Validating GLASS Score in Predicting Acute Limb Events in CLTI Patients

NCT06186544 | Unknown

• 2 other identifiers: 8682323934
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

CLTI; Chronic Limb Threatening Ischemia; Revascularization; MALE; MLLA; Limb based patency; Global Anatomical Staging system (GLASS); Angioplasty; Lower limb bypass

Outcome Measures

Primary Outcomes (3)

• Rate of Immediate Technical Success i.e. achievement of straight in-line flow to the foot as judged from the completion angiography

  Immediate technical success (ITS): The successful completion of endovascular therapy procedures without any major complications. Specifically, it is the successful achievement of the intended treatment goals, such as revascularization, stent deployment, or atherectomy. A procedure is considered to have achieved ITS when the desired therapeutic objectives are accomplished and the patient's vascular anatomy is adequately restored, without the need for additional intervention or conversion to open surgery.

  Day 0

• Rate of The immediate technical failure (ITF)

  Immediate technical failure (ITF): ITF is defined as the inability to successfully perform the desired endovascular intervention due to technical limitations. It encompasses scenarios such as inadequate vessel access, equipment malfunction, or procedural complications that prevent the completion of the intended procedure.

  Day 0

• Rate of LBP (as judged by the main surgeon based on symptoms and imaging up to 12 months)

  Limb based patency (LBP): limb-based patency (LBP) is defined as continued patency throughout the length of a defined target artery pathway (TAP) from the groin to the ankle. The TAP consists of the femoropopliteal (FP) segment, and a primary infrapopliteal (IP) runoff artery selected by the treating physician to achieve in-line flow to the foot or wound. LBP combines freedom from reintervention, occlusion, and severe stenosis of the TAP, along with freedom from hemodynamic failure (a significant decrease in ankle or toe pressures) in the presence of recurrent or unresolved CLTI symptoms.

  Day 1 and up to 12 months

Secondary Outcomes (4)

• Rate of MALE (as judged by the main surgeon based on symptoms and imaging up to 12 months)

  Day 1 and up to 12 months

• Rate of MLLA (as judged by the main surgeon based on symptoms and imaging up to 12 months)

  Day 1 and up to 12 months

• Overall survival (in months)

  Day 1 and up to 12 months

• Timings of any adverse clinical event (MALE, MLLA, Mortality)

  Day 1 and up to 12 months

Eligibility Criteria

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

Study Population

The study participants will consist of adult vascular patients diagnosed with chronic limb threatening ischemia (CLTI) who are scheduled to undergo endovascular intervention according to the standard care pathway. These participants will be selected from vascular surgery MDT and will represent a diverse range of demographics and clinical characteristics. Participants will be included based on specific eligibility criteria, such as age, severity of CLTI, previous interventions in the limb of interest and willingness to participate in the study. Throughout the study, participants will be followed longitudinally, with their GLASS scores recorded at presentation and major acute limb events monitored over 12 months.

You may qualify if:

• Patients with peripheral vascular disease (PVD) under investigation for CLTI
• Age 18 years or older

You may not qualify if:

• Patient with traumatic or iatrogenic lesions leading to CLTI.
• Acute Limb Ischemia (symptoms for \<2 weeks)
• Patients who have undergone open/endovascular revascularization of the same limb within the last 12 months
• Patients who present with inflow disease (Common iliac artery (CIA), External Iliac Artery (EIA), and Common Femoral artery (CFA) disease) not intended for treatment during the same admission or prior to recruitment.
• Palliative revascularization (for pain in end of life)
• Patient with expected problems of maintaining a 1-year follow-up (e.g., no fixed address)
• Patients with previously implanted devices (stents) within the affected segment

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead
• The European Vascular Research Collaborative (EVRC): collaborator

Study Sites (1)

Southeast Wales Vascular Network-Cardiff and Vale University Health Board

Cardiff, Wales, United Kingdom

Location

Related Publications (1)

• Darwish M, D'Oria M, Croo A, Melo RG, Meecham L; European Vascular Research Collaborative (EVRC). Prospective Multi-Center Longitudinal Study to Validate Accuracy of the Global Anatomic Staging System (GLASS) Score in Predicting Major Acute Limb Events in Patients With Chronic Limb Threatening Ischemia Undergoing Endovascular Intervention: The PROMOTE-GLASS Study Protocol. Vasc Endovascular Surg. 2025 Jan;59(1):29-38. doi: 10.1177/15385744241276690. Epub 2024 Sep 3.

  PMID: 39226237 DERIVED

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

Study Officials

• Lewis Meecham, FRCS

  Cardiff and Vale University Health Board

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maram Darwish, MD

CONTACT

+447841582039; maram.darwish@wales.nhs.uk

Rachel Norman

CONTACT

+442921846126; rachel.norman2@wales.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 2, 2024
• Study Start: January 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)