Clinical trial NCT01623180: A Randomized Clinical Evaluation of the BioFreedom™ Stent
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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Biosensors Europe SA
Sponsor class: INDUSTRY
Collaborators: name: European Cardiovascular Research Center
First posted: 2012-06-19
Enrollment: 2456
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

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).

Primary outcomes:
measure: Composite Safety Endpoint
timeFrame: one year
measure: Primary Efficacy Endpoint
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Meyrin
country: Switzerland
facility: Hôpital de la Tour
Study officials:
affiliation: Hôpital de la Tour
name: Philip Urban, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.