Clinical Study of Focal Implant Used for Lower Extremity Post-angioplasty Dissection
NCT ID: NCT05562076
Last Updated: 2022-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
224 participants
INTERVENTIONAL
2022-11-30
2025-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ZENFLEX ® Pinto
subjects using the spot stent(ZENFLEX ® Pinto) system
the spot stent(ZENFLEX ® Pinto) system
the spot stent(ZENFLEX ® Pinto) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
Everflex
subjects using the bare stent(Everflex) system
the bare stent( Everflex) system
the bare stent( Everflex) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
Interventions
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the spot stent(ZENFLEX ® Pinto) system
the spot stent(ZENFLEX ® Pinto) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
the bare stent( Everflex) system
the bare stent( Everflex) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
Eligibility Criteria
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Inclusion Criteria
2. Lower extremity atherosclerotic occlusive disease
3. After PTA, angiography showed less than 30% residual stenosis of the target lesion (based on visual estimation), and there is one or more dissection(Type A-F)
4. Subjects are able to understand the purpose of the study, demonstrate full compliance with the procedure and follow-up and sign informed consent
Exclusion Criteria
2. Acute thrombosis of the target vessel requires thrombolysis or thrombectomy, or has undergone local or systemic thrombolysis within 48 hours
3. Cutting balloon, thrombectomy, plaque resection, brachytherapy, and laser therapy were planned
4. More than 30% residual stenosis of the inflow artery (based on visual estimation) after treatment, or there is no outflow artery in the target limb
5. The target lesion was too calcified to undergo PTA or the guide wire could not pass anterograde through the target lesion
6. Planned amputation on the target limb
7. Severe allergy to anticoagulant drugs, antiplatelet drugs, contrast media and Nitinol
8. Uncontrollable infections
9. Women who are pregnant or breastfeeding, or who plan to become pregnant during the duration of the trial
10. Participating in clinical trials of any other drug or medical device and not yet out of the study
11. Other circumstances not suitable for inclusion as judged by the investigator
18 Years
80 Years
ALL
Yes
Sponsors
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Zhejiang Zylox Medical Device Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Xiaoqiang Li
Role: PRINCIPAL_INVESTIGATOR
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Locations
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Xuanwu Hospital, Capital Medical University
Beijing, , China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, , China
Changzhou First People's Hospital
Changzhou, , China
Changzhou Second People's Hospital
Changzhou, , China
The First Affiliated Hospital of Harbin Medical University
Ha’erbin, , China
Anhui Provincial Hospital
Hefei, , China
The Second Affiliated Hospital of Nanchang University
Nanchang, , China
Nanjing Drum Tower Hospital
Nanjing, , China
Affiliated Hospital of Qingdao University
Qingdao, , China
Shanghai Ninth People's Hospital
Shanghai, , China
Tianjin Medical University General Hospital
Tianjin, , China
North Jiangsu People's Hospital
Yangzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Lianrui Guo
Role: primary
Chaowen Yu
Role: primary
Yufeng Zhu
Role: primary
Yunfeng Zhu
Role: primary
Bing Liu
Role: primary
Weimin Zhou
Role: primary
Xiaoqiang Li
Role: primary
Mingjin Guo
Role: primary
Xinwu Lu
Role: primary
Xiangchen Dai
Role: primary
Zhaolei Chen
Role: primary
Other Identifiers
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72202207
Identifier Type: -
Identifier Source: org_study_id