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

Assessing the Predictive Value of the Global Limb Anatomic Staging System (GLASS) in EndoVascular Therapy (EVT) of Infrainguinal Lesions in Patients With Critical Limb-threatening Ischemia (CLTI): the GLASS-EVT Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Other: GLASS staging

Detailed Description

The Global Vascular Guideline on chronic limb threatening ischemia (CLTI) recommends using the Global Limb Anatomic Staging System (GLASS) to assess the severity of infrainguinal disease in CLTI patients. GLASS staging involves scoring the femoropopliteal (FP) and infrapopliteal (IP) segments separately. For IP segment scoring, the target artery path (TAP) is identified by the clinician based on either the least diseased or the recanalized IP path. However, this approach may lead to diverse GLASS staging results, especially for simple lesions below the knee. Additionally, the current version of GLASS does not account for multivessel IP revascularization, which may introduce subjective bias if a physician chooses different IP targets during multiple revascularization procedures.

In order to improve our understanding of the current staging system, the investigators will establish a prospective registry that collects data on conservative patients who have Chronic Limb-Threatening Ischemia (CLTI) and undergo endovascular therapy for infrainguinal lesions. To evaluate the stage of the lesions, the investigators will use two distinct IP scoring techniques. One approach will be based on the least disease IP path as identified by the pre-interventional angiogram, while the second technique will be based on the recanalized IP path preferred by the clinician. This scoring will be carried out by experienced physicians and the results will be recorded in an electronic database. Then the correlation between the major adverse limb events (such as clinical-driven target limb revascularization, major amputation, and all-cause death) with the patient's Wound, Ischemia, foot Infection (WIFI) classification, GLASS anatomic staging, calcification severity, and modified Society for Vascular Surgery (SVS) run-off score will be analyzed.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Ni Qihong, M.D.; Phone Number: +8615801900772; Email: niqihong1989@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with infrainguinal lesions suffering from critical limb-threatening ischemia

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of acute procedure success	Acute procedure success is defined as technique success ( the achievement of final residual diameter stenosis <30% for stent and <50% for angioplasty or atherectomy by angiography at the end of the procedure and without flow-limiting arterial dissection or hemodynamically significant trans-lesional pressure gradient <10 mm Hg for endovascular revascularization ) and freedom form MAEs within 72 hours of the index procedure.	72-hour after procedure
Rate of freedom from clinical-driven target lesion revascularization (CD-TLR)	Patients without clinical-driven target lesion revascularization (CD-TLR)	24-month
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	24-month
Primary sustained clinical improvement assessed by Rutherford classification	Primary sustained clinical improvement is defined as an upward shift on the Rutherford classification to a level of claudication without the need for repeated target lesion revascularization in surviving patients without the need for unplanned amputation.	24-month
Change of quality of life assessed by Vasc quality of life scale	Postoperative Vasc quality of life score minus preoperative Vasc quality of life score	24-month

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Collaborators: First People's Hospital of Hangzhou; Fudan University; Huashan Hospital; Chengdu University of Traditional Chinese Medicine; Xuanwu Hospital, Beijing; First Affiliated Hospital of Zhejiang University; Second Affiliated Hospital of Soochow University; Qingdao Haici Hospital; Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology; Xiamen Cardiovascular Hospital, Xiamen University
• Investigators: Principal Investigator: Meng Ye, M.D., Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University

Study record dates

Study Major Dates

• Study Start (Estimated): August 20, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 30, 2023
• First Submitted That Met QC Criteria: August 13, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 13, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: global limb anatomic staging system; infrainguinal Lesion; critical limb-threatening ischemia
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: GLASS-EVT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No