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 @ 11:29 PM
Ignite Modification Date:
2025-12-24 @ 11:29 PM
NCT ID:
NCT02710656
Eligibility Criteria:
Inclusion Criteria:
1. Patient must sign the informed consent form prior to the index-procedure.
2. Patient must be older than 18 years.
3. Patient with Rutherford 2, 3 and 4..
4. Target lesion is an occlusion or ≥70% stenosis (visual estimate) located in SFA or popliteal artery (P1 -P2).
5. Maximum length of the target lesion is 13 cm.
6. Target lesion is TASC A, B or C.
7. Target lesion is a de novo lesion or restenotic lesion (previously POBA treated, in-stent restenosis is not allowed).
8. Inflow arteries are free from hemodynamically significant obstruction (i.e. ≥ 50% diameter stenosis). It is allowed to treat inflow lesions during the index-procedure if the result is ≤ 30% diameter stenosis (treatment with DCB or DES is not allowed). Treatment of a non-target lesion in the target vessel is allowed if the nontarget lesion is considered to be an inflow lesion.
9. Popliteal artery P3 segment (below knee popliteal artery) is free from hemodynamically significant obstruction (i.e. ≥ 50%). Treatment of a lesion in this segment is not allowed during the index-procedure.
10. At least 1 patent (\< 50% diameter stenosis) below-the-knee vessel (anterior tibial artery, posterior tibial artery or peroneal artery) till the ankle as confirmed by baseline angiography.
Exclusion Criteria:
1. Patient is already included in this study (recruitment of the contralateral leg is not allowed).
2. Patient has a known intolerance to antiplatelet therapy or contrast agent.
3. Patient with known sensitivity to Paclitaxel.
4. Patient is pregnant or patient intends to become pregnant within 1 year after the index-procedure.
5. Patient takes esomeprazole or omeprazole.
6. Patient with serum creatinine \>2.0 mg/dL or renal dialysis.
7. Patient suffers from acute limb ischemia defined as any sudden decrease in limb perfusion causing a potential threat to limb viability.
8. Patient has a life expectancy \<2 years.
9. Patient with Rutherford 0, 1 , 5 and 6.
10. Patient has a target lesion that is severely calcified (grade 3 and grade 4).
11. Patient with a TASC D lesion.
12. Patient has an acute thrombus or aneurysm in the target vessel.
13. Patient has a target lesion that cannot be crossed with a guidewire.
14. Target vessel has been treated previously with a DCB or a DES.
15. Treatment of outflow lesions during the index-procedure.
16. Patients with significant disease of all 3 infrapopliteal vessels (i.e. ≥ 50% diameter stenosis in each vessel).
17. Any scheduled surgery within 3 months after the index-procedure that would necessitate the discontinuation of clopidogrel.
18. Patients with previous bypass surgery involving the SFA.
19. Patient has cirrhosis of the liver.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02710656
Study Brief:
Protocol Section:
NCT02710656