NCT05498740

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

24 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 4, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 12, 2022

Status Verified

August 1, 2022

Enrollment Period

7 months

First QC Date

July 22, 2022

Last Update Submit

August 11, 2022

Conditions

Peripheral Arterial Disease (PAD)

Outcome Measures

Primary Outcomes (33)

  • 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

    12 months

  • Rate of adverse events

    24 months

Study Arms (1)

drug eluting balloon catheter

EXPERIMENTAL

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

Device: Drug eluting Balloon

Interventions

Drug eluting BalloonDEVICE

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.

drug eluting balloon catheter

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Xuanwu hospital

Beijing, China

RECRUITING

Affiliated Hospital of Chengde Medical College

Chengde, China

RECRUITING

The Third People's Hospital of Chengdu

Chengdu, China

RECRUITING

The First Affiliated Hospital of Dalian Medical University

Dalian, China

RECRUITING

The Second Affiliated Hospital of Dalian Medical University

Dalian, China

RECRUITING

Guangzhou Huaqiao hospital

Guangzhou, China

RECRUITING

Hospital of Traditional Chinese Medicine affiliated to Guangzhou Medical University

Guangzhou, China

RECRUITING

The Third Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

RECRUITING

Hangzhou First People's Hospital

Hangzhou, China

RECRUITING

The First Affiliated Hospital of Harbin Medical University

Ha’erbin, China

RECRUITING

First Hospital of Lanzhou University

Lanzhou, China

RECRUITING

Ningbo huamei hospital

Ningbo, China

RECRUITING

Qingdao Municipal Hospital

Qingdao, China

RECRUITING

Ruian People's Hospital

Rui’an, China

RECRUITING

Shanghai Ninth People'S Hospital

Shanghai, China

RECRUITING

Zhongshan Hospital

Shanghai, China

RECRUITING

Northern Theatre General Hospital

Shenyang, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, China

RECRUITING

Tianjin People's Hospital

Tianjin, China

RECRUITING

Weifang People's Hospital

Weifang, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

RECRUITING

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

RECRUITING

The First Affiliated Hospital of Xi 'an Jiaotong University School of Medicine

Xi'an, China

RECRUITING

People's Hospital of Xinjiang Uygur Autonomous Region

Xinjiang, China

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Weiguo Fu

    Shanghai Zhongshan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Liang

CONTACT

13819565660jie.liang@zyloxmedical.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

July 22, 2022

First Posted

August 12, 2022

Study Start

May 4, 2022

Primary Completion

December 1, 2022

Study Completion

December 1, 2024

Last Updated

August 12, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(24)