Peripheral Arterial DiseaseNCT05999669
Predictive Value of the Global Limb Anatomic Staging System (GLASS) in Patients With Critical Limb-threatening Ischemia
An observational study of Peripheral Arterial Disease, run by RenJi Hospital.
Trial summary
The Global Vascular Guideline on chronic limb threatening ischemia (CLTI) proposes the Global Limb Anatomic Staging System (GLASS), a new angiographic scoring system to quantify the anatomic severity of infrainguinal disease in CLTI patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- GLASS staging
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patients with infrainguinal lesions suffering from critical limb-threatening ischemia
Who may be able to join
- Clinical diagnosis of chronic limb-threatening ischemia (CLTI)
- Undergo endovascular therapy for infrainguinal lesions
Who cannot join
- Pregnant women or female patients with potential childbearing
- Patients who have acute limb thromboembolism or require thrombectomy during the procedure
- Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion)
- Patients with known allergy to contrast media
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Assessing the Predictive Value of the Global Limb Anatomic Staging System (GLASS) in EndoVascular Therapy (EVT) of Infrainguinal Lesions in Patients With Critical Limb-threatening Ischemia (CLTI): the GLASS-EVT Study
The Global Vascular Guideline on chronic limb threatening ischemia (CLTI) proposes the Global Limb Anatomic Staging System (GLASS), a new angiographic scoring system to quantify the anatomic severity of infrainguinal disease in CLTI patients. However, GLASS validation still needs to be completed, and the infrapopliteal (IP) target artery pathway (TAP) was easily influenced by the procedures. Thus the IP target artery could be selected either as the least diseased artery based on angiography or prospectively based on the angiosome concept. So the investigators aim to evaluate its correlation with clinical outcomes after revascularization.
Read the detailed description
The Global Vascular Guideline on chronic limb threatening ischemia (CLTI) recommends using the Global Limb Anatomic Staging System (GLASS) to assess the severity of infrainguinal disease in CLTI patients. GLASS staging involves scoring the femoropopliteal (FP) and infrapopliteal (IP) segments separately. For IP segment scoring, the target artery path (TAP) is identified by the clinician based on either the least diseased or the recanalized IP path. However, this approach may lead to diverse GLASS staging results, especially for simple lesions below the knee. Additionally, the current version of GLASS does not account for multivessel IP revascularization, which may introduce subjective bias if a physician chooses different IP targets during multiple revascularization procedures.
In order to improve our understanding of the current staging system, the investigators will establish a prospective registry that collects data on conservative patients who have Chronic Limb-Threatening Ischemia (CLTI) and undergo endovascular therapy for infrainguinal lesions. To evaluate the stage of the lesions, the investigators will use two distinct IP scoring techniques. One approach will be based on the least disease IP path as identified by the pre-interventional angiogram, while the second technique will be based on the recanalized IP path preferred by the clinician. This scoring will be carried out by experienced physicians and the results will be recorded in an electronic database. Then the correlation between the major adverse limb events (such as clinical-driven target limb revascularization, major amputation, and all-cause death) with the patient's Wound, Ischemia, foot Infection (WIFI) classification, GLASS anatomic staging, calcification severity, and modified Society for Vascular Surgery (SVS) run-off score will be analyzed.
- Conditions
- Peripheral Arterial Disease
- Being tested
- GLASS staging
- Keywords
- global limb anatomic staging system, infrainguinal Lesion, critical limb-threatening ischemia
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLASS stagingOther
use the Global Limb Anatomic Staging System (GLASS) to evaluate its correlation with clinical outcomes after revascularization
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of freedom from major adverse events (MAEs)
Major adverse events (MAEs) is defined as index limb amputation above the ankle, clinical-driven target lesion revascularization (CD-TLR), or all-cause death
Measured: 12-month
Secondary outcomes (5)
Rate of acute procedure success
Acute procedure success is defined as technique success ( the achievement of final residual diameter stenosis <30% for stent and <50% for angioplasty or atherectomy by angiography at the end of the procedure and without flow-limiting arterial dissection or hemodynamically significant trans-lesional pressure gradient <10 mm Hg for endovascular revascularization ) and freedom form MAEs within 72 hours of the index procedure.
Measured: 72-hour after procedure
Rate of freedom from clinical-driven target lesion revascularization (CD-TLR)
Patients without clinical-driven target lesion revascularization (CD-TLR)
Measured: 24-month
Rate of freedom from major adverse events (MAEs)
Major adverse events (MAEs) is defined as index limb amputation above the ankle, clinical-driven target lesion revascularization (CD-TLR), or all-cause death
Measured: 24-month
Primary sustained clinical improvement assessed by Rutherford classification
Primary sustained clinical improvement is defined as an upward shift on the Rutherford classification to a level of claudication without the need for repeated target lesion revascularization in surviving patients without the need for unplanned amputation.
Measured: 24-month
Change of quality of life assessed by Vasc quality of life scale
Postoperative Vasc quality of life score minus preoperative Vasc quality of life score
Measured: 24-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start20 Aug 2023 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Second Affiliated Hospital of Soochow University, First Affiliated Hospital of Zhejiang University, First People's Hospital of Hangzhou, Qingdao Haici Hospital, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Fudan University, Huashan Hospital, Xiamen Cardiovascular Hospital, Xiamen University, Chengdu University of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Meng Ye, M.D., Principal investigator, Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05999669
- Sponsor's protocol ID
- GLASS-EVT
- Status last verified
- Aug 2023
- First submitted
- 30 Jul 2023
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Predictive Value of the Global Limb Anatomic Staging System (GLASS) in EndoVascular Therapy (EVT) of Infrainguinal Lesions in Patients With Critical Limb-threatening Ischemia (CLTI): the GLASS-EVT Study
- ClinicalTrials.gov ID
- NCT05999669
- Acronym / sponsor ID
- GLASS-EVT
- Conditions
- Peripheral Arterial Disease
- Keywords
- global limb anatomic staging system, infrainguinal Lesion, critical limb-threatening ischemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Second Affiliated Hospital of Soochow University, First Affiliated Hospital of Zhejiang University, First People's Hospital of Hangzhou, Qingdao Haici Hospital, Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology, Fudan University, Huashan Hospital, Xiamen Cardiovascular Hospital, Xiamen University, Chengdu University of Traditional Chinese Medicine
- Study start
- 20 Aug 2023 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Aug 2023 (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.
The Global Vascular Guideline on chronic limb threatening ischemia (CLTI) proposes the Global Limb Anatomic Staging System (GLASS), a new angiographic scoring system to quantify the anatomic severity of infrainguinal disease in CLTI patients. However, GLASS validation still needs to be completed, and the infrapopliteal (IP) target artery pathway (TAP) was easily influenced by the procedures. Thus the IP target artery could be selected either as the least diseased artery based on angiography or prospectively based on the angiosome concept. So the investigators aim to evaluate its correlation with clinical outcomes after revascularization.
Detailed description
The Global Vascular Guideline on chronic limb threatening ischemia (CLTI) recommends using the Global Limb Anatomic Staging System (GLASS) to assess the severity of infrainguinal disease in CLTI patients. GLASS staging involves scoring the femoropopliteal (FP) and infrapopliteal (IP) segments separately. For IP segment scoring, the target artery path (TAP) is identified by the clinician based on either the least diseased or the recanalized IP path. However, this approach may lead to diverse GLASS staging results, especially for simple lesions below the knee. Additionally, the current version of GLASS does not account for multivessel IP revascularization, which may introduce subjective bias if a physician chooses different IP targets during multiple revascularization procedures.
In order to improve our understanding of the current staging system, the investigators will establish a prospective registry that collects data on conservative patients who have Chronic Limb-Threatening Ischemia (CLTI) and undergo endovascular therapy for infrainguinal lesions. To evaluate the stage of the lesions, the investigators will use two distinct IP scoring techniques. One approach will be based on the least disease IP path as identified by the pre-interventional angiogram, while the second technique will be based on the recanalized IP path preferred by the clinician. This scoring will be carried out by experienced physicians and the results will be recorded in an electronic database. Then the correlation between the major adverse limb events (such as clinical-driven target limb revascularization, major amputation, and all-cause death) with the patient's Wound, Ischemia, foot Infection (WIFI) classification, GLASS anatomic staging, calcification severity, and modified Society for Vascular Surgery (SVS) run-off score will be analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with infrainguinal lesions suffering from critical limb-threatening ischemia
Key inclusion criteria (2 listed)
- Clinical diagnosis of chronic limb-threatening ischemia (CLTI)
- Undergo endovascular therapy for infrainguinal lesions
Key exclusion criteria (4 listed)
- Pregnant women or female patients with potential childbearing
- Patients who have acute limb thromboembolism or require thrombectomy during the procedure
- Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion)
- Patients with known allergy to contrast media
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLASS staginguse the Global Limb Anatomic Staging System (GLASS) to evaluate its correlation with clinical outcomes after revascularization | Other | – |
Primary outcome
Rate of freedom from major adverse events (MAEs)
Time frame: 12-month
Major adverse events (MAEs) is defined as index limb amputation above the ankle, clinical-driven target lesion revascularization (CD-TLR), or all-cause death
5 secondary outcomes
Rate of acute procedure success
Time frame: 72-hour after procedure
Rate of freedom from clinical-driven target lesion revascularization (CD-TLR)
Time frame: 24-month
Rate of freedom from major adverse events (MAEs)
Time frame: 24-month
Primary sustained clinical improvement assessed by Rutherford classification
Time frame: 24-month
Change of quality of life assessed by Vasc quality of life scale
Time frame: 24-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: Undecided
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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.
Meng Ye, M.D. principal investigator
Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by RenJi Hospital.
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 2 inclusion and 4 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: opening soon, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ni Qihong, M.D. (+8615801900772, niqihong1989@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of freedom from major adverse events (MAEs) (time frame: 12-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Aug 2023.