GLASS Classification and CLTI

NCT ID: NCT05209672

Last Updated: 2022-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2023-03-31

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)

Conditions

Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients with infrainguinal CLTI

Exclusion Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Abdelrahman Ahmed Shawki Roshdi

Responsible investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of medicine, Assiut University

Asyut, , Egypt

Countries

Egypt

Central Contacts

Haitham Ali Hassan, MD

Role: CONTACT

Haithamvascular@gmail.com

01006770588

Ayman Elsayed Hassaballah, MD

Role: CONTACT

aymanhasaballa@yahoo.com

0106647688

Facility Contacts

Haitham Ali Hassan, MD

Role: primary

Haithamvascular@gmail.com

01006770588

References

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.

Reference Type: BACKGROUND

PMID: 31182334 (View on PubMed)

Other Identifiers

GLASS

Identifier Type: -

Identifier Source: org_study_id