A Randomized Clinical Evaluation of the BioFreedom™ Stent

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

2456 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Biofreedom™ Drug Coated Stent (DCS)

Intervention Type DEVICE

Biofreedom DCS implantation in high risk bleeding patients followed by 1 month DAPT

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.

Group Type ACTIVE_COMPARATOR

Gazelle™ Bare Metal Coronary Stent (BMS)

Intervention Type DEVICE

Gazelle BMS implantation in high risk bleeding patients followed by 1 month DAPT

Interventions

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Biofreedom™ Drug Coated Stent (DCS)

Biofreedom DCS implantation in high risk bleeding patients followed by 1 month DAPT

Intervention Type DEVICE

Gazelle™ Bare Metal Coronary Stent (BMS)

Gazelle BMS implantation in high risk bleeding patients followed by 1 month DAPT

Intervention Type DEVICE

Other Intervention Names

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Drug coated stent

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No