NCT02400632

MagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions

Assessment of the Novel MagicTouch Sirolimus Drug Coated Balloon Catheter for the Treatment of Coronary Lesions

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Scitech Produtos Medicos SA · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate the efficacy of MagicTouch DCB in reducing late lumen loss / suppressing neointimal tissue formation as assessed by Quantitative Coronary Angiography / Intravascular Ultrasound examination for the treatment of coronary artery lesions ranging from 3.0 mm to 3.5 mm of diameter and lesion length ≤ 15 mm.

Detailed description

Prospective, multicenter, randomized study designed to enroll 60 subjects with In-stent Restenosis, To demonstrate the efficacy of MagicTouch Drug-Coated Balloon in reducing late lumen loss / suppressing neointimal tissue formation as assessed by Quantitative Coronary Angiography / Intravascular Ultrasound examination for the treatment of coronary artery lesions ranging from 3.0 mm to 3.5 mm of diameter and lesion length ≤ 15 mm.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	MAGIC-TOUCH Drug-eluting Balloon	in-stent restenosis treated with drug eluting balloon

Timeline

• Start date: 2015-06-01
• Primary completion: 2019-07-30
• Completion: 2019-12-30
• First posted: 2015-03-27
• Last updated: 2020-03-17

Locations

3 sites across 1 country: Brazil