The Role of Glass Stage Compared to WIFI Stage in Predicting Limb Salvage

NCT06209866 | Unknown

• 1 other identifier: Glass Stage and WIFI Stage
• Study Type: observational
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

compare between GLASS and WIFI Staging in predicting limb salvage in patients with chronic limb threatening ischemia ( CLTI) undergoing endovascular revascularization.

Conditions

Chronic Limb-Threatening Ischemia

Outcome Measures

Primary Outcomes (6)

• Technical Success

  in - line arterial flow to the foot without any flow limiting dissection or residual stenosis \> 30% on completion intraoperative arteriography

  Baseline

• Time to complete healing

  Time to complete healing of the wound after revascularization, Debridement or minor amputation

  Baseline

• Limb Salvage

  freedom from major amputation above the foot level

  Baseline

• Primary Patency

  uninterrupted vessel patency with no procedure performed on the treated limb.

  Baseline

• Assisted Primary Patency

  the percentage of failing but still patent vessel undergoing elective intervention, included patients required revision of the revascularization before vessel occlusion occurs as prophylactic interventions to maintain patency.

  Baseline

• Secondary Patency

  an occluded artery that required intervention to restore patency.

  Baseline

Interventions

PTA DEVICE

Percutaneous Trans lumenal Angioplasty

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients at vascular surgery department of Assiut university

You may qualify if:

• Patients with CLTI who will undergo endovascular revascularization at our department:
• Rutherford stage 4 ( rest pain) ,stage 5 (ischemic ulceration not exceeding ulcer of the digits of the foot) , stage 6 ( severe ischemic ulcers or frank gangrene)

You may not qualify if:

• Rutherford stage 1,2,3 Aortoiliac level of occlusion Unsalvageable limb Patients with contraindications to contrast media Non Atherosclerotic lschemia as • Acute ischemia
• Post Traumatic Ischemia
• Chronic ischemia caused by connective tissue diseases or vasculitis

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Nehler MR, Duval S, Diao L, Annex BH, Hiatt WR, Rogers K, Zakharyan A, Hirsch AT. Epidemiology of peripheral arterial disease and critical limb ischemia in an insured national population. J Vasc Surg. 2014 Sep;60(3):686-95.e2. doi: 10.1016/j.jvs.2014.03.290. Epub 2014 May 10.

  PMID: 24820900 BACKGROUND

• Ananthakumar Murugavel, Ajay Savlania, Arunanshu Behera,Mandeep Kang, Comparison of GLASS Stage with WIfI Clinical Staging for Predicting Limb Salvage in Peripheral Arterial Disease.j.jvs.2023.01.104

  BACKGROUND

• 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.

  PMID: 31182334 BACKGROUND

• Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12.

  PMID: 24126108 BACKGROUND

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Central Study Contacts

Mohamed Ahmed Mohamed, Resident

CONTACT

01028524010; mohamedbashandy20@gmail.com

Mohamed Salah Abdelkareem, Lecturer

CONTACT

01067568289; dms@aun.edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mohamed.15235432@med.aun.edu.eg

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: January 18, 2024
• Study Start: February 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: January 23, 2024

Record last verified: 2024-01