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CENTURY Trial

31/05/2013 -  

105 patients, single arm, primary endpoint: LL @6M. PCR 2013.

Low rate of adverse events up to 2 years.
No late and very late stent thrombosis.

Results

CENTURY - Primary Endpoint

Based upon estimated Kaname Late Loss
0.90±0.50 mm
0.50 mm improvement considered as clinically significant
Late loss of 0.40 mm (0.90-0.50 mm) is considered upper limit for Ultimaster DES

CENTURY - Primary Endpoint

Late Loss result:

  • Kaname : 0.75±0.43 mm
  • Ultimaster : 0.04±0.35 mm

Result: Ultimaster = SUPERIOR p<0.0001

 

Presented by Barbato E. MD, EuroPCR 2014
Barbato et al. Eurointervention. 2014 Aug 20. pii: 20140203-01. doi: 10.4244/EIJY14M08_06. [Epub ahead of print]

CENTURY - OCT Representative Images

Mean strut coverage (mm) 0.08 ± 0.04
% Covered Struts at 6 months96.2 ± 5.4
Malapposed struts, %1.66
Malapposition volume, mm31.86 ± 6.58

 

 

CENTURY - OCT Representative Images 

Presented by Barbato E. MD, EuroPCR 2013
Barbato et al. Eurointervention. 2014 Aug 20. pii: 20140203-01. doi: 10.4244/EIJY14M08_06. [Epub ahead of print]

CENTURY - Target Lesion Failure

Clinical Outcome @ 1 and 2 years

CENTURY - Target Lesion Failure

Follow-up = 100%
ST = 1 acute stent thrombosis due to a long untreated dissection

Low rate of adverse events up to 2 years
No late and very late stent thrombosis

 

Presented by Barbato E. MD, EuroPCR 2014
Barbato et al. Eurointervention. 2014 Aug 20. pii: 20140203-01. doi: 10.4244/EIJY14M08_06. [Epub ahead of print]

​Trial Design

CENTURY - Study Design

Prospective, multicentre, single arm clinical trial
Hypothesis: superiority vs. historical control of Kaname bare metal stent platform for late loss at 6m

CENTURY – Study Design

Primary endpoint LATE LOSS at 6 months

Main Inclusion Criteria:

  • Up to two de-novo lesions located in two epicardial vessels

Main Exclusion Criteria:

  • Left main CAD , CTO, ostial, bifurcation, SVG lesions
  • Prior PCI with stenting (within 1 month before enrolment)
  • STEMI <72h before procedure

 

PI: W. Wijns 8 sites in Europe