Post-marketing Study in Femoral Popliteal Artery of Drug Coated Balloon Used for Treatment of Lower Limb Ischemia (UltraFuture I)

Post-marketing Study in Femoral Popliteal Artery of Drug Coated Ballon Used for Treatment of Lower Limb Ischemia

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).

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease (PAD)
• Intervention / Treatment: Device: Drug eluting Balloon

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Xuanwu Hospital
    • Contact: Yongquan Gu
  • Chengde, China
    • Recruiting
    • Affiliated Hospital of Chengde Medical College
    • Contact: Hong Zhang
  • Chengdu, China
    • Recruiting
    • The Third People's Hospital of Chengdu
    • Contact: Chi Cui
  • Dalian, China
    • Recruiting
    • The First Affiliated Hospital of Dalian Medical University
    • Contact: Ming Qi
  • Dalian, China
    • Recruiting
    • The Second Affiliated Hospital of Dalian Medical University
    • Contact: Lei Song
  • Guangzhou, China
    • Recruiting
    • Guangzhou Huaqiao hospital
    • Contact: Yan Zhang
  • Guangzhou, China
    • Recruiting
    • Hospital of Traditional Chinese Medicine affiliated to Guangzhou Medical University
    • Contact: Meng Du
  • Guangzhou, China
    • Recruiting
    • The Third Affiliated Hospital of Guangzhou Medical University
    • Contact: Chenyu Yang
  • Ha'erbin, China
    • Recruiting
    • The First Affiliated Hospital of Harbin Medical University
    • Contact: Bing Liu
  • Hangzhou, China
    • Recruiting
    • Hangzhou First People's Hospital
    • Contact: Xin Fang
  • Lanzhou, China
    • Recruiting
    • First Hospital of Lanzhou University
    • Contact: Xiaojun Shu
  • Ningbo, China
    • Recruiting
    • Ningbo huamei hospital
    • Contact: Dehai Lang
  • Qingdao, China
    • Recruiting
    • Qingdao Municipal Hospital
    • Contact: Dalin Li
  • Rui'an, China
    • Recruiting
    • Ruian People's Hospital
    • Contact: Changsheng Shi
  • Shanghai, China
    • Recruiting
    • Zhongshan Hospital
  • Shanghai, China
    • Recruiting
    • Shanghai ninth people's hospital
    • Contact: Minyi Yin
  • Shenyang, China
    • Recruiting
    • Northern Theatre General Hospital
    • Contact: Hong Jiang
  • Tianjin, China
    • Recruiting
    • Tianjin Medical University General Hospital
  • Tianjin, China
    • Recruiting
    • Tianjin People's Hospital
    • Contact: Li Su
  • Weifang, China
    • Recruiting
    • Weifang People's Hospital
    • Contact: Jiefeng Zhang
  • Wenzhou, China
    • Recruiting
    • The First Affiliated Hospital of Wenzhou Medical University
    • Contact: Jingyong Huang
  • Wenzhou, China
    • Recruiting
    • The Second Affiliated Hospital of Wenzhou Medical University
    • Contact: Xiangtao Zheng
  • Xi'an, China
    • Recruiting
    • The First Affiliated Hospital of Xi 'an Jiaotong University School of Medicine
    • Contact: Hongyan Tian
  • Xinjiang, China
    • Recruiting
    • People's Hospital of Xinjiang Uygur Autonomous Region
    • Contact: Sheng Guan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: drug eluting balloon catheter; use drug eluting balloon catheter to treat the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery	Device: Drug eluting Balloon; Drug eluting Balloon is a kind of the product that has been used for many years. By filling the micropores on the surface of the balloon with anti-proliferative drugs like immunosuppressive agents, the balloon is expanded and contacted with the lesion to rapidly release the drug to the local arterial wall.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of adverse events	12 months
rate of device success	intraoperative
rate of procedural success	intraoperative
rate of technical success	intraoperative
rate of primary patency of target lesion	12 months
rate of primary patency of target lesion	24 months
rate of Clinically-driven TLR	12 months
rate of Clinically-driven TLR	24 months
rate of TLR	1 month
rate of TLR	12 months
rate of TLR	24 months
rate of Clinically-driven TVR	12 months
rate of Clinically-driven TVR	24 months
rate of TVR	1 month
rate of TVR	12 months
rate of TVR	24 months
change in Rutherford clinical category (target limb)	12 months
change in Rutherford clinical category (target limb)	24 months
change in ankle brachial index(ABI)	12 months
change in ankle brachial index(ABI)	24 months
rate of SAE	12 months
rate of SAE	24 months
rate of All-cause mortality	1 month
rate of All-cause mortality	12 months
rate of All-cause mortality	24 months
rate of Major amputation	1 month
rate of Major amputation	12 months
rate of Major amputation	24 months
rate of target lesion thrombosis	12 months
rate of target lesion thrombosis	24 months
Rate of adverse events	intraoperative
Rate of adverse events	1 month
Rate of adverse events	24 months

Collaborators and Investigators

• Sponsor: Zhejiang Zylox Medical Device Co., Ltd.
• Investigators: Principal Investigator: Weiguo Fu, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: August 11, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Actual): August 12, 2022
• Last Update Submitted That Met QC Criteria: August 11, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: 04202106

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No