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NCT Number: NCT04710420

Prospective Multicenter Registry on the Endovascular Treatment in Critical Limb Threatening Ischemia With Below the Knee Lesions With Wound, Ischemia, and Foot Infection (WIFI) Assessment

This is a prospective multicenter clinical study that used WIFI grading scores at different periods to evaluate the therapeutic value of endovascular therapy and this grading system for Chronic limb-threatening ischemia.

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Key information

Conditions

Chronic Limb-Threatening Ischemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Chronic Disease Disease Attributes Endovascular Therapy Ischemia Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Arterial Disease Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital

Beijing, Beijing Municipality, 100053, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients > 18 years of age;
  • patients with Chronic limb-threatening ischemia (CLTI);
  • patients with below-the-knee lesions undergoing endovascular treatment;
  • target limbs with certain WIfI stage;
  • patients voluntary and capable of follow-up;
  • informed consent.

Definition of CLTI:

A diagnosis of CLTI requires objectively documented atherosclerotic PAD in association with ischemic rest pain or tissue loss (ulceration or gangrene).

Exclusion criteria

  • Contraindication for antiplatelet , anticoagulant or thrombolytic agent;
  • Contrast agent allergy;
  • Dysfunctional protein C, protein S, antithrombin Ⅲ(AT Ⅲ) or refusal of blood transfusion;
  • Complications affecting surgical safety;
  • Major amputation was adopted to the target extremity;
  • The existence of aneurysm in the target vessels;
  • The existence of perforation, dissection or any other injury requiring intervention in the target vessels.

Treatment and study plan

Endovascular therapy

Device

Endovascular treatment for critical limb threatening Ischemia

Primary outcomes

  1. Freedom from major amputation

    Time frame: 12 months

    Major amputation was defined as any amputation above-the-ankle of the target limb.

Secondary outcomes

  1. WIfI stages

    Time frame: 12 months

    Before follow-up and during each follow-up, the Society for Vascular Surgery wound, ischemia, and foot Infection (WIfI) were evaluated classification system.

  2. Amputation-free survival

    Time frame: 12 months

    Survival without target limb major amputation.

  3. Freedom from all-cause death

    Time frame: 12 months

    Freedom from all-cause death.

  4. Freedom from clinically driven target limb reintervention

    Time frame: 12 months

    Clinically driven target limb reintervention was defined as any reintervention of ipsilateral infrapopliteal arteries for recurrent clinical symptoms.

  5. Freedom from major adverse event

    Time frame: 12 months

    Major adverse event was a composite of major amputation, all-cause death, and clinically driven target limb reintervention.

  6. Quality of life

    Time frame: 12 months

    The Vascular Quality of Life (VascuQol) questionnaire was used to assess QOL score.

  7. Primary sustained clinical improvement

    Time frame: 12 months

    A decrease of at least 1 Rutherford grade without any reintervention.

  8. Hospitalization time

    Time frame: 12 months

    The length of hospital stay was evaluated

  9. Hospitalization expenses

    Time frame: 12 months

    Hospitalization costs for patients were evaluated

  10. Adverse event rates

    Time frame: 1 week

    Adverse event rates includes surgically related arterial dissection, perforation, rupture, embolism, acute thrombosis, pseudoaneurysm and hematoma formation

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Collaborators

  • Chengdu University of Traditional Chinese Medicine
  • First Affiliated Hospital of Zhejiang University
  • Fudan University
  • Huashan Hospital
  • Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Qingdao Haici Hospital
  • RenJi Hospital
  • Second Affiliated Hospital of Soochow University
  • Zhejiang University

Registry information

Official study title

Prospective Multicenter Registry on the Endovascular Treatment in Critical Limb Threatening Ischemia With Below the Knee Lesions With WIFI Assessment

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 14, 2021
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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