PEPPER

PEPPER

NCT00961181

First-In-Human Trial - Paclitaxel-Releasing Balloon in Patients Presenting with In-Stent Restenosis

Conclusion

  • Application of a paclitaxel-coated balloon using butyryl-tri-hexyl citrate (BTHC) as an excipient is feasible and safe in a mixed population of patients with predominantly type I bare metal stent (BMS) or drug-eluting stent (DES) in-stent restenosis (ISR) lesion.
  • A short exposure of the vessel wall to paclitaxel results in very low late lumen loss, revascularization and major adverse cardiac events (MACE) rates.
  • Pantera Lux application is a valuable treatment option for ISR in both BMS and DES patients.

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, non-randomized European clinical trial
  • Number of patients (n): 81
  • Principal Investigator: Dr. Chistoph Hehrlein, University Medical Center Freiburg, Germany
  • Primary endpoint: In-stent late lumen loss (LLL) at 6 months
  • Clinical sites: 9 sites in Germany, Poland and Denmark
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Picture shows study design

Acute and 6-months Angiographic Results

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Picture shows angiographic study results

6 and 12-Month Clinical Results

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Picture shows clinical results

Downloads


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Picture shows Pantera Lux

Vascular Intervention

Paclitaxel-Releasing BalloonClinically proven solution in both in-stent restenotic and de novo lesions

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Picture shows Pantera Lux

Vascular Intervention

Clinical StudyDrug-Releasing Pantera Lux PTCA Balloon Catheter Registry


Source:
Hehrlein C et al. Cardiovasc Revasc Med. 2012; 13(5): 260-4.

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