NCT02891018

Comparing the Safety and Efficacy of Paclitaxel Controlled Release Balloon Catheter in the Treatment of In-stent Restenosis of Coronary Artery Lesion With Paclitaxel Release Coronary Balloon Catheter

A Multicenter, Prospective and Randomized Controlled Clinical Study (VasoguardTM Trial II) That Comparing the Safety and Efficacy of Paclitaxel Controlled Release Balloon Catheter (VasoguardTM) in the Treatment of In-stent Restenosis of Coronary Artery Lesion With Paclitaxel Release Coronary Balloon Catheter (SeQuent Please)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Shandong Branden Med.Device Co.,Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Study purpose The safety and efficacy of paclitaxel controlled release balloon catheter Vasoguard TM in treatment of in-stent restenosis. Study group Experimental group: paclitaxel controlled release balloon catheter Vasoguard TM Control group: paclitaxel release coronary balloon catheter SeQuent Please

Conditions

• In-stent Restenosis

Interventions

Type	Name	Description
DEVICE	paclitaxel controlled release balloon catheter Vasoguard TM
DEVICE	paclitaxel release coronary balloon catheter SeQuent Please

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-12-01
• First posted: 2016-09-07
• Last updated: 2016-09-09

Locations

1 site across 1 country: China