Is the clinical and cost-effectiveness of open surgery for severe occlusive disease of the aorta and iliac arteries superior to newer endovascular (keyhole) treatment? The EVOCC Trial
- Conditions
- Severe occlusive aorto-iliac diseaseCirculatory System
- Registration Number
- ISRCTN14591444
- Lead Sponsor
- niversity of Leicester
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 628
Main Trial
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method