Comprehensive Limb Evaluation and Arterial Revascularization With Toe Pressure Optimization Registry (CLEAR TOE)

University Hospital of Bordeaux

Status: Not yet enrolling

Conditions: Critical Limb Ischemia (CLI)

Treatments: Other: data collection; Procedure: intensive toe pressure evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT07014072

2025-A00272-47 (Registry Identifier)

CHUBX 2025/006

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years
• Rutherford category 4 or 5
• Wounds limited to toes or forefoot with a salvageable limb
• Infrapopliteal lesions (infra-popliteal arteries) with >70% stenosis upon visual assessment during initial angiography

Exclusion criteria

• Previous or planned major amputation of the target limb
• Untreated aortoiliac/femoropopliteal stenotic disease limiting flow
• History of infrapopliteal bypass on the target limb
• Failure of percutaneous transluminal angioplasty of the target limb (technical failure)
• Absence of angiographic evidence of a patent artery below the ankle ("desert foot")
• Lesions located inside or near an arterial aneurysm
• Life expectancy < 1 year
• Acute limb ischemia
• Septicemia or bacteremia

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Historical cohort

Sham Comparator group

Description:

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.

Treatment:

Other: data collection

Prospective cohort

Experimental group

Description:

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:

Treatment:

Procedure: intensive toe pressure evaluation