About this trial
Chronic limb-threatening ischemia (CLTI) is a severe form of peripheral artery disease in which very poor blood flow in the arteries below the knee can cause rest pain, non-healing wounds, and even loss of the limb. It is often treated with endovascular therapy (EVT), a minimally invasive procedure that opens the blocked artery, but the artery frequently narrows or closes again afterward. These procedures are usually guided by X-ray pictures taken with dye (angiography). Intravascular ultrasound (IVUS) is an imaging tool that uses a small catheter inside the artery to give a more detailed view of the vessel, which may help doctors open it more completely. It is not yet clear whether adding IVUS improves results below the knee.
This study is testing whether guiding treatment with IVUS plus angiography keeps the artery open better than angiography alone. Adults aged 18 or older with CLTI who are having endovascular therapy for a blocked artery below the knee may take part. Participants are assigned by chance to be treated with either both imaging methods or angiography alone, and are followed for 12 months. The main question is how well the treated artery stays open at 6 months; researchers will also compare repeat procedures, amputation, complications, wound healing, survival, and quality of life.
Eligibility criteria
Qualifiers
Age ≥18 years.
Presence of ischemic symptoms compatible with CLTI, defined as arterial insufficiency with gangrene, non-healing ischemic ulcer, or rest pain consistent with Rutherford classes 4-5 AND
Imaging evidence within the past 12 months showing atherosclerotic PAD, including CTA, MRA, angiography or duplex ultrasound AND
Ankle-Brachial Index (ABI) ≤0.80 or Toe-Brachial Index (TBI) ≤0.60 for patients who never underwent revascularization; ABI ≤0.85 or TBI ≤0.65 for those with history of prior revascularization procedures OR
Disqualifiers
Age <18 years
Asymptomatic or mild disease: patients who underwent revascularization for disease graded Rutherford classes 0-3
Patients with major tissue loss (Rutherford 6) in whom major amputation was planned at the time of screening
Patient with a history of prior major (above-the-ankle) amputation of the study limb
Trial design
Treatments tested in this trial
- Intravascular ultrasound-guided EVT
- Angiography-guided EVT
Treatment groups
Sponsors and collaborators
Shin Kong Wu Ho-Su Memorial Hospital
Lead sponsor
National Taiwan University Hospital
Collaborator
Chi Mei Medical Hospital
Collaborator
Chang Gung Memorial Hospital
Collaborator
Taipei Veterans General Hospital, Taiwan
Collaborator