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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05999669
• Other study ID #: GLASS-EVT
• Status: Not yet recruiting
• Start date: August 20, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: August 2023
• Source: RenJi Hospital
• Contact: Ni Qihong, M.D.
• Phone: +8615801900772
• Email: niqihong1989[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (11)

Lead Sponsor

Collaborator

RenJi Hospital

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Rate of freedom from clinical-driven target lesion revascularization (CD-TLR)	Patients without clinical-driven target lesion revascularization (CD-TLR)	24-month
Secondary	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
Secondary	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
Secondary	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