Overview

This trial is active, not recruiting.

Conditions stable angina, ischemic heart disease silent, st elevation (stemi) and non-st elevation (nstemi) myocardial infarction, in-stent coronary artery restenosis, bleeding
Treatments biofreedom™ drug coated stent (dcs), gazelle™ bare metal coronary stent (bms)
Sponsor Biosensors Europe SA
Collaborator European Cardiovascular Research Center
Start date December 2012
End date May 2015
Trial size 2456 participants
Trial identifier NCT01623180, 12EU01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
biofreedom™ drug coated stent (dcs) Drug coated stent
Biofreedom DCS implantation in high risk bleeding patients followed by 1 month DAPT
(Active Comparator)
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.
gazelle™ bare metal coronary stent (bms)
Gazelle BMS implantation in high risk bleeding patients followed by 1 month DAPT

Primary Outcomes

Measure
Composite Safety Endpoint
time frame: one year
Primary Efficacy Endpoint
time frame: one year

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

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.
Principal investigator Philip Urban, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Biosensors Europe SA.