GLASS Classification and CLTI

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05209672

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

36 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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)"

Anticipated Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with infrainguinal CLTI

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of medicine, Assiut University	Assiut		Egypt

Sponsors and Collaborators

Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

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, Chakfé 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.

Responsible Party:

Abdelrahman Ahmed Shawki Roshdi, Responsible investigator, Assiut University

ClinicalTrials.gov Identifier:

NCT05209672

Other Study ID Numbers:

GLASS

First Posted:

Jan 26, 2022

Last Update Posted:

Jan 26, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ischemia

Study Results

No Results Posted as of Jan 26, 2022