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

Primary Purpose

Peripheral Arterial Disease (PAD)

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Drug eluting Balloon
Sponsored by
Zhejiang Zylox Medical Device Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease (PAD)

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Xuanwu hospitalRecruiting
  • Affiliated Hospital of Chengde Medical CollegeRecruiting
  • The Third People's Hospital of ChengduRecruiting
  • The First Affiliated Hospital of Dalian Medical UniversityRecruiting
  • The Second Affiliated Hospital of Dalian Medical UniversityRecruiting
  • Guangzhou Huaqiao hospitalRecruiting
  • Hospital of Traditional Chinese Medicine affiliated to Guangzhou Medical UniversityRecruiting
  • The Third Affiliated Hospital of Guangzhou Medical UniversityRecruiting
  • The First Affiliated Hospital of Harbin Medical UniversityRecruiting
  • Hangzhou First People's HospitalRecruiting
  • First Hospital of Lanzhou UniversityRecruiting
  • Ningbo huamei hospitalRecruiting
  • Qingdao Municipal HospitalRecruiting
  • Ruian People's HospitalRecruiting
  • Shanghai Ninth People'S HospitalRecruiting
  • Zhongshan HospitalRecruiting
  • Northern Theatre General HospitalRecruiting
  • Tianjin Medical University General HospitalRecruiting
  • Tianjin People's HospitalRecruiting
  • Weifang People's HospitalRecruiting
  • The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
  • The Second Affiliated Hospital of Wenzhou Medical UniversityRecruiting
  • The First Affiliated Hospital of Xi 'an Jiaotong University School of MedicineRecruiting
  • People's Hospital of Xinjiang Uygur Autonomous RegionRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

drug eluting balloon catheter

Arm Description

use drug eluting balloon catheter to treat the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery

Outcomes

Primary Outcome Measures

rate of device success
rate of procedural success
rate of technical success
rate of primary patency of target lesion
rate of primary patency of target lesion
rate of Clinically-driven TLR
rate of Clinically-driven TLR
rate of TLR
rate of TLR
rate of TLR
rate of Clinically-driven TVR
rate of Clinically-driven TVR
rate of TVR
rate of TVR
rate of TVR
change in Rutherford clinical category (target limb)
change in Rutherford clinical category (target limb)
change in ankle brachial index(ABI)
change in ankle brachial index(ABI)
rate of SAE
rate of SAE
rate of All-cause mortality
rate of All-cause mortality
rate of All-cause mortality
rate of Major amputation
rate of Major amputation
rate of Major amputation
rate of target lesion thrombosis
rate of target lesion thrombosis
Rate of adverse events
Rate of adverse events
Rate of adverse events
Rate of adverse events

Secondary Outcome Measures

Full Information

First Posted
July 22, 2022
Last Updated
August 11, 2022
Sponsor
Zhejiang Zylox Medical Device Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05498740
Brief Title
Post-marketing Study in Femoral Popliteal Artery of Drug Coated Balloon Used for Treatment of Lower Limb Ischemia
Acronym
UltraFuture I
Official Title
Post-marketing Study in Femoral Popliteal Artery of Drug Coated Ballon Used for Treatment of Lower Limb Ischemia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 4, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Zylox Medical Device Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease (PAD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
drug eluting balloon catheter
Arm Type
Experimental
Arm Description
use drug eluting balloon catheter to treat the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
Intervention Type
Device
Intervention Name(s)
Drug eluting Balloon
Intervention Description
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.
Primary Outcome Measure Information:
Title
rate of device success
Time Frame
intraoperative
Title
rate of procedural success
Time Frame
intraoperative
Title
rate of technical success
Time Frame
intraoperative
Title
rate of primary patency of target lesion
Time Frame
12 months
Title
rate of primary patency of target lesion
Time Frame
24 months
Title
rate of Clinically-driven TLR
Time Frame
12 months
Title
rate of Clinically-driven TLR
Time Frame
24 months
Title
rate of TLR
Time Frame
1 month
Title
rate of TLR
Time Frame
12 months
Title
rate of TLR
Time Frame
24 months
Title
rate of Clinically-driven TVR
Time Frame
12 months
Title
rate of Clinically-driven TVR
Time Frame
24 months
Title
rate of TVR
Time Frame
1 month
Title
rate of TVR
Time Frame
12 months
Title
rate of TVR
Time Frame
24 months
Title
change in Rutherford clinical category (target limb)
Time Frame
12 months
Title
change in Rutherford clinical category (target limb)
Time Frame
24 months
Title
change in ankle brachial index(ABI)
Time Frame
12 months
Title
change in ankle brachial index(ABI)
Time Frame
24 months
Title
rate of SAE
Time Frame
12 months
Title
rate of SAE
Time Frame
24 months
Title
rate of All-cause mortality
Time Frame
1 month
Title
rate of All-cause mortality
Time Frame
12 months
Title
rate of All-cause mortality
Time Frame
24 months
Title
rate of Major amputation
Time Frame
1 month
Title
rate of Major amputation
Time Frame
12 months
Title
rate of Major amputation
Time Frame
24 months
Title
rate of target lesion thrombosis
Time Frame
12 months
Title
rate of target lesion thrombosis
Time Frame
24 months
Title
Rate of adverse events
Time Frame
intraoperative
Title
Rate of adverse events
Time Frame
1 month
Title
Rate of adverse events
Time Frame
12 months
Title
Rate of adverse events
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥18 years old and ≤85 years old Rutherford clinical category classification：2-5 Significant stenosis (≥50%) or occlusions of lesion(s) located in the superficial femoral artery an /or the popliteal artery At least one patent native outflow artery to the ankle free from significant lesion as confirmed by angiography 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: Aneurysms near target lesions or popliteal aneurysms. The guide wire cannot pass smoothly through the target lesion. Known allergy to contrast agents, heparin or paclitaxel. 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. Pregnancy or female patient with child bearing potential not taking adequate contraceptives or currently lactating. Other comorbidities, which in the opinion of the investigator limit longevity or likelihood of compliance with protocol follow up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Liang
Phone
13819565660
Email
jie.liang@zyloxmedical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiguo Fu
Organizational Affiliation
Shanghai Zhongshan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xuanwu hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongquan Gu
Facility Name
Affiliated Hospital of Chengde Medical College
City
Chengde
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Zhang
Facility Name
The Third People's Hospital of Chengdu
City
Chengdu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chi Cui
Facility Name
The First Affiliated Hospital of Dalian Medical University
City
Dalian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Qi
Facility Name
The Second Affiliated Hospital of Dalian Medical University
City
Dalian
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lei Song
Facility Name
Guangzhou Huaqiao hospital
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Zhang
Facility Name
Hospital of Traditional Chinese Medicine affiliated to Guangzhou Medical University
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meng Du
Facility Name
The Third Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chenyu Yang
Facility Name
The First Affiliated Hospital of Harbin Medical University
City
Ha'erbin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Liu
Facility Name
Hangzhou First People's Hospital
City
Hangzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Fang
Facility Name
First Hospital of Lanzhou University
City
Lanzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaojun Shu
Facility Name
Ningbo huamei hospital
City
Ningbo
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dehai Lang
Facility Name
Qingdao Municipal Hospital
City
Qingdao
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dalin Li
Facility Name
Ruian People's Hospital
City
Rui'an
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Changsheng Shi
Facility Name
Shanghai Ninth People'S Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minyi Yin
Facility Name
Zhongshan Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiguo Fu
Facility Name
Northern Theatre General Hospital
City
Shenyang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hong Jiang
Facility Name
Tianjin Medical University General Hospital
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangchen Dai
Facility Name
Tianjin People's Hospital
City
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Su
Facility Name
Weifang People's Hospital
City
Weifang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiefeng Zhang
Facility Name
The First Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingyong Huang
Facility Name
The Second Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiangtao Zheng
Facility Name
The First Affiliated Hospital of Xi 'an Jiaotong University School of Medicine
City
Xi'an
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongyan Tian
Facility Name
People's Hospital of Xinjiang Uygur Autonomous Region
City
Xinjiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng Guan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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