Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-26 @ 11:00 AM
NCT ID:
NCT06702306
Eligibility Criteria:
Inclusion Criteria:
* Adults (18y+) who have had successful lower limb endovascular therapy (angioplasty, stenting, atherectomy, lithotripsy, drug eluting balloon or stent, or combination of above) for chronic limb threatening ischaemia (ischaemic rest pain, ulceration or gangrene with arterial imaging confirming peripheral arterial disease). Technical success is defined as \<30% residual stenosis in the treated segments and patient leaving hospital without a major (above ankle) amputation on study leg
* Procedures within the last 3 weeks
* Interventions to iliac, femoral, tibial, and pedal vessels alone or in combination
* Endarterectomy or cutdown is permissible
* Able to give informed consent
Exclusion Criteria:
* Surgical bypass or endarterectomy alone undertaken
* Patient unfit for or does not want any future revascularisation
* Need for major amputation due to gas gangrene, severe Charcot deformity, extensive tissue loss with unstable foot, severe pedal disease on angiography or patient request
* Patient unwilling or cannot attend further surveillance
* Interventions for claudication or acute limb ischaemia or trauma
* Patients unable to take any form of antiplatelet therapy (aspirin or clopidogrel)
* Prior leg endovascular therapy at same anatomical location in study leg (within 1 year)
* Currently taking part in research that may impact on the results, design, or scientific value of this study or other studies that the potential participant may be taking part in.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06702306
Study Brief:
Protocol Section:
NCT06702306