NCT02891005

Comparing the Safety and Efficacy of Paclitaxel Controlled Release Balloon Catheter (VasoguardTM) in the Treatment of Small Coronary Vessel Stenosis With a Common Coronary Balloon Catheter (Maverick2)

A Multicenter, Prospective and Randomized Controlled Clinical Study (VasoguardTM Trial I) That Comparing the Safety and Efficacy of Paclitaxel Controlled Release Balloon Catheter (VasoguardTM) in the Treatment of Small Coronary Vessel Stenosis With a Common Coronary Balloon Catheter (Maverick2)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (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 VasoguardTM in treatment of small vessel lesion. Study Group Experimental group: paclitaxel controlled release balloon catheter (VasoguardTM) Control group: common balloon catheter (Maverick2)

Conditions

• Small Vessel Lesion

Interventions

Type	Name	Description
DEVICE	paclitaxel controlled release balloon catheter (VasoguardTM)	paclitaxel controlled release balloon catheter implantation for small vessel lesion
DEVICE	common balloon catheter (Maverick2)	common balloon catheter implantation for small vessel lesion

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