GLASS Classification and CLTI

The Relationship Between the Global Limb Anatomic Staging System (GLASS) and Short Term Outcomes of Endovascular Management of Infrainguinal Lesions in Patients With Chronic Limb Threatening Ischemia (CLTI)"

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities

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 Type: Observational
• Enrollment (Anticipated): 36

Contacts and Locations

• Study Contact: Name: Haitham Ali Hassan, MD; Phone Number: 01006770588; Email: Haithamvascular@gmail.com
• Study Contact Backup: Name: Ayman Elsayed Hassaballah, MD; Phone Number: 0106647688; Email: aymanhasaballa@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Faculty of Medicine, Assiut University
    • Contact: Haitham Ali Hassan, MD; Phone Number: 01006770588; Email: Haithamvascular@gmail.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Probability Sample

Study Population

Patients attending the Vascular Surgery Clinics in Assiut University Hospitals with infra inguinal CLTI will be recruited to participate in the study. Based on high quality angiography, patients presented with CLTI will be assigned into 3 stages according to GLASS

Description

Inclusion Criteria:

• Patients with infrainguinal CLTI

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Imitate technical failure	Failure of passage of wire or Recoil of vessels during angioplasty	1 year
Limb based patency at 1 year	Patent vessels after endovascular management	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amputation free survival at 1 year	Limb preserved after endovascular intervention	1 year
Mortality Rate at 1 year	Death after endovascular intervention	1 year
Amputation rate at 1 year	Amputation after endovascular intervention	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Conte MS, Bradbury AW, Kolh P, White JV, Dick F, Fitridge R, Mills JL, Ricco JB, Suresh KR, Murad MH, Aboyans V, Aksoy M, Alexandrescu VA, Armstrong D, Azuma N, Belch J, Bergoeing M, Bjorck M, Chakfe N, Cheng S, Dawson J, Debus ES, Dueck A, Duval S, Eckstein HH, Ferraresi R, Gambhir R, Gargiulo M, Geraghty P, Goode S, Gray B, Guo W, Gupta PC, Hinchliffe R, Jetty P, Komori K, Lavery L, Liang W, Lookstein R, Menard M, Misra S, Miyata T, Moneta G, Munoa Prado JA, Munoz A, Paolini JE, Patel M, Pomposelli F, Powell R, Robless P, Rogers L, Schanzer A, Schneider P, Taylor S, De Ceniga MV, Veller M, Vermassen F, Wang J, Wang S; GVG Writing Group for the Joint Guidelines of the Society for Vascular Surgery (SVS), European Society for Vascular Surgery (ESVS), and World Federation of Vascular Societies (WFVS). Global Vascular Guidelines on the Management of Chronic Limb-Threatening Ischemia. Eur J Vasc Endovasc Surg. 2019 Jul;58(1S):S1-S109.e33. doi: 10.1016/j.ejvs.2019.05.006. Epub 2019 Jun 8. Erratum In: Eur J Vasc Endovasc Surg. 2020 Mar;59(3):492-493. Eur J Vasc Endovasc Surg. 2020 Jul;60(1):158-159.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2022
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: December 13, 2021
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: GLASS

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