Peripheral arterial disease Circulatory System
Conditions
Interventions
Once a participant has consented to take part, the study team will collect information about their medical and surgical history as well as clinical presentation. Further, details regarding their intra
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients: 1. Adults (>18 years of age) 2. Diagnosed with symptomatic PAD (severe incapacitating intermittent claudication or chronic limb-threatening ischaemia - Rutherford stages 4–6) 3. Referred to secondary care to undergo lower limb revascularisation using intravascular lithotripsy 4. Able to understand written and spoken English 5. Willing and able to give written informed consent for participation in the study Healthcare professionals: The clinicians who have performed the intravascular lithotripsy procedure on participants included in this research study
Exclusion criteria
Exclusion criteria: Patients: 1. Female participants who are pregnant, lactating or planning pregnancy during the course of the study 2. Patients who do not have the capacity to consent for themselves 3. Patients with a life-limiting condition where conservative management is most appropriate 4. Patients with asymptomatic PAD 5. Patients with acute lower limb-threatening lower limb ischaemia 6. Patients not being referred for lower limb revascularisation using intravascular lithotripsy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patency of the treated arterial atherosclerotic lesion measured using duplex ultrasound at 6 months after the procedure has taken place | — |
Secondary
| Measure | Time frame |
|---|---|
| Baseline (pre intravascular lithotripsy) data collection: 1. Demographic information (age at time of recruitment, sex) 2. Weight/height, resting BP (anthropometric measurements) 3. Rutherford stage relating to PAD presentation 4. Ankle-brachial pressure index measured using a blood pressure cuff 5. Baseline full blood count results and routine biochemistry, including total cholesterol levels, and lipid profile measured using patients' existing blood tests 6. Baseline serum creatinine and estimated glomerular filtration rate measured using patients' existing blood test 7. Chronic kidney disease status measured using estimated glomerular filtration rate 8. Diabetes status, duration of diabetes history, and current diabetes medication(s) measured using patients' notes 9. History of previous major cardiovascular events measured using patients' notes 10. Results of cross-sectional imaging relating to the arterial vasculature e.g. duplex or computed tomographic angiography* 11. Smoking status 12. WiFi score 13. Previous operations, including a full surgical and vascular history measured using patients' notes 14. All concomitant medications as reported by patients 15. Anonymised minutes from multi-disciplinary team meetings relating to the patient's care Day of procedure (post intravascular lithotripsy) data collection: The data collected here will relate to information obtained during the intravascular lithotripsy 1. Exact location of the lesion treated measured using the intra-operative images 2. Number and size(s) of intravascular lithotripsy catheters used measured using the intra-operative images 3. Duration of intravascular lithotripsy application per arterial site in seconds measured using patients' operation notes 4. Exact anatomy (number of occlusions or stenoses) of the arterial lesions present on intra-operative angiography 5. Nature of the additional surgical or endovascular treatments taking place measured using patients' notes 6. Duration of the whole proce | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactSarah Finch
Outcome results
None listed