The aim of the prospective, multicentre, single-arm study is to assess safety and efficacy of a drug eluting stent in Nitinol alloy (NiTiDES) in term of vessel patency and composite event-free survival rate up to two years follow-up in focal/medium length lesions in patients with ischemic obstruction of superficial femoral arteries or/and proximal popliteal arteries.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Polyclinique Les Fleurs
Ollioules, France
Centre Privé Claude Galien
Quincy-sous-Sénart, France
Clinique Pasteur
Toulouse, France
Universitäts-Herzzentrum Freiburg
Bad Krozingen, Germany
Event-free survival rate from Major Adverse Events
Freedom from Clinical Events Committee (CEC) adjudicated Major Adverse Event (death, target limb amputation, target limb ischemia requiring surgical intervention or surgical repair of target vessel or clinically-driven target lesion revascularization) or worsening of the Rutherford score by 2 classes, or to class 5 or 6.
Time frame: 12 months after procedure
Primary patency (absence of clinically-driven target lesion revascularization or binary restenosis)
Primary patency is defined as absence of clinically-driven target lesion revascularization or binary restenosis; binary restenosis is defined as a peak systolic velocity ratio (PSVR) \>2.4 (duplex evaluation)
Time frame: 12 months after procedure
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St. Gertrauden Krankenhaus GmbH
Berlin, Germany
Universitätsklinikum Leipzig
Leipzig, Germany
Regiomed GefäBzentrum Sonneberg
Sonneberg, Germany
Maria Cecilia Hospital
Cotignola, Ravenna, Italy
San Raffaele Hospital
Milan, Italy
IRCCS Policlinico San Matteo
Pavia, Italy