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:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT02540018
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years
2. Subject must agree to undergo the 6-month angiographic and clinical follow-up (at 12 month post-procedure)
3. Peripheral vascular disease Rutherford class 2-4
4. De novo stenotic/re-stenotic lesion or occlusive lesions in the superficial femoral (SFA) and/or popliteal arteries (PA)
5. If the index lesion is re-stenotic, the prior PTA must have been \>30 days prior to treatment in the current study
6. ≥70% diameter stenosis or occlusion
7. Target lesion length: ≤15 cm (TASC II A and B)
8. Only one lesion per limb and per patient can be treated (see definition chapter 6.5)
9. ≥ one patent intrapopliteal run-off artery to the foot of the index limb
10. Successful endoluminal guidewire passage through the target lesion
11. Predilatation prior to randomization
12. Life expectancy, in the investigators opinion of at least one year
13. Subject is able to verbally acknowledge and understand the aim of this trial and is willing and able to provide informed consent
Exclusion Criteria:
1. Previous surgery in the target vessel
2. Major amputation in the same limb as the target lesion
3. Presence of aneurysm in the target vessel
4. Acute myocardial infarction within 30 days before intervention
5. Severely calcified target lesions in the SFA/PA resistant to PTA
6. Subjects requiring different treatment or raising serious safety concern regarding the procedure or the required medication
7. Women of childbearing potential expect women with the following criteria:
* post-menopausal (12 month natural amenorrhea or 6 month amenorrhea with serum FSH \> 40mlU/ml)
* sterilization 86 weeks after bilateral ovariectomy with or without hysterectomy
* using an effective method of birth control for the duration of the trial: implants, injectables, combined oral contraceptives, intrauterine device (in place for a period of at least 2 months prior to screening) and with negative serum pregnancy test
* sexual abstinence
* vasectomy partner
8. Pregnant and nursing women
9. Acute thrombus, stent or aneurysm in the index limb or vessel
10. Renal insufficiency with a serum creatinine \>2.0 mg/dL at baseline
11. Platelet count \<50 G/l or \>600 G/l at baseline
12. Known hypersensitivity or contraindication to contrast agent that cannot be adequately pre-medicated
13. Subjects with known allergies against Paclitaxel
14. Subjects with intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would be administered during the trial
15. Dialysis or immunosuppressant therapy
16. Current participation (or within the last 3 months) in another interventional study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02540018
Study Brief:
Protocol Section:
NCT02540018