Clinical trial NCT05562076: Clinical Study of Focal Implant Used for Lower Extremity Post-angioplasty Dissection
Official title: A Prospective, Multicenter, Randomized Controlled Trail Using Spot Stenting to Treat Lower Extremity Post-angioplasty Dissection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Artery Disease
Lead sponsor: Zhejiang Zylox Medical Device Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-09-30
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Age 18 to 80 years,male or female
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:

1. The target lesion has been stented or previously treated with bypass surgery
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

Primary outcomes:
measure: primary patency rate at 12 months after operation
timeFrame: 12 months
Secondary outcomes:
measure: success rate of the device
timeFrame: Intraoperation
measure: success rate of the technique
timeFrame: post operation
measure: rate of CD-TLR
timeFrame: 6 months,12 months
measure: ABI
timeFrame: post operation, 6 months,12 months
measure: Rutherford classification
timeFrame: post operation, 6 months,12 months
measure: the incidence of major adverse events
timeFrame: 30 days, 6 months,12 months
measure: the rate of target limb major amputation
timeFrame: 30 days, 6 months,12 months
measure: the incidence of adverse events
timeFrame: Intraoperation, post operation, 30 days, 6 months,12 months
measure: the incidence of SAE
timeFrame: Intraoperation, post operation, 30 days, 6 months,12 months
measure: the rate of device defect
timeFrame: Intraoperation, 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
city: Changzhou
country: China
facility: Changzhou First People's Hospital
city: Changzhou
country: China
facility: Changzhou Second People's Hospital
city: Ha'erbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Qingdao
country: China
facility: Affiliated Hospital of Qingdao University
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Yangzhou
country: China
facility: North Jiangsu People's Hospital
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: Xiaoqiang Li
role: PRINCIPAL_INVESTIGATOR
References: