A randomised controlled trial assessing the clinical and cost-effectiveness of Endovascular vs. Open revascularisation in severe oCClusive aorto-iliac disease. The EVOCC Trial

niversity of Leicester0 个研究点目标入组 628 人开始时间: 2023年8月2日最近更新: 2023年10月3日

试验速览

暂无简介。

•1. Age > = 18 years (no upper age limit)
•2. Presence of symptomatic PAD (tissue loss and/or rest pain and/or lifestyle limiting claudication)
•3. Severe aorto-iliac occlusive PAD defined as Inter-Society Consensus for the Management of Peripheral Arterial Disease” (TASC II) class C or class D
•4. Patient discussed in a local vascular Multi-Disciplinary Team (MDT) meeting and deemed suitable for open surgery or endovascular treatment.
•5. Patient willing and able to give consent and commit to study follow-up.
•6. An ability to understand written English or availability of a translator to explain the trial documentation
•Communication Study (Patients)
•1. Patient willing and able to give consent
•2. An ability to understand written English or availability of a translator to explain the study documentation
•3. Involved with research visits with nurses and/or doctors that have provided consent for the HCP Communication Study (where related to audio-recording of research visits)
•Communication Study (Healthcare Providers)
•1. Willing and able to give consent
•2. Involved with research visits with patients that have provided consent for the Communication Study (where related to audio-recording of research visits)

•Allergy to iodinated intravascular contrast agent including: Iopromide, Iodamide, Iohexol, ioversol, Ioxilan, Iopamidole.

发起方

niversity of Leicester