se of ultrasound lithotripsy to treat calcified peripheral arterial disease

Phase 3

Completed

• Conditions: Peripheral arterial disease; Circulatory System

• Registration Number: ISRCTN76218607
• Lead Sponsor: niversity of Leicester

Brief Summary

2024 Results article in http://doi.org/10.54522/jvsgbi.2024.126 (added 20/06/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-28
• Study Completion: 2023-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 99

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified