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 @ 9:18 PM
Ignite Modification Date:
2025-12-24 @ 9:18 PM
NCT ID:
NCT05822804
Eligibility Criteria:
Inclusion Criteria:
* Age 18-80, male or non-pregnant female;
* Subjects undergoing unilateral femoral artery retrograde puncture for angiography or interventional procedure;
* Using guide sheath ≥5F to ≤8F, and length ≤12cm in angiography or interventional procedure;
* Subjects or their legal guardians voluntarily participate in this study, can complete follow-ups, and sign the informed consent form.
Exclusion Criteria:
* Ipsilateral common femoral artery occlusion or lumen diameter \< 5mm;
* Inability to walk;
* Allergy to contrast media;
* Allergy to PGA or PEG; subjects with a history of common femoral artery surgery, percutaneous transluminal angioplasty (PTA), stent implantation, or vascular graft;
* Subjects with bleeding tendency, such as thrombocytopenia (platelet count \<100×109/L), hemophilia, von willebrand diseases, pre-procedure INR \>1.5, etc.;
* Subjects have taken anticoagulants for a long term before the procedure and have blood coagulation disorders;
* BMI \>40kg/m\^2;
* Subjects receive thrombolytic therapy (such as streptokinase, urokinase, t-PA) within≤24 hours before vascular closure;
* Local infections or skin infections of the investigational limb;
* Subjects with target femoral artery dissection or aneurysm within 30 days before intervention procedure;
* Subjects with puncture site have been punctured through the posterior wall of the femoral artery, or have been punctured several times (≥3 times), or have bleeding or hematoma on the femoral artery puncture site during the procedure;
* Subjects with clinically significant peripheral vascular diseases (such as severe calcification, arteritis, stenosis, etc) near the puncture site;
* Women who are pregnant or breastfeeding, OR men or women who plan to have a child in the next 6 months;
* Subjects who are enrolled in other clinical trials and don't complete;
* Subjects are considered not suitable for enrollment by the investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05822804
Study Brief:
Protocol Section:
NCT05822804