A Randomized Clinical Evaluation of the BioFreedom™ Stent

Bleeding Clinical Trial

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Official title:

A Prospective Randomized Comparison of the BioFreedom Biolimus A9 Drug Coated Stent Versus the Gazelle Bare Metal Stent in Patients With High Risk of Bleeding.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01623180
• Other study ID #: 12EU01
• Status: Active, not recruiting
• Phase: N/A
• First received: June 5, 2012
• Last updated: August 17, 2015
• Start date: December 2012
• Est. completion date: June 2016

Study information

• Verified date: August 2015
• Source: Biosensors Europe SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: SwissMedic: Institut suisse des produits thérapeutiques • Hallerstrasse 7 • Case postale • CH-3000 Berne 9 Tél. +41 31 322 02 11 • Fax +41 31 322 02 12
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2456
• Est. completion date: June 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angina, Stable
• Bleeding
• Coronary Artery Disease
• Coronary Restenosis
• Hemorrhage
• In-stent Coronary Artery Restenosis
• Ischemic Heart Disease Silent
• Myocardial Infarction
• Myocardial Ischemia
• ST Elevation (STEMI) and Non-ST Elevation (NSTEMI) Myocardial Infarction
• Stable Angina

Intervention

Device:
• Biofreedom™ Drug Coated Stent (DCS)
Biofreedom DCS implantation in high risk bleeding patients followed by 1 month DAPT
• Gazelle™ Bare Metal Coronary Stent (BMS)
Gazelle BMS implantation in high risk bleeding patients followed by 1 month DAPT

Locations

Country	Name	City	State
Switzerland	Hôpital de la Tour	Meyrin

Sponsors (2)

Lead Sponsor	Collaborator
Biosensors Europe SA	European Cardiovascular Research Center

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite Safety Endpoint	Composite of cardiac death, myocardial infarction and definite/probable stent thrombosis at one year	one year	Yes
Primary	Primary Efficacy Endpoint	The incidence of clinically driven target lesion revascularization	one year	No