IVUS Guidance in BTK Interventions

Inclusion criteria

• Age ≥18 years.
• Documented chronic limb-threatening ischemia, meeting the following criteria according to guidelines(13):

• 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
• Ischemic rest pain alone (Rutherford class 4) with ankle systolic pressure <50 mmHg, toe pressure of <30 mmHg, transcutaneous PO2 of <30 mmHg, or flat-line transtarsal pulse volume recording OR
• Tissue loss with or without ischemic rest pain (Rutherford class 5) with ankle systolic pressure <70 mmHg, toe pressure of <50 mmHg, transcutaneous PO2 of <30 mmHg, or flatline transtarsal pulse volume recording
• Absence of occlusive upstream disease, defined by the following:

• Demonstrated vascular patency from the aorta to the second segment of the popliteal artery (P2), either by angiography, duplex ultrasound, CTA or MRA within the last 7 days prior to randomization
• In patients who underwent prior treatment for upstream disease, there are no restrictions in treatment modalities received as long as patency is demonstrated as previously defined
• If upstream disease is planned to be treated in the same index procedure, technically successful treatment of the upstream vessels must be achieved before randomization, defined as less than 30% residual stenosis and no flow-limiting dissections
• Informed Consent:

• Demonstrated ability and willingness to adhere to the study protocol and provide written informed consent

Exclusion criteria

• 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
• Unable to tolerate any antiplatelet agent or with severe bleeding diathesis
• Clinical signs of active, uncontrolled, severe limb infection or septicemia, defined as fever exceeding 38.5°C, a white blood cell count above 15,000 cells/µL, or hypotension, at the time of screening (this does not include osteomyelitis confined to the phalanges or metatarsal heads or foot cellulitis treatable with IV antibiotics at the time of revascularization)
• Acute coronary syndrome or acute stroke within 30 days of screening
• Active hepatitis or severe liver cirrhosis (Child Pugh C)
• Advanced CKD (defined with eGFR<30 mL/min/1.73m2) or end-stage renal disease
• Pregnancy, breastfeeding, or women of childbearing potential who are not using an effective method of contraception
• Previous (within 30 days) or concomitant participation in another clinical study with investigational medicinal product(s) that has not yet reached its primary endpoint
• Life expectancy <1 year