Clinical trial NCT05498740: Post-marketing Study in Femoral Popliteal Artery of Drug Coated Balloon Used for Treatment of Lower Limb Ischemia
Official title: Post-marketing Study in Femoral Popliteal Artery of Drug Coated Ballon Used for Treatment of Lower Limb Ischemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Arterial Disease (PAD)
Lead sponsor: Zhejiang Zylox Medical Device Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-08-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Drug-coated Balloon catheters in the treatment of the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA).


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years old and ≤85 years old
2. Rutherford clinical category classification：2-5
3. Significant stenosis (≥50%) or occlusions of lesion(s) located in the superficial femoral artery an /or the popliteal artery
4. At least one patent native outflow artery to the ankle free from significant lesion as confirmed by angiography
5. Subject has provided written informed consent prior to participation , understands the purpose of this trail and agrees to comply with all protocol-specified examinations and follow-up appointments.

Exclusion Criteria:

1. Aneurysms near target lesions or popliteal aneurysms.
2. The guide wire cannot pass smoothly through the target lesion.
3. Known allergy to contrast agents, heparin or paclitaxel.
4. Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints or may enroll in other studies after enrollment in this clinical trial.
5. Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently lactating.
6. Other comorbidities, which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up.

Primary outcomes:
measure: rate of device success
timeFrame: intraoperative
measure: rate of procedural success
timeFrame: intraoperative
measure: rate of technical success
timeFrame: intraoperative
measure: rate of primary patency of target lesion
timeFrame: 12 months
measure: rate of primary patency of target lesion
timeFrame: 24 months
measure: rate of Clinically-driven TLR
timeFrame: 12 months
measure: rate of Clinically-driven TLR
timeFrame: 24 months
measure: rate of TLR
timeFrame: 1 month
measure: rate of TLR
timeFrame: 12 months
measure: rate of TLR
timeFrame: 24 months
measure: rate of Clinically-driven TVR
timeFrame: 12 months
measure: rate of Clinically-driven TVR
timeFrame: 24 months
measure: rate of TVR
timeFrame: 1 month
measure: rate of TVR
timeFrame: 12 months
measure: rate of TVR
timeFrame: 24 months
measure: change in Rutherford clinical category (target limb)
timeFrame: 12 months
measure: change in Rutherford clinical category (target limb)
timeFrame: 24 months
measure: change in ankle brachial index(ABI)
timeFrame: 12 months
measure: change in ankle brachial index(ABI)
timeFrame: 24 months
measure: rate of SAE
timeFrame: 12 months
measure: rate of SAE
timeFrame: 24 months
measure: rate of All-cause mortality
timeFrame: 1 month
measure: rate of All-cause mortality
timeFrame: 12 months
measure: rate of All-cause mortality
timeFrame: 24 months
measure: rate of Major amputation
timeFrame: 1 month
measure: rate of Major amputation
timeFrame: 12 months
measure: rate of Major amputation
timeFrame: 24 months
measure: rate of target lesion thrombosis
timeFrame: 12 months
measure: rate of target lesion thrombosis
timeFrame: 24 months
measure: Rate of adverse events
timeFrame: intraoperative
measure: Rate of adverse events
timeFrame: 1 month
measure: Rate of adverse events
timeFrame: 12 months
measure: Rate of adverse events
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xuanwu hospital
city: Chengde
country: China
facility: Affiliated Hospital of Chengde Medical College
city: Chengdu
country: China
facility: The Third People's Hospital of Chengdu
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
city: Dalian
country: China
facility: The Second Affiliated Hospital of Dalian Medical University
city: Guangzhou
country: China
facility: Guangzhou Huaqiao hospital
city: Guangzhou
country: China
facility: Hospital of Traditional Chinese Medicine affiliated to Guangzhou Medical University
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
city: Ha'erbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
city: Lanzhou
country: China
facility: First Hospital of Lanzhou University
city: Ningbo
country: China
facility: Ningbo huamei hospital
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
city: Rui'an
country: China
facility: Ruian People's Hospital
city: Shanghai
country: China
facility: Shanghai Ninth People'S Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital
city: Shenyang
country: China
facility: Northern Theatre General Hospital
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Tianjin
country: China
facility: Tianjin People's Hospital
city: Weifang
country: China
facility: Weifang People's Hospital
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University
city: Wenzhou
country: China
facility: The Second Affiliated Hospital of Wenzhou Medical University
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi 'an Jiaotong University School of Medicine
city: Xinjiang
country: China
facility: People's Hospital of Xinjiang Uygur Autonomous Region
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Weiguo Fu
role: PRINCIPAL_INVESTIGATOR
References: