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:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT06149650
Eligibility Criteria:
Inclusion Criteria:
* Patient with chronic limb-threatening ischemia (Rutherford Category ≥4)
* Femoropopliteal and/or crural calcified lesions visible on fluoroscopy;
* Treatment with IVl using the Shockwave Medical IVL System.
Exclusion Criteria:
* \< 18 years old;
* Incapacity or refusal to give informed consent;
* Ongoing pregnancy;
* Endovascular procedure(s) on the treatment site within 4 weeks before the planned IVL treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06149650
Study Brief:
Protocol Section:
NCT06149650