Safety and Efficacy Study of FemFlow Drug-Eluting Peripheral Balloon Catheter

NCT03683459 | Unknown DMC

• 1 other identifier: DEB-01
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 18

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.

Conditions

Femoral Artery Stenosis; Femoral Artery Occlusion; Popliteal Arterial Stenosis; Popliteal Artery Occlusion

Keywords

FemFlow; Drug-eluting peripheral balloon catheter

Outcome Measures

Primary Outcomes (1)

• 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%.

  Postoperative 30 ± 7days

Secondary Outcomes (7)

• Target vascular cavity loss rate.

  Postoperative 180 ± 28days

• Rutherford Classification.

  Postoperative 30 ± 7days

• Ankle/brachial index (ABI)

  Postoperative 30 ± 7days

• Revascularization rate of target lesions

  Postoperative 30 ± 7days

• Revascularization rate of target vessels

  Postoperative 30 ± 7days

Study Arms (1)

interventional arm

EXPERIMENTAL

Participants will be treated with FemFlow Drug-Eluting Peripheral Balloon Catheter.

Device: FemFlow Drug-Eluting Peripheral Balloon Catheter

Interventions

FemFlow Drug-Eluting Peripheral Balloon Catheter DEVICE

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.

interventional arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Patients aged greater than 18 years old and less than 85 years old, regardless of gender；
• \. Patients with peripheral femoral or popliteal artery stenosis (greater than or equal to 70%) or occlusive disease;
• \. Rutherford classification graded 2-5；
• \. 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.

You may not qualify if:

• \. Patient with arteritis;
• \. Any acute thrombosis of target vessels requires thrombolysis or thrombectomy, or accepted local or systemic thrombolysis within 48 hours；
• \. Any cerebrovascular accidents within 3 months；
• \. Any unstable coronary heart disease or myocardial infarction within 3 months；
• \. Any important organ failure；
• \. Any known hypersensitivity to heparin, aspirin, clopidogrel, paclitaxel, paclitaxel compounds and contrast agents;
• \. Cannot accept antiplatelet and/or anticoagulation therapy；
• \. Patients with hemorrhagic physical diseases；
• \. Alanine transaminase (ALT) or Aspartate transaminase (AST) were five times higher than the normal upper limit；
• \. Serum creatinine \> 2mg/dl (177umol/L)；
• \. Pregnant or lactating woman；
• \. In the absence of intervention, the three lumens of tibialis anterior, tibialis posterior and peroneal artery stenosis or occlusion degree were all \>50%；
• \. iliac artery stenosis \>50%, or lumen stenosis \>50% after treatment (Limited to non-drug-eluting balloon or stent treatment only)；
• \. 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)；
• \. Severe calcification at target lesions and should not be treated with balloon dilatation therapy;

Sponsors & Collaborators

• Lifetech Scientific (Shenzhen) Co., Ltd.: lead

Study Sites (18)

Peking University People's Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Zhongshan Hospital Xiamen University

Xiamen, Fujian, China

NOT YET RECRUITING

The First People's Hospital of Foshan

Foshan, Guangdong, China

NOT YET RECRUITING

Zhongshang People's Hospital

Zhongshan, Guangdong, China

RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

NOT YET RECRUITING

Hainan General Hospital

Haikou, Hainan, China

RECRUITING

The Central Hospital of Wuhan

Wuhan, Hebei, China

NOT YET RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410008, China

RECRUITING

Xiangya Hospital Central South University

Changsha, Hunan, China

NOT YET RECRUITING

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

NOT YET RECRUITING

Shandong Provincial Hospital

Jinan, Shandong, China

NOT YET RECRUITING

Yantai YuHuangDing Hospital

Yantai, Shandong, China

NOT YET RECRUITING

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

NOT YET RECRUITING

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, China

NOT YET RECRUITING

Tianjing Medical University General Hospital

Tianjin, Tianjin Municipality, 300000, China

RECRUITING

Study Officials

• Guowei Fu

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Xia

CONTACT

+86 13760184511; xiaying@lifetechmed.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 25, 2018
• Study Start: July 18, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 5, 2020

Record last verified: 2020-02

Locations

CN (18)