A Randomized Clinical Evaluation of the BioFreedom™ Stent (Leaders Free)

Biosensors International

Status: Unknown

Conditions: Stable Angina; Ischemic Heart Disease Silent; ST Elevation (STEMI) and Non-ST Elevation (NSTEMI) Myocardial Infarction; In-stent Coronary Artery Restenosis; Bleeding

Treatments: Device: Gazelle™ Bare Metal Coronary Stent (BMS); Device: Biofreedom™ Drug Coated Stent (DCS)

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT01623180

12EU01

Details and patient eligibility

About

The purpose of this study is to demonstrate that a BioFreedom™ Drug Coated Stent is non-inferior to a bare metal stent at one year as measured by the composite safety endpoint of cardiovascular death, myocardial infarction and definite/probable stent thrombosis, and that its efficacy is superior to a bare metal stent as measured by clinically driven TLR at one year.

Enrollment: 2,456 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any indication for PCI-S in patients deemed at high risk for bleeding and candidates for 1 month 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.

Exclusion criteria

1. Pregnancy
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 planned to require non-study stents, or stand alone POBA or stand-alone atherectomy
5. Active bleeding at the time of inclusion
6. Reference vessel diameter <2.25 - >4.0mm
7. Cardiogenic shock
8. Compliance with long-term single anti-platelet therapy unlikely
9. A known hypersensitivity or contraindication to aspirin, clopidogrel (or prasugrel, or ticagrelor if applicable), stainless steel, Biolimus A9 or a sensitivity to contrast media, which cannot be adequately pre-medicated.
10. Participation in another clinical trial (12 months after index procedure).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,456 participants in 2 patient groups

BioFreedom™ Drug Coated Stent (DCS)

Experimental group

Description:

BA9 drug coated stent implantation for improving coronary luminal diameter in patients with de novo lesions in native coronary arteries with a reference vessel diameter between 2.25 mm and 4.0 mm.

Treatment:

Device: Biofreedom™ Drug Coated Stent (DCS)

Gazelle™ Bare Metal Coronary Stent (BMS)

Active Comparator group

Description:

GAZELLE™ bare metal stent implantation for improving coronary luminal diameter in patients with de novo lesions in native coronary arteries with a reference vessel diameter between 2.25 and 4.0 mm.

Treatment:

Device: Gazelle™ Bare Metal Coronary Stent (BMS)