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 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT06636968
Eligibility Criteria:
Inclusion Criteria:
* Patients older than 18 years
* Rutherford scale: Grades 2-5.
* Moderate-severe calcification of lower extremity arteries (defined as calcification on both sides of the arteries, the length of the lesion greater than 5cm).
* The stenosis degree of the lesions was more than 70% confirmed by DSA, including chronic occlusive lesions.
* At least one sub-knee branch artery is patent (defined as a run-off score of 1 or less). • In-stent restenosis or restenosis with moderate to severe calcification.
* The stenosis degree of inflow blood vessel on the diseased side is less than 30% or the residual stenosis is less than 30% after first-stage treatment.
* Calcification lesions with thrombus can also be included in the group after the thrombus is completely cleared.
* Sign relevant informed consent.
Exclusion Criteria:
* Active infection of the affected limb.
* Patients with severe ischemia of the affected limb who are expected to undergo major amputation.
* The target blood vessels were artificial blood vessels or autologous vessels.
* Simple thrombosis lesion.
* Thromboangiitis obliterans, arteritis or connective tissue disease-based lesions.
* Inflow vessel stenosis is greater than 30% or residual stenosis is still greater than 30% after primary treatment.
* Allergic to contrast agent, heparin, anti-platelet therapy.
* Patients who are pregnant or lactating.
* Patients with cardiovascular and cerebrovascular events such as stroke or myocardial infarction within 3 months prior to enrollment.
* Patients who are currently in an ongoing interventional clinical study program.
* Patients who refuse to sign informed consent. •
* Patients who refuse to cooperate with long-term follow-up after surgery or who, for personal reasons, have difficulty communicating for quality of life assessment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06636968
Study Brief:
Protocol Section:
NCT06636968