CONCLUSION

This preliminary analysis shows the Magic Touch Sirolimus eluting balloon :
• Is safe with low device related events rates
• Is efficatious with low TLR and low late loss

  • Principal Investigator
    Alexandre Abizaid
    Instituto Dante Pazzanese de Cardilogia, Sao Paulo, Brazil
STUDY DETAILS

• To demonstrate the safety and efficacy of Drug Coated Balloon Magic Touch in reducing late luminal loss / suppression of neointimal tissue formation, assessed by intravascular ultrasound, in the treatment of intra-stent restenosis.
• Lesions with a diameter of > 3.0mm to <3.5mm and a length of <20mm.
• A prospective, multicenter, single arm study designed to include 30 patients.
• Angiographic follow-up will be performed in all patients at 6 months.
• Clinical follow-up at 30 days, 6 months and 12 months.
• Evaluation by IVUS at 6 months

STUDY ENDPOINTS

Primary Endpoints:
The percentage (%) of intra-stent formation of neointimal tissue will be assessed by IVUS at 6 months.

Secondary Endpoints:
Binary restenosis during angiographic follow-up of performed at 6 months;
Vascular complications from index procedure to hospital discharge;
Target lesion failure (TLF), defined as death, MI and ischemic revascularization of the target lesion at 30 days, 6 months and 12 months.

BASELINE AND LESION CHARACTERISTICS
CLINICAL OUTCOMES
QCA RESULTS @ 6 MONTHS