NCT01623180

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,456

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 5, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 19, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

2.4 years

First QC Date

June 5, 2012

Last Update Submit

August 17, 2015

Conditions

Stable AnginaIschemic Heart Disease SilentST Elevation (STEMI) and Non-ST Elevation (NSTEMI) Myocardial InfarctionIn-stent Coronary Artery RestenosisBleeding

Keywords

DEScoronary stentbare metal stenthigh bleedingMIangina

Outcome Measures

Primary Outcomes (2)

  • Composite Safety Endpoint

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

    one year

  • Primary Efficacy Endpoint

    The incidence of clinically driven target lesion revascularization

    one year

Study Arms (2)

BioFreedom™ Drug Coated Stent (DCS)

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.

Device: Biofreedom™ Drug Coated Stent (DCS)

Gazelle™ Bare Metal Coronary Stent (BMS)

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.

Device: Gazelle™ Bare Metal Coronary Stent (BMS)

Interventions

Biofreedom™ Drug Coated Stent (DCS)DEVICE

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

Also known as: Drug coated stent
BioFreedom™ Drug Coated Stent (DCS)
Gazelle™ Bare Metal Coronary Stent (BMS)DEVICE

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

Gazelle™ Bare Metal Coronary Stent (BMS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital de la Tour

Meyrin, 1217, Switzerland

Location

Related Publications (6)

  • Campos CM, Mehran R, Capodanno D, Owen R, Windecker S, Varenne O, Stone GW, Valgimigli M, Hajjar LA, Kalil Filho R, Oldroyd K, Morice MC, Urban P, Abizaid A. Risk Burden of Cancer in Patients Treated With Abbreviated Dual Antiplatelet Therapy After PCI: Analysis of Multicenter Controlled High-Bleeding Risk Trials. Circ Cardiovasc Interv. 2024 Apr;17(4):e013000. doi: 10.1161/CIRCINTERVENTIONS.122.013000. Epub 2024 Apr 16.

    PMID: 38626080DERIVED

  • 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.

    PMID: 29951803DERIVED

  • 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.

    PMID: 28838473DERIVED

  • 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.

    PMID: 27806919DERIVED

  • 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.

    PMID: 26466021DERIVED

  • 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.

    PMID: 23622906DERIVED

MeSH Terms

Conditions

Angina, StableST Elevation Myocardial InfarctionNon-ST Elevated Myocardial InfarctionMyocardial InfarctionHemorrhageAngina Pectoris

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsInfarctionIschemiaPathologic ProcessesNecrosis

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Officials

  • Philip Urban, MD

    Hôpital de la Tour

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2012

First Posted

June 19, 2012

Study Start

December 1, 2012

Primary Completion

May 1, 2015

Study Completion

June 1, 2016

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

CH(1)