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Stable AnginaLeaders FreeNCT01623180

A Randomized Clinical Evaluation of the BioFreedom™ Stent

A study testing Biofreedom™ Drug Coated Stent (DCS) and Gazelle™ Bare Metal Coronary Stent (BMS) in people with Stable Angina and Ischemic Heart Disease Silent, run by Biosensors Europe SA at 1 site in Switzerland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biofreedom™ Drug Coated Stent (DCS) and Gazelle™ Bare Metal Coronary Stent (BMS)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,456 participants
Where
1 siteSwitzerland
Study dates
Dec 2012to Jun 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Hôpital de la Tour

    Meyrin, 1217

Other trials in Switzerland

About this study

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.

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.

Being tested
Biofreedom™ Drug Coated Stent (DCS), Gazelle™ Bare Metal Coronary Stent (BMS)
Keywords
DES, coronary stent, bare metal stent, high bleeding, MI, angina
Medical subject headings
Angina, Stable, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Myocardial Infarction, Hemorrhage, Angina Pectoris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biofreedom™ Drug Coated Stent (DCS)Device

    Also called Drug coated stent

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

  • Gazelle™ Bare Metal Coronary Stent (BMS)Device

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

Study groups in NCT01623180
Study groupRoleWhat they receive
BioFreedom™ Drug Coated Stent (DCS)ExperimentalBA9 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.
Receives: Device: Biofreedom™ Drug Coated Stent (DCS)
Gazelle™ Bare Metal Coronary Stent (BMS)Active comparatorGAZELLE™ 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.
Receives: Device: Gazelle™ Bare Metal Coronary Stent (BMS)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite Safety Endpoint

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

    Measured: one year

  2. Primary Efficacy Endpoint

    The incidence of clinically driven target lesion revascularization

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2012 (estimated)
  2. Study startDec 2012
  3. Primary completionMay 2015
  4. Study completionJun 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,456 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01623180
Sponsor's protocol ID
12EU01
Acronym
Leaders Free
Status last verified
Aug 2015
First submitted
5 Jun 2012
Last updated
19 Aug 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 38626080

  • 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.

    PubMed 29951803

  • 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.

    PubMed 28838473

  • 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.

    PubMed 27806919

  • 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.

    PubMed 26466021

  • 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.

    PubMed 23622906

Questions about this trial

What is this clinical trial studying?

A study testing Biofreedom™ Drug Coated Stent (DCS) and Gazelle™ Bare Metal Coronary Stent (BMS) in people with Stable Angina and Ischemic Heart Disease Silent, run by Biosensors Europe SA at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite Safety Endpoint (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01623180, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2015.

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