Individual Study / Waksman et al.; Cardiovasc Revasc Med. 2017

Polymer-free Biolimus A9-coated Stents in the Treatment of De Novo Coronary Lesions With Short DAPT: 9-month Angiographic and Clinical Follow-Up of the Prospective, Multicenter BioFreedom USA Clinical Trial

Polymer-free Biolimus A9-coated Stents in the Treatment of De Novo Coronary Lesions With Short DAPT: 9-month Angiographic and Clinical Follow-Up of the Prospective, Multicenter BioFreedom USA Clinical Trial

Initiatives -
The purpose was to evaluate the efficacy and safety of this DCS in patients with short-duration dual antiplatelet therapy. Note: All published information has been collected from the article referenced in the Marker Paper box below. Therefore, there may be variations with more advanced versions of the study.
Start Year
2007

Design

Study design
Clinical trial cohort

Marker Paper

Waksman R, Piegari GN, Kabour A, et al. Polymer-free Biolimus A9-coated stents in the treatment of de novo coronary lesions with short DAPT: 9-month angiographic and clinical follow-up of the prospective, multicenter BioFreedom USA clinical trial. Cardiovasc Revasc Med. 2017;18(7):475‐481. doi:10.1016/j.carrev.2017.07.017 Format:

PUBMED 28923692

Recruitment

Sources of Recruitment
  • Individuals

Number of participants

Number of participants
182
Number of participants with biosamples

Access

Availability of data and biosamples

Data
Biosamples
Other

Timeline

Population

A total of 182 patients were enrolled between September 2008 and June 2009 at 4 sites in Germany; the first 75 randomized patients were allocated in Cohort 1, and the subsequent 107 randomized patients were allocated in Cohort 2. T
Selection Criteria
Newborns
Twins
Countries
  • Germany
Ethnic Origin
Health Status
  • patients with de novo coronary lesions

Recruitment

Sources of recruitment
  • Clinical patients

Number of participants

Number of participants
182
Number of participants with biosamples
Data Collection Event
The purpose of this study was to evaluate the efficacy and long-term outcomes of a novel polymer/carrier-free drug-coated stent (DCS) in patients with de novo coronary lesions.
Start Date
2008-09
End Date
2009-06
Data sources
  • Smart sensors
    • Biosensors