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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00272-47 | Registry Identifier | Enregistrement RCB - Agence nationale de sécurité du médicament et des produits de santé - FRANCE |
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To address the heterogeneity of practices, better understand the outcomes of cricital limb theatening ischemia (CLTI) patients after endovascular interventions, and recognize effective endovascular options for infrapopliteal artery revascularization in CLTI, our prospective registry aims to tackle the critical question of whether intensive toe pressure evaluation, guiding repeat revascularization using predetermined thresholds (<30 mmHg or decrease >10% from immediate postoperative assessment), could optimize outcomes in patients with CLTI.
Cricital limb theatening ischemia (CLTI) represents the most advanced stage of peripheral arterial disease (PAD), leading to high mortality rates and limb loss. A primary endovascular strategy is now preferred for most patients with CLTI who have occlusive disease of the tibial arteries. This is especially true for the elderly, diabetic patients, and those without suitable venous conduits for bypass. Patients with CLTI and infra-popliteal occlusive disease do not always respond well to the provided treatment, but the underlying reasons, particularly in those showing good initial results after endovascular revascularization, remain to be determined.
The literature strongly supports the use of drug-eluting stents (DES) in treating infrapopliteal arteries. DES are associated with significant improvements in patency, reduced rates of restenosis and reintervention, and better Rutherford-Becker classification and healing of trophic disorders. However, contrary to initial expectations, the SAVAL trial, whose data were made public in December 2023, comparing a DES dedicated to infra-popliteal arteries with percutaneous transluminal angioplasty in patients with CLTI, failed to meet its primary efficacy (increased primary patency and reduced major adverse events rate) and safety objectives at 12 months, despite preliminary data suggesting an advantage in using DES for treating short lesions. A possible explanation is the significant heterogeneity of practices, with less than half of the patients receiving optimal medical treatment and intensive follow-up, highlighting the need for a comprehensive review of treatment strategies in this challenging patient population.
The lack of an established objective follow-up protocol for this patient group underscores the need for innovative approaches. Currently, there is no widely available consensus indicator to estimate whether the revascularization provided will be sufficient to prevent amputation. The Delta-Perf study has completed its recruitment and is expected to provide results on foot perfusion analysis in patients with CLTI before and after revascularization and its predictive value on amputation-free survival. However, despite high initial technical success rates for endovascular interventions, early failure of these minimally invasive procedures is common.
Current recommendations support duplex scan monitoring and prophylactic reintervention for asymptomatic graft stenosis to promote long-term patency, but monitoring and reintervention strategies after endovascular management have been left to the practitioner's discretion. There are no ongoing studies to determine if the initial improvement observed in the foot is actually maintained, and there is little evidence to support indications for repeated interventions in CLTI. Clinical follow-up alone may be insufficient to detect restenosis, as patients may remain asymptomatic until the target artery is occluded, similar to venous grafts in bypasses. Likewise, measuring the ankle-brachial index (ABI) alone has limited value, given the difficulty in determining the level of restenosis, technical limitations in diabetic patients with calcified vessels, and variability in correlation with the severity of lesions.
It is likely that there are subgroups of patients who could benefit more than others from early reintervention. Toe pressure, in this context, offers a measurable, non-invasive, and clinically relevant parameter that can be consistently evaluated even in challenging cases, particularly in heavily calcified patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Historical cohort | Sham Comparator | 100 patients with CLTI treated in the past 3 years at the same center. Patients in this cohort were treated according to standard clinical practices at the time, without intensive toe pressure evaluation to guide reinterventions, and with reinterventions guided solely by clinical criteria. |
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| Prospective cohort | Experimental | 100 patients included prospectively and treated as part of the study. Patients in this cohort will be followed with an intensive toe pressure evaluation approach (TcPO2), guiding reinterventions according to predetermined thresholds (<30 mmHg or decrease >10% from immediate postoperative assessment). This cohort will receive best medical treatment: |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intensive toe pressure evaluation | Procedure | This measurement is non-invasive, painless and is also carried out as part of the care in the follow-up of critical limb ischemia. It takes place like a blood pressure measurement except that it is carried out at the level of a toe. |
| Measure | Description | Time Frame |
|---|---|---|
| Toe pressure with Systolic pressure measurement device | The Systolic pressure measurement device is suitable for the toes, as part of the diagnosis or monitoring of obliterating arteriopathy of the lower limbs, as for the fingers of the hand during assessments relating to arteriovenous fistulas. The Systolic pressure measurement device ingeniously uses photoplethysmography (PPG) associated with a unique algorithm developed and patented by Atys Medical. PPG makes it possible to detect, thanks to a photoelectric cell (sensor), variations in blood flow in skin traffic. The Systolic pressure measurement deviceputs the measurement of digital pressure pressure within the reach of all the stakeholders concerned (angiologists, nephrologists, diabetologists, vascular surgeons, wound and healing services, etc.). | Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Survival | Describe if patient is alive or not | Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 |
| Evaluation of the absence of target lesion occlusion. | Evaluation of absence of occlusion of the target lesion by Echo-doppler |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric DUCASSE, MD, PhD | Contact | +335 56 79 55 25 | eric.ducasse@chu-bordeaux.fr | |
| Olivier Delorme | Contact | +335 57 82 01 34 | olivier.delorme@chu-bordeaux.fr |
| Name | Affiliation | Role |
|---|---|---|
| Eric DUCASSE, MD, PhD | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire de Bordeaux | Bordeaux | 33000 | France |
The data is available from Pr DUACSSE. An email can be sent to her so that she can contact the data manager and owner, the Bordeaux University Hospital. The data can be made available after contractual agreement
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| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| data collection | Other | retrospective data |
|
| Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 |
| Evaluation of target lesion revascularization | Evaluation of target lesion revascularization using Echo doppler | Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 |
| Evaluation of major adverse limb events | Evaluation of major amputation or major reinterventions including new bypass surgery, bypass revision, or thrombectomy/thrombolysis related to the target lesion | Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 |
| Evaluation ofthe Wound healing with WiFi classification | It takes into account the patient's foot wound, ischemia and infection. This system can be used to determine the estimated 1-year risk of amputation and the estimated probability of benefit/need for revascularization. It is a useful, standardized tool that can help determine patient risk and the need for intervention. | Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 |
| Evaluation of the Wound healing with colorimetry scale | Colorimetry involves analyzing the different colors present in a wound to determine its condition and stage of healing. Each color corresponds to a specific tissue or biological process. | Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |