Clinical Study of Focal Implant Used for Lower Extremity Post-angioplasty Dissection
PINTO
A Prospective, Multicenter, Randomized Controlled Trail Using Spot Stenting to Treat Lower Extremity Post-angioplasty Dissection
1 other identifier
interventional
224
1 country
12
Brief Summary
This is a prospective, multicenter, randomized controlled trail using spot stenting to treat lower extremity post-angioplasty dissection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2022
Typical duration for not_applicable
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2022
CompletedFirst Posted
Study publicly available on registry
September 30, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2025
CompletedSeptember 30, 2022
September 1, 2022
1.3 years
August 15, 2022
September 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
primary patency rate at 12 months after operation
12 months
Secondary Outcomes (10)
success rate of the device
Intraoperation
success rate of the technique
post operation
rate of CD-TLR
6 months,12 months
ABI
post operation, 6 months,12 months
Rutherford classification
post operation, 6 months,12 months
- +5 more secondary outcomes
Study Arms (2)
ZENFLEX ® Pinto
EXPERIMENTALsubjects using the spot stent(ZENFLEX ® Pinto) system
Everflex
ACTIVE COMPARATORsubjects using the bare stent(Everflex) system
Interventions
the spot stent(ZENFLEX ® Pinto) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
the bare stent( Everflex) system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
Eligibility Criteria
You may qualify if:
- Age 18 to 80 years,male or female
- Lower extremity atherosclerotic occlusive disease
- 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)
- Subjects are able to understand the purpose of the study, demonstrate full compliance with the procedure and follow-up and sign informed consent
You may not qualify if:
- The target lesion has been stented or previously treated with bypass surgery
- Acute thrombosis of the target vessel requires thrombolysis or thrombectomy, or has undergone local or systemic thrombolysis within 48 hours
- Cutting balloon, thrombectomy, plaque resection, brachytherapy, and laser therapy were planned
- 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
- The target lesion was too calcified to undergo PTA or the guide wire could not pass anterograde through the target lesion
- Planned amputation on the target limb
- Severe allergy to anticoagulant drugs, antiplatelet drugs, contrast media and Nitinol
- Uncontrollable infections
- Women who are pregnant or breastfeeding, or who plan to become pregnant during the duration of the trial
- Participating in clinical trials of any other drug or medical device and not yet out of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoqiang Li
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2022
First Posted
September 30, 2022
Study Start
November 1, 2022
Primary Completion
February 1, 2024
Study Completion
February 1, 2025
Last Updated
September 30, 2022
Record last verified: 2022-09