Chronic Limb-Threatening IschemiaPROMOTEGLASSNCT06186544
Validating GLASS Score in Predicting Acute Limb Events in CLTI Patients
An observational study of Chronic Limb-Threatening Ischemia, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Limb-Threatening Ischemia
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2024to Jan 2026
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with peripheral vascular disease (PVD) under investigation for CLTI
- Age 18 years or older
- Able to consent to inclusion.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Southeast Wales Vascular Network-Cardiff and Vale University Health Board
Cardiff, Wales
Lewis Meecham, FRCS, +447772109824, lewis.meecham@wales.nhs.uk
Maram Darwish, MD, +447841582039, maram.darwish@wales.nhs.uk
About this study
Official title: Prospective Longitudinal Study To Validate Accuracy Of The Global Anatomical Staging System (GLASS) Score In Predicting Major Acute Limb Events In Patients With Chronic Limb Threatening Ischemia Undergoing Endovascular Intervention
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.
Read more
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.
Read the detailed description
The Global Vascular Guideline (GVG) is an expert consensus, representing every major vascular society, aiming to promote a standardized evidence-based approach to assessing and treating patients with Chronic Limb Threatening Ischemia (CLTI). In terms of revascularization, the GVG recommendations revolve around three independent variables: patient risk, limb severity, and anatomic complexity (PLAN). Each section is fundamental to providing successful treatment to the patient, much controversy remains on which patterns of anatomical disease should be treated with endovascular or open surgery. To that end, the GLobal Anatomic Staging System (GLASS) was developed and adopted by the GVG committee as an angiographic scoring system to quantify the extent of infra-inguinal disease and predict the likely success of treatment with endovascular techniques (EVT).
GLASS is intended to predict the immediate technical success (ITS) and the 1-year limb base patency (LBP) after the EVT of the target artery pathway (TAP) and therefore aid in decision making. Currently there is no other risk prediction score or risk prediction model that estimates the probability of having ITS, LBP, major adverse limb events (MALE), major lower limb amputation (MLLA) and overall survival (OS) in patients presenting with CLTI who undergo EVT.
The purpose of this longitudinal prospective study is to examine the validity and reliability of the GLASS score in predicting ITS, LBP, MALE, MLLA, and OS in patients with CLTI, eventually helping to identify those patients who are likely to benefit from EVT. This could help clinicians make more informed decisions about treatment options, potentially reducing the need for more invasive procedures and improving patient outcomes. Additionally, the GLASS score could be used as a tool for patient selection in future clinical trials evaluating endovascular interventions for CLTI.
This study will follow a prospective observational study design. The study will initially be conducted within the Southeast Wales Vascular Network at Cardiff and Vale University Health Board. However, the study protocol allows for the inclusion of other hospitals or vascular units to participate in a collaborative model or as primary investigator sites, subject to obtaining necessary ethics approval and sponsorship agreement. The decision to involve additional sites will be made following a thorough evaluation by the research and development (R\&D) committee. This approach will ensure compliance with ethical guidelines and regulatory requirements while also fostering potential collaboration and broadening the study's reach and generalizability.
Patients will be identified through routine clinic referrals and emergency presentations with CLTI; only patients who are referred for EVT will be recruited. Recruited patients will consent to access to their medical files and radiological data (duplex scans and angiography images) and a clinical follow-up up to one year. Standard care pathways are followed beyond this point. Outcome data will be collected from patients' medical files and interventional radiology reports immediately after the EVT and from vascular surgery clinic follow-up notes over a 12 months period. Symptom scores, admissions records, clinical and imaging data will be analysed at the end of follow-up to validate risk prediction. This will be supported by the European Vascular Research Collaborative (EVRC).
This study will be supervised by the Chief Investigator, Mr. Lewis Meecham (Consultant Vascular and Endovascular Surgeon) and sponsored by Cardiff and Vale University Health Board. An internal management group consisting of clinicians, researchers and managerial staff will be established to oversee and monitor the progress of the study. The management group will meet on a monthly basis to raise, discuss, and resolve any issues arising during the conduct of the study.
- 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
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
Major adverse limb events (MALE): MALE is defined as limb-related events including major amputations, acute limb ischemia requiring urgent revascularization, or repeat interventions due to disease progression or complications.
Measured: 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)
Major Lower Limb Amputation (MLLA): MLLA is defined as above ankle amputations of the leg i.e. either above knee amputation (Transfemoral amputation), below knee amputation (Transtibial amputation), or through knee amputation.
Measured: Day 1 and up to 12 months
Overall survival (in months)
Overall survival (OS): OS is defined as freedom from death up to 12 months from the treatment date due to any cause.
Measured: Day 1 and up to 12 months
Timings of any adverse clinical event (MALE, MLLA, Mortality)
If presented before the scheduled follow up
Measured: Day 1 and up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study startJan 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Limb-Threatening IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Collaborators
- The European Vascular Research Collaborative (EVRC)
- Responsible party
- Sponsor
- Investigators
- Lewis Meecham, FRCS, Principal investigator, Cardiff and Vale University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06186544
- Sponsor's protocol ID
- 8682
- Other IDs
- 323934
- Acronym
- PROMOTEGLASS
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study will take place in Cardiff and Vale UHB. All investigators and researchers must comply with the requirements of the General Data Protection Regulation (GDPR) Europe (EU) (2016/679) with regards to the collection, storage, processing, and disclosure of personal information. Data collected during the course of the study will be kept strictly confidential and accessed only by members of the study team. Data will be entered directly into the study database via a secure data capture and management software (CASTOR) that is GDPR compliant, access will be granted for the responsible surgeons only. Each case will be given a pseudo-anonymized number to avoid sharing of patient identifiable information. Study data will be archived in accordance with the Cardiff \& Vale UHB Archiving of Clinical Trial and Research Study Data Standard Operating Procedure. No personal identifiable data relating to patients will be retained beyond the end of the study.
Publications
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.
PubMed 39226237
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Longitudinal Study To Validate Accuracy Of The Global Anatomical Staging System (GLASS) Score In Predicting Major Acute Limb Events In Patients With Chronic Limb Threatening Ischemia Undergoing Endovascular Intervention
- ClinicalTrials.gov ID
- NCT06186544
- Acronym / sponsor ID
- PROMOTEGLASS / 8682
- Conditions
- Chronic Limb-Threatening Ischemia
- Keywords
- CLTI, Chronic Limb Threatening Ischemia, Revascularization, MALE, MLLA, Limb based patency, Global Anatomical Staging system (GLASS), Angioplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Collaborators
- The European Vascular Research Collaborative (EVRC)
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 2 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Global Vascular Guideline (GVG) is an expert consensus, representing every major vascular society, aiming to promote a standardized evidence-based approach to assessing and treating patients with Chronic Limb Threatening Ischemia (CLTI). In terms of revascularization, the GVG recommendations revolve around three independent variables: patient risk, limb severity, and anatomic complexity (PLAN). Each section is fundamental to providing successful treatment to the patient, much controversy remains on which patterns of anatomical disease should be treated with endovascular or open surgery. To that end, the GLobal Anatomic Staging System (GLASS) was developed and adopted by the GVG committee as an angiographic scoring system to quantify the extent of infra-inguinal disease and predict the likely success of treatment with endovascular techniques (EVT).
GLASS is intended to predict the immediate technical success (ITS) and the 1-year limb base patency (LBP) after the EVT of the target artery pathway (TAP) and therefore aid in decision making. Currently there is no other risk prediction score or risk prediction model that estimates the probability of having ITS, LBP, major adverse limb events (MALE), major lower limb amputation (MLLA) and overall survival (OS) in patients presenting with CLTI who undergo EVT.
The purpose of this longitudinal prospective study is to examine the validity and reliability of the GLASS score in predicting ITS, LBP, MALE, MLLA, and OS in patients with CLTI, eventually helping to identify those patients who are likely to benefit from EVT. This could help clinicians make more informed decisions about treatment options, potentially reducing the need for more invasive procedures and improving patient outcomes. Additionally, the GLASS score could be used as a tool for patient selection in future clinical trials evaluating endovascular interventions for CLTI.
This study will follow a prospective observational study design. The study will initially be conducted within the Southeast Wales Vascular Network at Cardiff and Vale University Health Board. However, the study protocol allows for the inclusion of other hospitals or vascular units to participate in a collaborative model or as primary investigator sites, subject to obtaining necessary ethics approval and sponsorship agreement. The decision to involve additional sites will be made following a thorough evaluation by the research and development (R\&D) committee. This approach will ensure compliance with ethical guidelines and regulatory requirements while also fostering potential collaboration and broadening the study's reach and generalizability.
Patients will be identified through routine clinic referrals and emergency presentations with CLTI; only patients who are referred for EVT will be recruited. Recruited patients will consent to access to their medical files and radiological data (duplex scans and angiography images) and a clinical follow-up up to one year. Standard care pathways are followed beyond this point. Outcome data will be collected from patients' medical files and interventional radiology reports immediately after the EVT and from vascular surgery clinic follow-up notes over a 12 months period. Symptom scores, admissions records, clinical and imaging data will be analysed at the end of follow-up to validate risk prediction. This will be supported by the European Vascular Research Collaborative (EVRC).
This study will be supervised by the Chief Investigator, Mr. Lewis Meecham (Consultant Vascular and Endovascular Surgeon) and sponsored by Cardiff and Vale University Health Board. An internal management group consisting of clinicians, researchers and managerial staff will be established to oversee and monitor the progress of the study. The management group will meet on a monthly basis to raise, discuss, and resolve any issues arising during the conduct of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Patients with peripheral vascular disease (PVD) under investigation for CLTI
- Age 18 years or older
- Able to consent to inclusion.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of Immediate Technical Success i.e. achievement of straight in-line flow to the foot as judged from the completion angiography
Time frame: Day 0
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.
Rate of The immediate technical failure (ITF)
Time frame: Day 0
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.
Rate of LBP (as judged by the main surgeon based on symptoms and imaging up to 12 months)
Time frame: Day 1 and 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.
4 secondary outcomes
Rate of MALE (as judged by the main surgeon based on symptoms and imaging up to 12 months)
Time frame: 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)
Time frame: Day 1 and up to 12 months
Overall survival (in months)
Time frame: Day 1 and up to 12 months
Timings of any adverse clinical event (MALE, MLLA, Mortality)
Time frame: Day 1 and up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Derived from this study: PubMed 39226237Darwish 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.
- Individual participant dataSharing planned: No. The study will take place in Cardiff and Vale UHB. All investigators and researchers must comply with the requirements of the General Data Protection Regulation (GDPR) Europe (EU) (2016/679) with regards to the collection, storage, processing, and disclosure of personal information. Data collected during the course of the study will be kept strictly confidential and accessed only by members of the study team. Data will be entered directly into the study database via a secure data capture and management software (CASTOR) that is GDPR compliant, access will be granted for the responsible surgeons only. Each case will be given a pseudo-anonymized number to avoid sharing of patient identifiable information. Study data will be archived in accordance with the Cardiff \& Vale UHB Archiving of Clinical Trial and Research Study Data Standard Operating Procedure. No personal identifiable data relating to patients will be retained beyond the end of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lewis Meecham, FRCS principal investigator
Cardiff and Vale University Health Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Limb-Threatening Ischemia, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maram Darwish, MD (+447841582039, maram.darwish@wales.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Immediate Technical Success i.e. achievement of straight in-line flow to the foot as judged from the completion angiography (time frame: Day 0). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06186544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.