Clinical Study of Focal Implant Used for Lower Extremity Post-angioplasty Dissection

NCT05562076 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2022-09-30

No results posted yet for this study

Summary

This is a prospective, multicenter, randomized controlled trail using spot stenting to treat lower extremity post-angioplasty dissection.

Conditions

Interventions

DEVICE

the spot stent(ZENFLEX ® Pinto) system

the spot stent(ZENFLEX ® Pinto) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography(DSA)

DEVICE

the bare stent( Everflex) system

the bare stent( Everflex) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography(DSA)

Sponsors & Collaborators

  • Zhejiang Zylox Medical Device Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaoqiang Li · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2024-02-29
Completion
2025-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT05562076 on ClinicalTrials.gov