Post-Market Clinical Follow-Up of S.M.A.R.T. Family of Stents in Treating Iliac and Femoropopliteal Artery Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCordis US Corp.
About this trial
The purpose of this study is to evaluate long-term safety and performance per the intended use of the S.M.A.R.T.™ Nitinol Stent System (SMART 120/150), S.M.A.R.T.™ CONTROL™ Nitinol Stent System (SMART CONTROL) and S.M.A.R.T.™ Flex Vascular Stent System (SMART Flex) in the treatment of iliac and femoropopliteal artery disease.
Eligibility criteria
Qualifiers
Subjects treated with SMART 120/150, SMART CONTROL or SMART Flex according to the respective Instructions for Use for treatment in the iliac, superficial femoral and/or proximal popliteal arteries.
If an EC-approved informed consent waiver is not obtained, then documented informed consent from the subject or legal representative granting permission to share the subject's clinical data It is recommended to include subjects with follow-up data available for a minimum of five (5) years from the date of treatment/procedure or until time of death, whichever came first.
Disqualifiers
Women who were pregnant or lactating at the time of the procedure.
Pediatric subjects (<18 years of age) at the time of the procedure.
Trial design
Treatments tested in this trial
- S.M.A.R.T.™ Nitinol Stent System (SMART 120/150)
- S.M.A.R.T.™ CONTROL ™ Nitinol Stent System
- S.M.A.R.T.™ Flex Vascular Stent System
Treatment groups
240 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Cordis US Corp.
Lead sponsor
Rede Optimus Hospitalar SA
Collaborator
Source ClinicalTrials.gov