The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term (up to 12 months) safety and efficacy of the Solaris Vascular Stent Graft (Scitech) in clinical settings when used according to the indications of the IFU.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Solaris Vascular Stent Graft for treatment of Iliac Lesions
Hospital Hochsauerland
Arnsberg, Germany
Saarland University Medical Center
Homburg, Germany
University Hospital Leipzig
Leipzig, Germany
St. Franziskus Hospital
Münster, Germany
Primary Patency Rate at 12 month follow-up
Time frame: 12 months post-op
Primary Patency Rate at 1- and 6 month follow-up
Time frame: 1 monthand 6 months post-op
Stent Graft Occlusion Rate at pre-discharge, 1-, 6-, and 12-month follow-up
Time frame: 1day, 1 month, 6 month and 12 month post-op
Ankle-Brachial Index at 1-, 6- and 12-month follow-up compared with baseline ABI
Time frame: 1-, 6- and 12-month post-op
Amputation rate at 1-, 6- and 12-month follow-up, defined as any amputation above the knee
Time frame: 1-, 6- and 12-month post-op
Performance success rate at baseline
defined as a composite of (a) successful in sealing acute perforation or rupture; (b) successful in treating aneurysm and fistulae ; (c) restoration of blood flow
Time frame: during procedure
in-stent restenosis rate at 1-, 6- and 12-month post-op
Time frame: 1-, 6-, 12-month post-op
Freedom from Target Lesion Revascularization at 1-, 6- and 12-month post-op
defined as freedom from a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge
Time frame: 1-, 6- and 12-month post-op
Serious Adverse Events (SAE's) until 12-month post-op
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University Hospital Münster
Münster, Germany
Hospital Oldenburg
Oldenburg, Germany
Azienda Ospedaliera di Perugia
Perugia, Italy
Fondazione Policlinico Gemelli
Rome, Italy
MCL Leeuwarden
Leeuwarden, Netherlands
St. Antonius Hospital
Nieuwegein, Netherlands
Time frame: within 12-months post-op
Technical success rate
defined as the ability to achieve final residual angiographic stenosis no greater than 30%
Time frame: during procedure
Clinical success at follow-up
defined as an improvement of Rutheford Classification at 1-, 6- and 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification
Time frame: 1-, 6- and 12-month post-op