GLASS Classification and CLTI

• Conditions: Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities

• Registration Number: NCT05209672
• Lead Sponsor: Assiut University

Brief Summary

Critical limb threatening ischemia "CLTI 'is not a separate local disease but also it is a part of generalized vascular disorder. A clinical syndrome that can be presented by many symptoms and signs as rest pain, gangrene and chronic ulceration more than 2 weeks (1).

Detailed Description

The Global Vascular guidelines 'GVG "proposes a new Global Anatomic Staging System (GLASS), GLASS incorporates two novel and important concepts, the target arterial path (TAP) and estimated limb-based patency (LBP). Based on appropriate angiographic imaging, the TAP is defined by the treating surgeon or internationalist as the optimal arterial pathway to restore in-line (pulsatile) flow to the ankle and foot. LBP allows more direct comparison of anatomic outcomes across revascularization strategies in CLTI. The complexity of disease traversed by the TAP is integrated in the GLASS. Femoropopliteal (FP) and infrapopliteal (IP) arterial segments are individually graded on a scale of 0 to 4.(2)(3) Using a consensus based matrix, these segmental grades are combined into three overall GLASS (I-III) stages for the limb, reflecting the complexity of the disease with a proposed likelihood of immediate technical failure ' ITF " and 1 year "LBP " after endovascular intervention of " TAP ' (1)

Study Timeline

• Study First Submitted: 2021-12-13
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-24
• Last Update Submitted: 2022-01-24
• Study First Posted: 2022-01-26
• Last Update Posted: 2022-01-26
• Study Start: 2022-03
• Primary Completion: 2023-02
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Patients with infrainguinal CLTI

Exclusion Criteria

• Patients with concomitant Aorto-iliac lesions
• Acute ischemia patients
• Post Traumatic ischemia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Imitate technical failure	1 year	Failure of passage of wire or Recoil of vessels during angioplasty
Limb based patency at 1 year	1 year	Patent vessels after endovascular management

Secondary Outcome Measures

Name	Time	Method
Amputation free survival at 1 year	1 year	Limb preserved after endovascular intervention
Mortality Rate at 1 year	1 year	Death after endovascular intervention
Amputation rate at 1 year	1 year	Amputation after endovascular intervention

Trial Locations

Locations (1)

Faculty of medicine, Assiut University; 🇪🇬 Assiut, Egypt