Clinical Study of Focal Implant Used for Lower Extremity Post-angioplasty Dissection
- Conditions
- Peripheral Artery Disease
- Interventions
- Device: the spot stent(ZENFLEX ® Pinto) systemDevice: the bare stent( Everflex) system
- Registration Number
- NCT05562076
- Lead Sponsor
- Zhejiang Zylox Medical Device Co., Ltd.
- Brief Summary
This is a prospective, multicenter, randomized controlled trail using spot stenting to treat lower extremity post-angioplasty dissection.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 224
- 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
- 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
- Other circumstances not suitable for inclusion as judged by the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ZENFLEX ® Pinto the spot stent(ZENFLEX ® Pinto) system subjects using the spot stent(ZENFLEX ® Pinto) system Everflex the bare stent( Everflex) system subjects using the bare stent(Everflex) system
- Primary Outcome Measures
Name Time Method primary patency rate at 12 months after operation 12 months
- Secondary Outcome Measures
Name Time Method success rate of the device Intraoperation success rate of the technique post operation rate of CD-TLR 6 months,12 months the rate of target limb major amputation 30 days, 6 months,12 months the rate of device defect Intraoperation, 12 months ABI post operation, 6 months,12 months Rutherford classification post operation, 6 months,12 months the incidence of major adverse events 30 days, 6 months,12 months the incidence of SAE Intraoperation, post operation, 30 days, 6 months,12 months the incidence of adverse events Intraoperation, post operation, 30 days, 6 months,12 months
Trial Locations
- Locations (12)
Changzhou First People's Hospital
🇨🇳Changzhou, China
Changzhou Second People's Hospital
🇨🇳Changzhou, China
Xuanwu Hospital, Capital Medical University
🇨🇳Beijing, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, China
Anhui Provincial Hospital
🇨🇳Hefei, China
The First Affiliated Hospital of Harbin Medical University
🇨🇳Ha'erbin, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
Shanghai Ninth People's Hospital
🇨🇳Shanghai, China
Affiliated Hospital of Qingdao University
🇨🇳Qingdao, China
Tianjin Medical University General Hospital
🇨🇳Tianjin, China
North Jiangsu People's Hospital
🇨🇳Yangzhou, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, China