NCT02843633

LEADERS FREE II: BioFreedom™ Pivotal Study

A Prospective Study of the BioFreedom™ Biolimus A9™ Drug Coated Stent in Patients at High Risk for Bleeding

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,203 (actual)
• Sponsor: Biosensors Europe SA · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This study aims to confirm non-inferiority of the BioFreedom™ Drug Coated Stent to the Gazelle™ Bare Metal Stent arm of the Leaders Free study (NCT01623180) in high bleeding risk patients.

Detailed description

In this study all patients will receive the BioFreedom™ Drug Coated Stent and one month of Dual Anti Platelet Therapy

Conditions

• Acute Coronary Syndrome
• High Bleeding Risk

Interventions

Type	Name	Description
DEVICE	BioFreedom™ Drug Coated Coronary Stent System	a non-surgical procedure that uses a catheter to place a stent to open up coronary arteries that have been narrowed by atherosclerosis
DRUG	Antiplatelet Drug	Dual antiplatelet therapy for one month followed by single antiplatelet therapy indefinitely. Aspirin and clopidogrel (or other P2Y12 inhibitor) will be used and dosing is according to standard institutional practice

Timeline

• Start date: 2017-02-14
• Primary completion: 2018-10-11
• Completion: 2021-03-01
• First posted: 2016-07-26
• Last updated: 2021-02-03

Locations

66 sites across 7 countries: United States, Canada, Denmark, France, Germany, Italy, United Kingdom

Regulatory

• FDA-regulated device study