The Use of Intravascular Ultrasound (IVUS) in Below-The-Knee (BTK) Arteries: A Randomized Controlled Trial.
- Conditions
- Critical Limb Ischemia (CLI)narrowed arteries10003216
- Registration Number
- NL-OMON56490
- Lead Sponsor
- Sint Antonius Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 52
* Age >18 years old;
* CLTI, defined as the presence of PAD in combination with rest pain, gangrene,
or a lower limb ulceration >2 weeks duration;
* Indication for BTK endovascular revascularization, as set by the
multidisciplinary team;
* De novo vascular target lesion;
* Written informed consent.
* Target lesions with a length of <5 cm or >20 cm;
* Kawarada Type III pedal arch (no patent dorsalis pedis artery, no patent
plantar artery);
* Below-the-knee (BTK) critical limb ischemia (CLTI) based on acute thrombosis
or thrombo-emboli;
* Renal insufficiency with a glomerular filtration rate (GFR) of less than 15
ml/min but not on dialysis;
* Contrast allergy;
* Non-salvageable limbs due to extensive tissue necrosis or infection
(Rutherford classification of chronic limb ischemia 6 or WiFi classification
wound score 3);
* ASA-classification of IV or higher;
* Ejection fraction <30%;
* MAC score >2;
* Target lesions not amenable for endovascular treatment by operators* decision
after baseline angiography (Angio-1);
* Pregnancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is NLG following IVUS-guided intervention when compared<br /><br>with angiography-guided intervention after six weeks. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints include ALG and per-procedural complications such as<br /><br>arterial dissections.</p><br>