europe SA	European Cardiovascular Research Center

Countries where clinical trial is conducted

France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MACE: composite of cardiac death, myocardial infarction and definite/probable stent thrombosis (safety)	Incidence	at 1 year
Primary	clinically driven target lesion revascularization (efficacy)	incidence	at 1 year
Secondary	All-cause mortality	incidence	At 1 and 4 months, and 1 and 2 years
Secondary	Clinically Driven Target Lesion Revascularization	Incidence	At 1 and 4 months, and 2 years
Secondary	Clinically Driven Target Vessel Revascularization	Incidence	At 1 and 4 months, and 2 years