ISAR-DESIRE 4

ISAR-DESIRE 4

Randomized Clinical Trial

Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug-Eluting Stent In-Stent Restenosis 4

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Conclusion

  • In patients presenting with drug-eluting stent (DES) restenosis paclitaxel-coated balloon-based strategies confirmed a high clinical safety profile out to 1 year
  • In patients presenting with DES restenosis neointimal modification with scoring balloon significantly improves the angiographic antirestenotic efficacy of paclitaxel-coated balloon angioplasty

Study Design

Prospective, randomized, active, controlled multi-center clinical trial to compare the anti-restenotic efficacy of scoring balloon (SCB) pre-dilation before drug-coated balloon (DCB) therapy versus standard balloon pre-dilation (Plain Old Balloon Angioplasty, POBA) before DCB therapy in patients with limus-eluting stent (LES) restenosis. Baseline characteristics were not significantly different in the two groups.

  • Number of patients (n): 252
  • Principal investigator: Dr. Robert Byrne, German Heart Center, Munich, Germany
  • Primary endpoint: Percent diameter stenosis (%DS) at 6-8 months
  • Secondary endpoints: binary restenosis, Target Lesion Revascularization (TLR), death/myocardial infarction (MI), target lesion thrombosis
Picture shows study design

Results

Picture shows primary endpoint results
Picture shows secondary endpoint results

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ISAR-DESIRE 4 Clinical Study Flyer
Picture shows Pantera Lux

Vascular Intervention

Pantera Lux

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

Picture shows Pantera Lux

Vascular Intervention

PEPPER

Clinical StudyPaclitaxel Releasing Balloon in patients presenting with in-stent restenosis – First-in-Human

Source:
Byrne R. Presentation at TCT 2015.

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