DKutting Balloon Versus Chocolate Balloon to Treat Femoral and Popliteal Artery Stenosis

NCT05608655 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2024-02-20

No results posted yet for this study

Summary

A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of DKutting Balloon Versus Chocolate Balloon in the Treatment of Femoral and Popliteal Artery Stenosis

Conditions

  • Femoral Artery Stenosis
  • Popliteal Artery Stenosis

Interventions

DEVICE

DKutting LL balloon

After pre-dilation balloon is used (if any), DKutting LL balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment

DEVICE

Chocolate balloon

After pre-dilation balloon is used (if any), Chocolate balloon is used as final dilatation balloon before Stent implantation or Drug Coated Balloon deployment

Sponsors & Collaborators

  • DK Medical Technology (Suzhou) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Weiguo Fu, Dr. · Shanghai Zhongshan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-27
Primary Completion
2024-01-10
Completion
2024-02-04

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 NCT05608655 on ClinicalTrials.gov