Back to resultsSafety and Efficacy Study of FemFlow Drug-Eluting Peripheral Balloon Catheter
Primary Purpose
Femoral Artery Stenosis, Femoral Artery Occlusion, Popliteal Arterial Stenosis
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
FemFlow Drug-Eluting Peripheral Balloon Catheter
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Artery Stenosis focused on measuring FemFlow, Drug-eluting peripheral balloon catheter
Eligibility Criteria
Inclusion Criteria:
1. Patients aged greater than 18 years old and less than 85 years old, regardless of gender；
2. Patients with peripheral femoral or popliteal artery stenosis (greater than or equal to 70%) or occlusive disease;
3. Rutherford classification graded 2-5；
4. The subject or its legal representative can understand the purpose of the study, show sufficient compliance with the test protocol, and sign the informed consent.
Exclusion Criteria:
1. Patient with arteritis;
2. Any acute thrombosis of target vessels requires thrombolysis or thrombectomy, or accepted local or systemic thrombolysis within 48 hours；
3. Any cerebrovascular accidents within 3 months；
4. Any unstable coronary heart disease or myocardial infarction within 3 months；
5. Any important organ failure；
6. Any known hypersensitivity to heparin, aspirin, clopidogrel, paclitaxel, paclitaxel compounds and contrast agents;
7. Cannot accept antiplatelet and/or anticoagulation therapy；
8. Patients with hemorrhagic physical diseases；
9. Alanine transaminase (ALT) or Aspartate transaminase (AST) were five times higher than the normal upper limit；
10. Serum creatinine > 2mg/dl (177umol/L)；
11. Pregnant or lactating woman；
12. In the absence of intervention, the three lumens of tibialis anterior, tibialis posterior and peroneal artery stenosis or occlusion degree were all >50%；
13. iliac artery stenosis >50%, or lumen stenosis >50% after treatment (Limited to non-drug-eluting balloon or stent treatment only)；
14. The guide wire cannot pass through target lesions (Passing through target lesions refers to the head of the guidewire arrive beyond the lesion in the absence of interlayer or perforation)；
15. Severe calcification at target lesions and should not be treated with balloon dilatation therapy;
16. Pre-dilation or anticipated severe vascular dissections after dilation;
17. Residual stricture of >50% or severe current-limiting dissection after pre-dilation is not suitable for simple balloon dilatation catheter treatment;
18. The total length of target lesions is >200mm, or the reference diameter of the target vessel was >7mm or <3mm;
19. Life expectancy is less than one year;
20. Participated in clinical trials of other drugs or instruments at the same time;
21. Other conditions not suitable for inclusion judged by researchers.
Sites / Locations
- Peking University People's Hospital
- Zhongshan Hospital Xiamen University
- The First People's Hospital of Foshan
- Zhongshang People's HospitalRecruiting
- The First Affiliated Hospital of Guangxi Medical University
- Hainan General HospitalRecruiting
- The Central Hospital of Wuhan
- The Second Xiangya Hospital of Central South UniversityRecruiting
- Xiangya Hospital Central South University
- The First Affiliated Hospital of University of South China
- Shandong Provincial Hospital
- Yantai YuHuangDing Hospital
- Zhongshan Hospital Fudan UniversityRecruiting
- Shanghai Changzheng Hospital
- Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
- Shanghai Sixth People's Hospital
- Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
- Tianjing Medical University General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
interventional arm
Arm Description
Participants will be treated with FemFlow Drug-Eluting Peripheral Balloon Catheter.
Outcomes
Primary Outcome Measures
Patency rate of the first phase
Target vessel patency is defined as all target lesion lumen stenosis of the target vessel ≤50%. Doppler ultrasonography showed that the peak systolic velocity ratio (PSVR) was ≤ 2.4, which could be considered as the target lesion stenosis ≤50%.
Secondary Outcome Measures
Target vascular cavity loss rate.
Target vascular cavity loss rate (LLL) is defined as the value of the minimum diameter reduction in the segment of target lesions after surgery. Evaluation was performed by lower limb artery digital subtraction angiography (DSA) examination.
Rutherford Classification.
Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.
Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
Ankle/brachial index (ABI)
The ankle/brachial index (ABI) is defined as the systolic pressure ratio of the tibialis posterior artery or tibialis anterior artery of the affected limb to the ipsilateral brachial artery when the subject is lying flat.
Revascularization rate of target lesions
Target lesion revascularization was defined as finding target lesion embolism or restenosis (stenosis in diameter of >50%) during follow-up, and additional intervention was required according to clinical symptoms.
Revascularization rate of target vessels
Target lesion revascularization was defined as finding target vessels embolism or restenosis (stenosis in diameter of >50%) during follow-up, and additional intervention was required according to clinical symptoms.
Operating success rate
Successful operation is defined as in the course of operation, the peripheral balloon catheter can reach the location of the disease and successfully expand, fail to rupture the balloon, and successfully withdraw.
Success rate of surgery
The success of surgery is defined as the residual stenosis rate ≤30% during the operation.
Full Information
NCT ID
NCT03683459
First Posted
September 20, 2018
Last Updated
February 3, 2020
Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03683459
Brief Title
Safety and Efficacy Study of FemFlow Drug-Eluting Peripheral Balloon Catheter
Official Title
Safety and Efficacy Study of FemFlow Drug-Eluting Peripheral Balloon Catheter for Lesions With Femoral-popliteal Artery Stenosis or Occlusion: a Prospective, Multi-centre, Objective Performance Criteria Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 18, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A prospective, multi-centre, objective performance criteria clinical trial to evaluate the safety and efficacy of FemFlow Drug-Eluting Peripheral Balloon Catheter manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for lesions with femoropopliteal artery stenosis or occlusion.
Detailed Description
This study is a prospective, multi-centre, single-group target value clinical study. Taking the patency rate at 12 months after operation as the primary evaluation index and taking target vascular cavity loss rate at 6 months postoperatively, Rutherford Classification at 12 months postoperatively, the ankle/brachial index (ABI), revascularization rate of target lesions, revascularization rate of target vessels, operating success rate and success rate of surgery as the secondary evaluation indexes to evaluate the efficacy of FemFlow Drug-Eluting Peripheral Balloon Catheter manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for lesions with femoropopliteal artery stenosis or occlusion. Taking the incidence of major adverse events (MAE), adverse events (AE) and instrument defects occurred through the entire trail as the evaluation indexes to evaluate the safety of FemFlow Drug-Eluting Peripheral Balloon Catheter manufactured by Lifetech Scientific (Shenzhen) Company for lesions with femoropopliteal artery stenosis or occlusion. According to statistical hypothesis and sample size calculation, the sample size of this clinical trial was 208 cases. All subjects were followed up 1 month, 6 months and 12 months after treatment with a FemFlow Drug-Eluting Peripheral Balloon Catheter, and data on efficacy and safety were collected. All relevant clinical data are managed and analyzed by the professional data management centre and the statistical centre. End-point events of clinical trials are determined by a specially established third party.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Artery Stenosis, Femoral Artery Occlusion, Popliteal Arterial Stenosis, Popliteal Artery Occlusion
Keywords
FemFlow, Drug-eluting peripheral balloon catheter
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
208 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
interventional arm
Arm Type
Experimental
Arm Description
Participants will be treated with FemFlow Drug-Eluting Peripheral Balloon Catheter.
Intervention Type
Device
Intervention Name(s)
FemFlow Drug-Eluting Peripheral Balloon Catheter
Intervention Description
Medical devices will be applied to the enrolled subjects. The arterial pathway was established, followed by lower limb arteriography, and the auxiliary equipment was selected according to the stenosis of the subject's target lesions, followed by pre-dilation. Patients with residual stenosis ≤70% after pre-dilation and suitable for simple balloon dilation catheter treatment can be enrolled. Select the appropriate size of the experimental drug balloon for expansion, then radiography was used to observe the expansion effect, if necessary, multiple expansion can be conducted, and finally withdraw the instrument and suture the puncture point.
Primary Outcome Measure Information:
Title
Patency rate of the first phase
Description
Target vessel patency is defined as all target lesion lumen stenosis of the target vessel ≤50%. Doppler ultrasonography showed that the peak systolic velocity ratio (PSVR) was ≤ 2.4, which could be considered as the target lesion stenosis ≤50%.
Time Frame
Postoperative 30 ± 7days
Secondary Outcome Measure Information:
Title
Target vascular cavity loss rate.
Description
Target vascular cavity loss rate (LLL) is defined as the value of the minimum diameter reduction in the segment of target lesions after surgery. Evaluation was performed by lower limb artery digital subtraction angiography (DSA) examination.
Time Frame
Postoperative 180 ± 28days
Title
Rutherford Classification.
Description
Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.
Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene
Time Frame
Postoperative 30 ± 7days
Title
Ankle/brachial index (ABI)
Description
The ankle/brachial index (ABI) is defined as the systolic pressure ratio of the tibialis posterior artery or tibialis anterior artery of the affected limb to the ipsilateral brachial artery when the subject is lying flat.
Time Frame
Postoperative 30 ± 7days
Title
Revascularization rate of target lesions
Description
Target lesion revascularization was defined as finding target lesion embolism or restenosis (stenosis in diameter of >50%) during follow-up, and additional intervention was required according to clinical symptoms.
Time Frame
Postoperative 30 ± 7days
Title
Revascularization rate of target vessels
Description
Target lesion revascularization was defined as finding target vessels embolism or restenosis (stenosis in diameter of >50%) during follow-up, and additional intervention was required according to clinical symptoms.
Time Frame
Postoperative 30 ± 7days
Title
Operating success rate
Description
Successful operation is defined as in the course of operation, the peripheral balloon catheter can reach the location of the disease and successfully expand, fail to rupture the balloon, and successfully withdraw.
Time Frame
Intraoperative
Title
Success rate of surgery
Description
The success of surgery is defined as the residual stenosis rate ≤30% during the operation.
Time Frame
Intraoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Patients aged greater than 18 years old and less than 85 years old, regardless of gender；
2. Patients with peripheral femoral or popliteal artery stenosis (greater than or equal to 70%) or occlusive disease;
3. Rutherford classification graded 2-5；
4. The subject or its legal representative can understand the purpose of the study, show sufficient compliance with the test protocol, and sign the informed consent.
Exclusion Criteria:
1. Patient with arteritis;
2. Any acute thrombosis of target vessels requires thrombolysis or thrombectomy, or accepted local or systemic thrombolysis within 48 hours；
3. Any cerebrovascular accidents within 3 months；
4. Any unstable coronary heart disease or myocardial infarction within 3 months；
5. Any important organ failure；
6. Any known hypersensitivity to heparin, aspirin, clopidogrel, paclitaxel, paclitaxel compounds and contrast agents;
7. Cannot accept antiplatelet and/or anticoagulation therapy；
8. Patients with hemorrhagic physical diseases；
9. Alanine transaminase (ALT) or Aspartate transaminase (AST) were five times higher than the normal upper limit；
10. Serum creatinine > 2mg/dl (177umol/L)；
11. Pregnant or lactating woman；
12. In the absence of intervention, the three lumens of tibialis anterior, tibialis posterior and peroneal artery stenosis or occlusion degree were all >50%；
13. iliac artery stenosis >50%, or lumen stenosis >50% after treatment (Limited to non-drug-eluting balloon or stent treatment only)；
14. The guide wire cannot pass through target lesions (Passing through target lesions refers to the head of the guidewire arrive beyond the lesion in the absence of interlayer or perforation)；
15. Severe calcification at target lesions and should not be treated with balloon dilatation therapy;
16. Pre-dilation or anticipated severe vascular dissections after dilation;
17. Residual stricture of >50% or severe current-limiting dissection after pre-dilation is not suitable for simple balloon dilatation catheter treatment;
18. The total length of target lesions is >200mm, or the reference diameter of the target vessel was >7mm or <3mm;
19. Life expectancy is less than one year;
20. Participated in clinical trials of other drugs or instruments at the same time;
21. Other conditions not suitable for inclusion judged by researchers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Xia
Phone
+86 13760184511
Email
xiaying@lifetechmed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guowei Fu
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaoming Zhang
Facility Name
Zhongshan Hospital Xiamen University
City
Xiamen
State/Province
Fujian
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojin Huang
Facility Name
The First People's Hospital of Foshan
City
Foshan
State/Province
Guangdong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Canhua Luo
Facility Name
Zhongshang People's Hospital
City
Zhongshan
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhang Miao
Facility Name
The First Affiliated Hospital of Guangxi Medical University
City
Nanning
State/Province
Guangxi
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao Qin
Facility Name
Hainan General Hospital
City
Haikou
State/Province
Hainan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhanxiang Xiao
Facility Name
The Central Hospital of Wuhan
City
Wuhan
State/Province
Hebei
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao He
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Name
Xiangya Hospital Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianhua Huang
Facility Name
The First Affiliated Hospital of University of South China
City
Hengyang
State/Province
Hunan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaoguang Feng
Facility Name
Shandong Provincial Hospital
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xing Jin
Facility Name
Yantai YuHuangDing Hospital
City
Yantai
State/Province
Shandong
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mu Yang
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guowei Fu, Professor
Facility Name
Shanghai Changzheng Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lefeng Qu
Facility Name
Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinwu Lu
Facility Name
Shanghai Sixth People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Zhao
Facility Name
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunshui He
Facility Name
Tianjing Medical University General Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangchen Dai
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy Study of FemFlow Drug-Eluting Peripheral Balloon Catheter
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