The objective of this clinical study is to evaluate, in a controlled setting, the long-term (up to 24 months) outcome of the self-expanding nitinol rapid-exchange Misago (Terumo) stent in TASC A and B iliac lesions.
Study Type
OBSERVATIONAL
Enrollment
100
Misago iliac stent
Imelda Hospital
Bonheiden, Antwerp, Belgium
AZ Sint-Blasius
Dendermonde, East-Flanders, Belgium
UZ Gent
Ghent, East-Flanders, Belgium
St Franziskus Hospital
Münster, North Rhine-Westphalia, Germany
Primary patency, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without Target Lesion Revascularization (TLR) within 12 months.
Time frame: 12 months
Technical success, defined as the ability to achieve final residual angiographic stenosis no greater than 30%.
Time frame: procedural
Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without prior TLR are defined as being primary patent at the given follow-up.
Time frame: 1 & 24 months
Clinical success, defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification
Time frame: 1, 12 & 24 months
Serious adverse events
Time frame: up to 24 months
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Herzzentrum Leipzig
Leipzig, Saxony, Germany