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Assess the Efficacy and Safety of RESTORE Paclitaxel Eluting Balloon Versus RESOLUTE Zotarolimus Eluting Stent for the Treatment of Small Coronary Vessel Disease

NCT02946307 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2019-07-29

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of RESTORE Paclitaxel eluting balloon in the treatment of Chinese patients with coronary heart disease and small vessel lesions in comparison with RESOLUTE Zotarolimus eluting stent.

Conditions

  • Coronary Stenosis

Interventions

DEVICE

Restore DEB（dimeter>2.00 mm）

DEVICE

Resolute DES

DEVICE

Restore DEB（dimeter:2.00 mm）

Sponsors & Collaborators

  • R&G Pharma Studies Co.,Ltd.

    collaborator INDUSTRY

  • ZhuHai Cardionovum Medical Device Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Runlin Gao, Master · Chinese Academy of Medical Sciences, Fuwai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-12-31
Completion
2019-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02946307 on ClinicalTrials.gov