A Randomized Clinical Evaluation of the BioFreedom™ Stent

Not Applicable

• Conditions: ST Elevation (STEMI) and Non-ST Elevation (NSTEMI) Myocardial Infarction; In-stent Coronary Artery Restenosis; Ischemic Heart Disease Silent; Stable Angina; Bleeding
• Interventions: Device: Biofreedom™ Drug Coated Stent (DCS); Device: Gazelle™ Bare Metal Coronary Stent (BMS)

• Registration Number: NCT01623180
• Lead Sponsor: Biosensors Europe SA

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-05
• Study First Submitted QC: 2012-06-15
• Study First Posted: 2012-06-19
• Study Start: 2012-12
• Primary Completion: 2015-05
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-19
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2456

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BioFreedom™ Drug Coated Stent (DCS)	Biofreedom™ Drug Coated Stent (DCS)	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.
Gazelle™ Bare Metal Coronary Stent (BMS)	Gazelle™ Bare Metal Coronary Stent (BMS)	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.

Primary Outcome Measures

Name	Time	Method
Composite Safety Endpoint	one year	Composite of cardiac death, myocardial infarction and definite/probable stent thrombosis at one year
Primary Efficacy Endpoint	one year	The incidence of clinically driven target lesion revascularization

Trial Locations

Locations (1)

Hôpital de la Tour; 🇨🇭 Meyrin, Switzerland