Calcified Iliac vessels Circulatory System
Conditions
Interventions
This is an observational study, which means it does not change the care that patients receive. Everyone taking part will already have received intravascular lithotripsy (IVL) as part of their normal t
Sponsors
University of Leicester
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Adults aged 18 years or older 2. A diagnosis of symptomatic peripheral arterial disease (PAD), meaning reduced blood flow to the legs causing symptoms such as pain when walking or more severe limb symptoms 3. PAD classified as Rutherford stages 3 to 5, indicating moderate-to-severe symptoms that require treatment 4. Presence of calcified narrowing or blockage of the arteries supplying the pelvis or lower part of the main body artery (femoral, iliac or aorto-iliac arteries), confirmed on routine clinical imaging 5. The patient has already been selected by their treating clinical team to undergo intravascular lithotripsy (IVL) as the primary treatment, as part of their normal NHS or hospital care, independent of the study 6. Treatment with IVL has taken place within routine clinical practice at a participating hospital site 7. The patient is willing and able to provide written informed consent to take part in the study, including consent for the use of their routine clinical data and follow-up information for research purposes These criteria ensure that the study includes patients who would normally receive IVL L6 for calcified femoral, iliac or aortoiliac artery disease without altering clinical decision-making or standard care pathways.
Exclusion criteria
Exclusion criteria: 1. Under 18 years of age 2. Asymptomatic peripheral arterial disease, or PAD, not meeting Rutherford stage 3–5, where treatment with intravascular lithotripsy (IVL) is not clinically indicated 3. No significant arterial calcification in the femoral, iliac or aortoiliac arteries, or where IVL is not considered appropriate by the treating clinical team 4. Patients who do not receive IVL l6 as the primary treatment strategy for the target femoral, iliac or aorto-iliac lesion. 5. Patients in whom an alternative revascularisation strategy is used instead 6. Inability to provide informed consent, including lack of capacity to consent and no appropriate consultee process available. 7. Withdrawal of consent at any time prior to or during the study 8. Patients who are unwilling or unable to participate in follow-up, including refusal of follow-up contact or inability to be contacted by telephone These exclusion criteria ensure that the study population is limited to adults with symptomatic, calcified iliac or aorto-iliac peripheral arterial disease who are able to provide consent and are receiving IVL as part of routine clinical care.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Freedom from major adverse limb events (MALE), defined as a composite outcome including major (above-ankle) lower limb amputation of the target limb, and/or clinically driven target limb reintervention, measured using routinely collected clinical data and standard follow-up, reflecting real-world NHS practice, at 12 months following the index intravascular lithotripsy (IVL) procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Major adverse limb events (MALE) at 30 days and 6 months following the index IVL procedure 2. All-cause mortality at 30 days, 6 months, and 12 months 3. Major adverse cardiovascular events (MACE): composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke at 12 months 4. Limb salvage: freedom from major (above-ankle) amputation of the target limb at 12 months 5. Target limb reintervention: rate and timing of clinically driven reintervention to the target limb within 12 months 6. Procedural success as recorded in routine clinical documentation, gathered on an ongoing basis whilst the participant is in follow-up 7. In-hospital complications related to the index admission at index admission for IVL L6 procedure (baseline) All secondary outcomes will be ascertained using routinely collected clinical data from medical records and standard follow-up, in keeping with the non-interventional, observational nature of the study | — |
Countries
England, United Kingdom
Contacts
Public ContactShared Mailbox
Outcome results
None listed