Outcomes of Atherectomy and Balloon Angioplasty Compared to Conventional Angioplasty in Infra-popliteal Chronic Limb-Threatening Ischemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-12-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Limb Threatening Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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atherectomy + balloon angioplasty

Group Type EXPERIMENTAL

atherectomy

Intervention Type DEVICE

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.

conventional balloon angioplasty

Group Type EXPERIMENTAL

Percutaneous transluminal angioplasty of infra-popliteal arteries lesions with primary long

Intervention Type DEVICE

Percutaneous transluminal angioplasty of infra-popliteal arteries lesions with primary long

Interventions

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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 alone remains controversial.

Intervention Type DEVICE

Percutaneous transluminal angioplasty of infra-popliteal arteries lesions with primary long

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes