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 @ 9:21 PM
Ignite Modification Date:
2025-12-24 @ 9:21 PM
NCT ID:
NCT04801004
Eligibility Criteria:
Inclusion Criteria:
1. Tosaka III In-stent restenosis after stent implantation in PAD patients (Including acute and subacute thrombotic lesions).
2. Rutherford grade 2-5.
3. Stents should be located in the femoropopliteal artery.
4. The stenosis of iliac artery on the affected side is less than 30% or the residual stenosis after treatment is less than 30%.
5. Informed consent has been signed
Exclusion Criteria:
1. Tosaka I or II in-stent restenosis.
2. Stents are located in iliac artery or artery below the knee, or the preoperative CTA showed type 3 or 4 stent fracture.
3. Rutherford Grade 6.
4. Thromboangiitis obliterans (TAO)-based, arteritis-based or connective tissue disorder-based FP-ISR.
5. Intraoperative conversion to hybrid or open surgery.
6. Patients refusing to sign informed consent forms.
7. Life expectancy of patients is less than 12 months.
8. The pregnant or nursing patients.
9. The patients with severe ischemia of lower extremity who would receive major amputation in plan.
10. Patients in whom antiplatelet or anticoagulant therapy is contraindicated.
11. Myocardial infarction or stroke within 3 months prior to enrolment.
12. Patient with known allergy to contrast agents or medications used to perform endovascular intervention.
13. Patients participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
14. Patients who refuse to cooperate with long-term follow-up or who have difficulty communicating.
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04801004
Study Brief:
Protocol Section:
NCT04801004