Clinical trial NCT07014072: Comprehensive Limb Evaluation and Arterial Revascularization With Toe Pressure Optimization Registry
Official title: Comprehensive Limb Evaluation and Arterial Revascularization With Toe Pressure Optimization Registry
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Critical Limb Ischemia (CLI)
Keywords: CLTI
toe pressure
limb salvage
endovascular revascularization
theatening
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Toe pressure with Systolic pressure measurement device
timeFrame: Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Secondary outcomes:
measure: Evaluation of Survival
timeFrame: Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Evaluation of the absence of target lesion occlusion.
timeFrame: Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Evaluation of target lesion revascularization
timeFrame: Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Evaluation of major adverse limb events
timeFrame: Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Evaluation ofthe Wound healing with WiFi classification
timeFrame: Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
measure: Evaluation of the Wound healing with colorimetry scale
timeFrame: Day 15, Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Centre Hospitalier Universitaire de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Eric DUCASSE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: