Chronic limb-threatening ischemia, critical limb ischemia, Peripheral artery disease, arterial stenosis Poor blood circulation in the legs, leg circulation problems, narrowed or blocked leg arteries, severely reduced blood flow to the legs
Conditions
Interventions
The intervention under investigation is the post-procedural follow-up strategy:In the proactive group, patients will undergo scheduled duplex ultrasound examinations at 2 and 6 weeks, and at 3, 6, 12,
3.0),  
it will be mandatory to be treated. 
In the reactive group, imaging and intervention will only occur when clinical signs or symptoms suggest recurrence (e.g., wound deterioration, new ischemic pain).Patient in both groups receive standar
The additional scheduled duplex imaging (and possible consequence of early intervention) is the only difference in the proactive group. 
Sponsors
Noordwest Ziekenhuisgroep
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Technically succesful revascularization of the femoropopliteal vascular segment up to the P3 segmentPatients diagnosed with chronic limb threatening ischemia: rutherford class 4,5 or 6Revascularization performed via open surgical and/or endovascular techniquesAdequate proficiency in DutchSigned written informed consent
Exclusion criteria
Exclusion criteria: Presence of a femoral or popliteal aneurysm larger than 2 cm in the index limbPlanned above-ankle amputation on the ipsilateral limb within 4 weeks of the initial revascularizationActive vasculitis, Buerger’s disease, or acute limb-threatening ischemia (symptom duration <14 days)Repeated endovascular treatment on the index limb within the last 3 months prior to enrollmentOpen surgical inflow procedure (e.g., aortofemoral, axillofemoral, iliofemoral, thoracofemoral, or femorofemoral bypass) within 6 weeks prior to enrollmentOngoing chemotherapy or radiation therapy at the time of inclusionSevere perioperative or acute postoperative complications following revascularization(e.g. bleeding requiring reintervention, perioperative myocardial infarction, stroke, or early graft/stent failure)Life expectancy <2 years due to a condition other than peripheral artery disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint: the primary outcome is a composite of major adverse limb events or death from any cause. A major adverse limb event is defined as above-ankle amputation of the index limb or a major index limb reintervention (new bypass, open surgical revision, thrombectomy, or thrombolysis). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: individual components of the composite primary endpoint (above-ankle amputation and major index-limb reintervention), limb salvage, serious adverse events within 30 days of reintervention, major adverse cardiac events, healthcare costs, general health status and quality of life and disease-specific quality of life (VascuQoL-6). | — |
Countries
Netherlands
Contacts
Public ContactS Ampalavanar
Noordwest Ziekenhuisgroep
Outcome results
None listed