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Validating GLASS Score in Predicting Acute Limb Events in CLTI Patients

NCT06186544 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-01-02

No results posted yet for this study

Summary

Ischemia is a severe medical condition that occurs when the blood and oxygen supply to a specific part of the body is significantly reduced or completely absent, it can affect any body part, often the legs. It is typically caused by the narrowing or blockage of an artery and can result in severe pain, tissue gangrene, and the potential loss of a limb (Amputation). This condition requires medical intervention and will not improve on its own.

To diagnose leg ischemia, the doctor will conduct a thorough vascular clinical examination. Depending on the findings, further imaging tests such as duplex ultrasound, magnetic resonance arteriography (MRA), or computed tomography (CT) may be conducted. In some cases, an arteriogram may be necessary which is an x-ray of the arteries while the dye is injected into the blood vessels.

Following the diagnosis, the best management course is recommended by a multidisciplinary team (MDT), considering each patient's disease pattern and overall health. Treatment options include performing a key-hole procedure, called an endovascular procedure (EVT) within the artery, where the vascular surgeon will be using a balloon to widen the artery, and/or a wire-reinforced stent which remains inside the artery serving as a scaffolding to keep it open.

The primary aim of the PROMOTE GLASS study is to investigate if the Global Anatomical Staging System (GLASS) score, which is a summation of points given according to the disease pattern as seen on assessment images (Duplex Ultrasound, MRA, and CT scans) can accurately tell if the treatment using catheters and stents inside blood vessels will work well for people with ischemia in their legs. The researchers also want to see if the GLASS score can predict how well patients with ischemia will heal and if they will need further treatments in the long term after having treatment with catheters and stents inside their blood vessels.

A prospective, observational study will be delivered by Cardiff and Vale University Health Board (CAVUHB). The vascular team will prospectively collect data over a 12-month period. This will be in patients undergoing elective and/or emergency primary EVT procedure, with follow-up 4-6 weeks after the procedure and at 12 months.

Conditions

  • Chronic Limb-Threatening Ischemia

Sponsors & Collaborators

  • The European Vascular Research Collaborative (EVRC)

    collaborator UNKNOWN

  • Cardiff and Vale University Health Board

    lead OTHER_GOV

Principal Investigators

  • Lewis Meecham, FRCS · Cardiff and Vale University Health Board

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06186544 on ClinicalTrials.gov