DELUX

DELUX Registry

NCT01081366

Drug-Releasing Pantera Lux PTCA Balloon Catheter Registry

Conclusion

  • Treatment with the Pantera Lux paclitaxel-coated balloon showed good 12-month outcomes in an international real-world setting in a predominantly difficult in-stent restenosis (ISR) population.
  • Efficacy and safety are demonstrated by low revascularization, myocardial infarction (MI) and cardiac death rates and confirm previous clinical results of this device using butyryl-tri-hexyl citrate (BTHC) as an inert excipient.
  • Results are favorable both in the overall population and in the de novo lesion subgroup.

Baseline Characteristics and ISR Distribution by Stent Type

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Picture shows baseline characteristics
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Picture shows ISR distribution by stent type

Study Design

  • Prospective, multi-center international registry
  • Number of patients (n): 1,064
  • Principal investigator: Dr. Ralph Tölg, Herzzentrum Segeberger Kliniken, Bad Segeberg, Germany
  • Clinical Sites: 62 sites in 12 countries
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Picture shows study design

12-Month Results

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Picture shows study results

Procedural Results

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Picture shows procedural results

Downloads


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Picture shows Pantera Lux

Vascular Intervention

Paclitaxel-Releasing Balloon


Clinically proven solution in both in-stent restenotic and de novo lesions

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Picture shows Pantera Lux

Vascular Intervention

Clinical Study

Optimizing treatment of drug-eluting stent in-stent restenosis 4


1 Defined as successful deployment of device and < 50% residual stenosis of target lesion by visual estimation
2 Hierarchical MACE, composite of all death, non-fatal MI and clinically driven target vessel revascularization (TVR), adjudicated by clinical events committee

Source:
Tölg R. EuroIntervention. 2014; 10(5): 591-9.

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