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
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
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