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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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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12-Month Results
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Procedural Results
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Vascular Intervention
Paclitaxel-Releasing BalloonClinically proven solution in both in-stent restenotic and de novo lesions
Vascular Intervention
Clinical StudyOptimizing 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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