NL-OMON56490
Not yet recruiting
Not Applicable
The Use of Intravascular Ultrasound (IVUS) in Below-The-Knee (BTK) Arteries: A Randomized Controlled Trial. - TIBA
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sint Antonius Ziekenhuis
- Enrollment
- 52
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* 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.
Exclusion Criteria
- •\* 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
Outcomes
Primary Outcomes
Not specified
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