Patients with peripheral artery disease will be treated with either drug coated balloon catheter, drug coated stent or uncoated stent.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* PAOD and Rutherford classes 2 - 4 (pain-free walking distance \<500 m)
* eligible for peripheral revascularization by means of PTA
* peripheral lesions in the superficial femoral artery (SFA) and / or the PI-segment of the popliteal artery (A.pop.)
* minimum diameter stenosis of ≥70%
* treatment length at least 15 cm (lesion length at least 13 cm)
* maximum of lesions to be treated should be 2 (all treated lesions should be treated within the randomization to the study group, i.e. either coated balloon catheters or coated stents or bare nitinol stents); in case of two lesions matching the eligibility criteria, the one presenting the worst attributes (length and stenosis degree) should be chosen as target lesion
* long diffuse stenosis with or without occlusions may only be divided in separate lesions if non-stenotic (i.e. \<50% stenosis) segments in between the lesions extent to \>2 cm, otherwise vessel segments will be treated as a single extended lesion
* eligible for an operative vascular intervention in case of complications during the PTA
Exclusion Criteria:
* Rutherford class 1,5 or 6
* more than two stenotic lesions in the target vessel requiring treatment
* inflow lesion (proximal to the study lesion) with flow limitation not being successfully treated prior to the study lesion
* in-stent restenosis of the study lesion
* strongly calcified lesions with circumferential presence of calcifications and a lesion calcification length of \>4 cm
* ref…
What they're measuring
1
Percent diameter stenosis at 1 year post intervention in successfully treated patients