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GLASS Classification and CLTI

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ClinicalTrials.gov Identifier: NCT05209672
Recruitment Status : Not yet recruiting
First Posted : January 26, 2022
Last Update Posted : January 26, 2022
Sponsor:
Information provided by (Responsible Party):
Abdelrahman Ahmed Shawki Roshdi, Assiut University

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
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)

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Study Type : Observational
Estimated 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)"
Estimated Study Start Date : March 2022
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : March 2023



Primary Outcome Measures :
  1. Imitate technical failure [ Time Frame: 1 year ]
    Failure of passage of wire or Recoil of vessels during angioplasty

  2. Limb based patency at 1 year [ Time Frame: 1 year ]
    Patent vessels after endovascular management


Secondary Outcome Measures :
  1. Amputation free survival at 1 year [ Time Frame: 1 year ]
    Limb preserved after endovascular intervention

  2. Mortality Rate at 1 year [ Time Frame: 1 year ]
    Death after endovascular intervention

  3. Amputation rate at 1 year [ Time Frame: 1 year ]
    Amputation after endovascular intervention



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • Patients with infrainguinal CLTI

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05209672


Contacts
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Contact: Haitham Ali Hassan, MD 01006770588 Haithamvascular@gmail.com
Contact: Ayman Elsayed Hassaballah, MD 0106647688 aymanhasaballa@yahoo.com

Locations
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Egypt
Faculty of medicine, Assiut University
Assiut, Egypt
Contact: Haitham Ali Hassan, MD    01006770588    Haithamvascular@gmail.com   
Sponsors and Collaborators
Assiut University
Publications:
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Responsible Party: Abdelrahman Ahmed Shawki Roshdi, Responsible investigator, Assiut University
ClinicalTrials.gov Identifier: NCT05209672    
Other Study ID Numbers: GLASS
First Posted: January 26, 2022    Key Record Dates
Last Update Posted: January 26, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes