NCT04213378

Evaluation of the Efficacy and Safety of a Paclitaxel Eluting PTCA Balloon Catheter in Coronary In-stent Restenosis

Evaluation of the Efficacy and Safety of a Paclitaxel Eluting PTCA Balloon Catheter in Coronary In-stent Restenosis: a Randomized, Open-label, Positive Parallel Controlled, Multicenter Clinical Trial

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 212 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Over the past two decades, stents implantation has developed as a standard treatment for coronary stenosis lesions. However, int-stent restenosis (ISR) was one of the main factors affecting the long-term efficacy of coronary artery interventional therapy, with the incidence of ISR after percutaneous coronary intervention ranging from 5% to 35%. At present, there are three main means for ISR: (1) simple balloon dilation; 2) intravascular radiotherapy; and (3) drug elution stent. But the results are still not ideal. Drug coated balloon (DCB) is a new method that may be used to treat ISR in recent years. In the PEPCAD II study, when dealing with ISR, the paclitaxel eluting balloon (PEB) SeQuent® Please significantly reduced the major adverse cardiovascular events (MACEs) compared to the paclitaxel eluting stent (PES) TAXUS Liberte. In ISR-I and ISR-II trial, it was found that compared with uncoated PTCA balloons, PEB could significantly inhibit endothelial hyperplasia and significantly reduce MACEs treating ISR. The purpose of this study was to assess the efficacy and safety of a Chinese-developed PEB in treatment of coronary ISR compared to SeQuent® Please PEB.

Conditions

• Coronary In-stent Restenosis

Interventions

Type	Name	Description
DEVICE	Paclitaxel eluting PTCA balloon	Treatment of coronary in-stent re-stenosis with paclitaxel eluting PTCA balloon
DEVICE	SeQuent® Please paclitaxel eluting balloon	Treatment of coronary in-stent re-stenosis with SeQuent® Please paclitaxel eluting balloon

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-01-31
• Completion: 2020-12-31
• First posted: 2019-12-30
• Last updated: 2019-12-30

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated device study