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

Primary Purpose

Stable Angina, Ischemic Heart Disease Silent, ST Elevation (STEMI) and Non-ST Elevation (NSTEMI) Myocardial Infarction

Status

Unknown status

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

Biofreedom™ Drug Coated Stent (DCS)

Gazelle™ Bare Metal Coronary Stent (BMS)

About this trial

This is an interventional treatment trial for Stable Angina focused on measuring DES, coronary stent, bare metal stent, high bleeding, MI, angina

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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:

Pregnancy
Patients expected not to comply with 1 month DAPT
Patients requiring a planned staged PCI procedure more than one week after the index procedure
Procedure planned to require non-study stents, or stand alone POBA or stand-alone atherectomy
Active bleeding at the time of inclusion
Reference vessel diameter <2.25 - >4.0mm
Cardiogenic shock
Compliance with long-term single anti-platelet therapy unlikely
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.
Participation in another clinical trial (12 months after index procedure).

Sites / Locations

Hôpital de la Tour

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BioFreedom™ Drug Coated Stent (DCS)

Gazelle™ Bare Metal Coronary Stent (BMS)

Arm 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.

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.

Outcomes

Primary Outcome Measures

Composite Safety Endpoint

Composite of cardiac death, myocardial infarction and definite/probable stent thrombosis at one year

Primary Efficacy Endpoint

The incidence of clinically driven target lesion revascularization

Secondary Outcome Measures

Full Information

NCT ID

NCT01623180

First Posted

June 5, 2012

Last Updated

August 17, 2015

Sponsor

Biosensors Europe SA

Collaborators

European Cardiovascular Research Center

1. Study Identification

Unique Protocol Identification Number

NCT01623180

Brief Title

A Randomized Clinical Evaluation of the BioFreedom™ Stent

Acronym

Leaders Free

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

December 2012 (undefined)

Primary Completion Date

May 2015 (Actual)

Study Completion Date

June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biosensors Europe SA

Collaborators

European Cardiovascular Research Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

DES, coronary stent, bare metal stent, high bleeding, MI, angina

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2456 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BioFreedom™ Drug Coated Stent (DCS)

Arm Type

Experimental

Arm 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.

Arm Title

Gazelle™ Bare Metal Coronary Stent (BMS)

Arm Type

Active Comparator

Arm 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.

Intervention Type

Device

Intervention Name(s)

Biofreedom™ Drug Coated Stent (DCS)

Other Intervention Name(s)

Drug coated stent

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Gazelle™ Bare Metal Coronary Stent (BMS)

Intervention Description

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

Primary Outcome Measure Information:

Title

Composite Safety Endpoint

Description

Composite of cardiac death, myocardial infarction and definite/probable stent thrombosis at one year

Time Frame

one year

Title

Primary Efficacy Endpoint

Description

The incidence of clinically driven target lesion revascularization

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: Pregnancy Patients expected not to comply with 1 month DAPT Patients requiring a planned staged PCI procedure more than one week after the index procedure Procedure planned to require non-study stents, or stand alone POBA or stand-alone atherectomy Active bleeding at the time of inclusion Reference vessel diameter <2.25 - >4.0mm Cardiogenic shock Compliance with long-term single anti-platelet therapy unlikely 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. Participation in another clinical trial (12 months after index procedure).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Philip Urban, MD

Organizational Affiliation

Hôpital de la Tour

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital de la Tour

City

Meyrin

ZIP/Postal Code

1217

Country

Switzerland

12. IPD Sharing Statement

Citations:

PubMed Identifier

29951803

Citation

Richardt G, Maillard L, Nazzaro MS, Abdel-Wahab M, Carrie D, Iniguez A, Garot P, Abdellaoui M, Morice MC, Foley D, Copt S, Stoll HP, Urban P. Polymer-free drug-coated coronary stents in diabetic patients at high bleeding risk: a pre-specified sub-study of the LEADERS FREE trial. Clin Res Cardiol. 2019 Jan;108(1):31-38. doi: 10.1007/s00392-018-1308-1. Epub 2018 Jun 27.

Results Reference

derived

PubMed Identifier

28838473

Citation

Carrie D, Menown I, Oldroyd K, Copt S, Talwar S, Maillard L, Morice MC, Teik LS, Lang I, Urban P. Safety and Efficacy of Polymer-Free Biolimus A9-Coated Versus Bare-Metal Stents in Orally Anticoagulated Patients: 2-Year Results of the LEADERS FREE Oral Anticoagulation Substudy. JACC Cardiovasc Interv. 2017 Aug 28;10(16):1633-1642. doi: 10.1016/j.jcin.2017.05.033.

Results Reference

derived

PubMed Identifier

27806919

Citation

Garot P, Morice MC, Tresukosol D, Pocock SJ, Meredith IT, Abizaid A, Carrie D, Naber C, Iniguez A, Talwar S, Menown IBA, Christiansen EH, Gregson J, Copt S, Hovasse T, Lurz P, Maillard L, Krackhardt F, Ong P, Byrne J, Redwood S, Windhovel U, Greene S, Stoll HP, Urban P; LEADERS FREE Investigators. 2-Year Outcomes of High Bleeding Risk Patients After Polymer-Free Drug-Coated Stents. J Am Coll Cardiol. 2017 Jan 17;69(2):162-171. doi: 10.1016/j.jacc.2016.10.009. Epub 2016 Oct 30.

Results Reference

derived

PubMed Identifier

26466021

Citation

Urban P, Meredith IT, Abizaid A, Pocock SJ, Carrie D, Naber C, Lipiecki J, Richardt G, Iniguez A, Brunel P, Valdes-Chavarri M, Garot P, Talwar S, Berland J, Abdellaoui M, Eberli F, Oldroyd K, Zambahari R, Gregson J, Greene S, Stoll HP, Morice MC; LEADERS FREE Investigators. Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk. N Engl J Med. 2015 Nov 19;373(21):2038-47. doi: 10.1056/NEJMoa1503943. Epub 2015 Oct 14.

Results Reference

derived

PubMed Identifier

23622906

Citation

Urban P, Abizaid A, Chevalier B, Greene S, Meredith I, Morice MC, Pocock S. Rationale and design of the LEADERS FREE trial: A randomized double-blind comparison of the BioFreedom drug-coated stent vs the Gazelle bare metal stent in patients at high bleeding risk using a short (1 month) course of dual antiplatelet therapy. Am Heart J. 2013 May;165(5):704-9. doi: 10.1016/j.ahj.2013.01.008. Epub 2013 Feb 19.

Results Reference

derived

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A Randomized Clinical Evaluation of the BioFreedom™ Stent

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