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

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

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

Sponsors & Collaborators

• West China Hospital

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Second Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• The Third Xiangya Hospital of Central South University

  collaborator OTHER

• Hebei Medical University Third Hospital

  collaborator OTHER

• TEDA International Cardiovascular Hospital

  collaborator OTHER

• Tianjin People's Hospital

  collaborator OTHER

• The Second Hospital of Shandong University

  collaborator OTHER

• Hainan People's Hospital

  collaborator OTHER

• The First Affiliated Hospital of Xiamen University

  collaborator OTHER

• Shanghai Chest Hospital

  collaborator OTHER

• Renmin Hospital of Wuhan University

  collaborator OTHER

• Taizhou Hospital

  collaborator OTHER

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Principal Investigators

• Jian-an Wang, MD, PhD · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-01

Primary Completion

2020-01-31

Completion

2020-12-31

FDA Device

Yes

Countries

• China

Study Locations