ISAR-DESIRE 4

ISAR-DESIRE 4

Randomized Clinical Trial

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

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
圖片
Picture shows study design

Results

圖片
Picture shows primary endpoint results
圖片
Picture shows secondary endpoint results

Downloads


Picture shows Pantera Lux

Vascular Intervention

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

Picture shows Pantera Lux

Vascular Intervention

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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