Clinical trial NCT05209672: GLASS Classification and CLTI
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)"
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 36
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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)

Eligibility criteria: Inclusion Criteria:

* Patients with infrainguinal CLTI

Exclusion Criteria:

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

Primary outcomes:
measure: Imitate technical failure
timeFrame: 1 year
measure: Limb based patency at 1 year
timeFrame: 1 year
Secondary outcomes:
measure: Amputation free survival at 1 year
timeFrame: 1 year
measure: Mortality Rate at 1 year
timeFrame: 1 year
measure: Amputation rate at 1 year
timeFrame: 1 year
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of medicine, Assiut University
Study officials:
References:
citation: 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.