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
![Baseline characteristics Picture shows baseline characteristics](/sites/default/files/migrated_images/bio21869_553x368.jpg)
![ISR distribution by stent type Picture shows ISR distribution by stent type](/sites/default/files/migrated_images/bio21868_553x368.jpg)
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
![Study Design Picture shows study design](/sites/default/files/migrated_images/bio21866_553x368.jpg)
12-Month Results
![Study Results Picture shows study results](/sites/default/files/migrated_images/bio21871_1105x300.png)
Procedural Results
![Procedural Results Picture shows procedural results](/sites/default/files/migrated_images/bio21870_553x368.jpg)
Downloads
![Picture shows Pantera Lux](/sites/default/files/styles/site_width/public/migrated_images/bio14174_553x246.jpg?itok=w_QXr4VQ)
Vascular Intervention
Paclitaxel-Releasing BalloonClinically proven solution in both in-stent restenotic and de novo lesions
![Picture shows Pantera Lux](/sites/default/files/styles/site_width/public/migrated_images/bio09298_553x246.jpg?itok=ewMD_iUo)
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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