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IVUS Guidance in BTK Interventions

ConditionChronic Limb-Threatening Ischemia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShin Kong Wu Ho-Su Memorial Hospital

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Intravascular ultrasound-guided EVT

    Procedure/Surgery

    Endovascular therapy of the below-the-knee artery is guided by intravascular ultrasound (IVUS) imaging in addition to X-ray angiography, with IVUS used to assess the lesion, size and select devices, optimize treatment, and confirm the final result.

  • Angiography-guided EVT

    Procedure/Surgery

    Endovascular therapy of the below-the-knee artery is guided by X-ray angiography with contrast dye alone, without the use of intravascular ultrasound, to assess the lesion, size and select devices, and judge the final result.

Treatment groups

212 Participants
are divided into 2 treatment groups
Group A: IVUS + Angiography-guided EVTExperimental treatment 1 intervention
Group B: Angiography-guided EVTActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Primary patency at 6 months

Freedom from clinically driven target lesion revascularization (CD-TLR), total occlusion of the target vessel, or binary restenosis of the target lesion. Binary restenosis is defined as a peak systolic velocity ratio \>2.0 on duplex ultrasound. Reported as the proportion of participants meeting all three criteria.

Time frame
6 months after the index procedure

Secondary outcomes

1

Major amputation of the study limb

Proportion of participants undergoing major (above-the-ankle) amputation of the study limb.

Time frame
12 months
2

Major adverse limb events (MALE)

Proportion of participants with a major adverse limb event, defined as a composite of above-ankle amputation of the study limb, CD-TLR, or all-cause mortality.

Time frame
12 months
3

Composite freedom from limb events

Proportion of participants free from all of the following: major amputation of the study limb, total occlusion of the target vessel, CD-TLR, and binary restenosis of the target lesion (peak systolic velocity ratio \>2.0 on duplex ultrasound).

Time frame
12 months
4

Wound healing (Rutherford class 5 participants)

Wound healing rate, reported as the proportion of Rutherford class 5 participants with complete healing of the index wound.

Time frame
1, 3, 6, 9, and 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov

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