Outcomes of Atherectomy and Balloon Angioplasty Compared to Conventional Angioplasty in Infra-popliteal Chronic Limb-Threatening Ischemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: atherectomy, Percutaneous transluminal angioplasty of infra-popliteal arteries lesions with primary long.
- Who it may be relevant to
- Registry conditions: Chronic Limb Threatening Ischemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Chronic limb-threatening ischemia (CLTI) represents the most advanced stage of peripheral artery disease (PAD), characterized by rest pain, non-healing ulcers, or gangrene, and is associated with high morbidity and risk of amputation if left untreated. Infra-popliteal arteries are frequently involved in CLTI, especially in diabetic and elderly patients, posing significant challenges due to diffuse, calcified, and long-segment occlusive lesions. Conventional balloon angioplasty remains a first-line endovascular treatment but is limited by high restenosis and vessel recoil rates. Atherectomy, a plaque debulking technique, aims to improve luminal gain and vessel compliance prior to angioplasty, potentially enhancing outcomes in heavily calcified lesions. The combination of atherectomy and balloon angioplasty has shown promise in reducing dissection rates and improving technical success, yet its superiority over conventional angioplasty alone remains controversial. Given the growing use of endovascular therapies, a comparative analysis of outcomes between combined atherectomy-balloon angioplasty and conventional angioplasty in infra-popliteal interventions is essential to guide evidence-based management in CLTI patients.
Interventions
- Device atherectomy
Conventional balloon angioplasty remains a first-line endovascular treatment but is limited by high restenosis and vessel recoil rates. Atherectomy, a plaque debulking technique, aims to improve luminal gain and vessel compliance prior to angioplasty, potentially enhancing outcomes in heavily calcified lesions. The combination of atherectomy and balloon angioplasty has shown promise in reducing dissection rates and improving technical success, yet its superiority over conventional angioplasty al - Device Percutaneous transluminal angioplasty of infra-popliteal arteries lesions with primary long
Percutaneous transluminal angioplasty of infra-popliteal arteries lesions with primary long
Primary outcome measures
- • Compare the 12-month primary patency rate between the two groups. [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
All patients present with CLTI due to isolated infra-popliteal disease with the following criteria:
- Denovo or Recoil
- Reference tibial vessel diameter at least (2mm)
- The diseased tibial artery has a patent distal segment supplying the foot
Exclusion criteria
- Patients present with:
- Previous ipsilateral infrapopliteal bypass surgery
- Concomitant iliac or femoral artery lesion
- Isolated pedal arch disease
- previous atherectomy
- Faliure to cross the lesion
- Known hypercoagulable disorder or non-atherosclerotic vasculopathy
- Severe renal insufficiency (eGFR <30) not on dialysis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07120555 · DFGCUOHBTR