A Trail of Drug-coated Balloon Treating Below The Knee Arterial Diseases

Last updated: June 10, 2022
Sponsor: Zhejiang Zylox Medical Device Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Peripheral Arterial Occlusive Disease

Peripheral Arterial Disease (Pad)

Claudication

Treatment

N/A

Clinical Study ID

NCT05415995
V1.1/2021-12-25
  • Ages 18-85
  • All Genders

Study Summary

This is a prospective, multicenter, randomized controlled trail using drug-coated balloon to treat below the knee arterial stenosis or occlusion.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18-85 years;
  • ≥70% diameter stenosis or occlusion in the target below-the-knee lesion;
  • Rutherford Category 3-6;
  • Subjects are willing to sign informed consent;

Exclusion

Exclusion Criteria:

  • Planned major limb amputation within 30 days after the procedure;
  • In-stent stenosis in the target lesion;
  • Severely calcified target lesions;
  • Creatinine>2.5mg/dL;
  • History of allergies to anesthetics, contrast agents;
  • Subjects who have participated in any other drug or medical device clinicalinvestigations and haven't reach the primary endpoint;
  • Other circumstances judged by researchers that are not suitable for enrollment.

Study Design

Total Participants: 202
Study Start date:
March 01, 2022
Estimated Completion Date:
December 31, 2024

Study Description

This trail is conducted in several centers all around China. 202 subjects with below the knee arterial stenosis or occlusion will be recruited and randomized, this trail compares the efficacy and safety of Drug-coated Balloon (Zylox-Tonbridge) with a similar balloon catheter producted by Acotec. The subjects will be followed up when discharged /in 30 days/ 6 months.

Connect with a study center

  • The second hospital of Anhui Medical university

    Hefei, Anhui
    China

    Site Not Available

  • Zhongshan Hospital Xiamen University

    Xiamen, Fujian
    China

    Site Not Available

  • Hebei General Hospital

    Shijiazhuang, Hebei
    China

    Site Not Available

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei
    China

    Site Not Available

  • HeNan Province People's Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • The First Affiliated Hospital Of Zhengzhou University

    Zhengzhou, Henan
    China

    Site Not Available

  • The central hospital of Wuhan

    Wuhan, Hubei
    China

    Site Not Available

  • Nanjing Drum Tower Hospital, the affiliated hospital of Nanjing University medical school

    Nanjing, Jiangsu
    China

    Site Not Available

  • The First Affiliated Hospital Of Dalian Medical University

    Dalian, Liaoning
    China

    Site Not Available

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning
    China

    Site Not Available

  • The affiliated Hospital of QingDao University

    Qingdao, Shandong
    China

    Site Not Available

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi
    China

    Site Not Available

  • The affiliated hospital of southwest medical university

    Luzhou, Sichuan
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin
    China

    Site Not Available

  • Affiliated HangZhou First People's Hospital, Zhejiang University School of medicine

    Hangzhou, Zhejiang
    China

    Site Not Available

  • Huamei hospital, University of Chinese academy of sciences

    Ningbo, Zhejiang
    China

    Site Not Available

  • China-Japan Friendship Hospital

    Beijing,
    China

    Site Not Available

  • Peking University First Hospital

    Beijing,
    China

    Site Not Available

  • Changhai Hospital

    Shanghai,
    China

    Active - Recruiting

  • Shanghai Ninth People's Hostpital, Shanghai JiaoTong University School of Medicine

    Shanghai,
    China

    Site Not Available

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