Predictive Value of the Global Limb Anatomic Staging System (GLASS) in Patients With Critical Limb-threatening Ischemia

NCT05999669 | Not Yet Recruiting DMC

• 1 other identifier: GLASS-EVT
• Study Type: observational
• Target: 2,000
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Global Vascular Guideline on chronic limb threatening ischemia (CLTI) proposes the Global Limb Anatomic Staging System (GLASS), a new angiographic scoring system to quantify the anatomic severity of infrainguinal disease in CLTI patients. However, GLASS validation still needs to be completed, and the infrapopliteal (IP) target artery pathway (TAP) was easily influenced by the procedures. Thus the IP target artery could be selected either as the least diseased artery based on angiography or prospectively based on the angiosome concept. So the investigators aim to evaluate its correlation with clinical outcomes after revascularization.

Conditions

Peripheral Arterial Disease

Keywords

global limb anatomic staging system; infrainguinal Lesion; critical limb-threatening ischemia

Outcome Measures

Primary Outcomes (1)

• Rate of freedom from major adverse events (MAEs)

  Major adverse events (MAEs) is defined as index limb amputation above the ankle, clinical-driven target lesion revascularization (CD-TLR), or all-cause death

  12-month

Secondary Outcomes (5)

• Rate of acute procedure success

  72-hour after procedure

• Rate of freedom from clinical-driven target lesion revascularization (CD-TLR)

  24-month

• Rate of freedom from major adverse events (MAEs)

  24-month

• Primary sustained clinical improvement assessed by Rutherford classification

  24-month

• Change of quality of life assessed by Vasc quality of life scale

  24-month

Interventions

GLASS staging OTHER

use the Global Limb Anatomic Staging System (GLASS) to evaluate its correlation with clinical outcomes after revascularization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with infrainguinal lesions suffering from critical limb-threatening ischemia

You may qualify if:

• Clinical diagnosis of chronic limb-threatening ischemia (CLTI)
• Undergo endovascular therapy for infrainguinal lesions

You may not qualify if:

• Pregnant women or female patients with potential childbearing
• Patients who have acute limb thromboembolism or require thrombectomy during the procedure
• Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion)
• Patients with known allergy to contrast media

Sponsors & Collaborators

• RenJi Hospital: lead
• Xuanwu Hospital, Beijing: collaborator
• Second Affiliated Hospital of Soochow University: collaborator
• First Affiliated Hospital of Zhejiang University: collaborator
• First People's Hospital of Hangzhou: collaborator
• Qingdao Haici Hospital: collaborator
• Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology: collaborator
• Fudan University: collaborator
• Huashan Hospital: collaborator
• Xiamen Cardiovascular Hospital, Xiamen University: collaborator
• Chengdu University of Traditional Chinese Medicine: collaborator

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Meng Ye, M.D.

  Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ni Qihong, M.D.

CONTACT

+8615801900772; niqihong1989@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2023
• First Posted: August 21, 2023
• Study Start: August 20, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 21, 2023

Record last verified: 2023-08