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
This trial does not accept healthy volunteersQualifiers
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 population
Subjects to be included in this study are those treated with SMART 120/150, SMART CONTROL or SMART Flex, according to the respective Instructions for Use, for stenosis in the iliac, superficial femoral and/or proximal popliteal arteries. Approximately 20 sites located in approximately three (3) European countries with high volume use of one or more of the study products will participate.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
S.M.A.R.T.™ Nitinol Stent System (SMART 120/150)
DeviceThe Cordis S.M.A.R.T.™ Nitinol Stent System is intended to deliver a self-expanding endovascular stent to the peripheral vasculature via a sheathed delivery system. The stent component imparts an outward radial force on the luminal surface of the vessel wall restoring vascular patency. The S.M.A.R.T. ™ Nitinol Stent System is indicated in enabling treatment in patients with atherosclerotic disease of the superficial femoral artery and proximal popliteal artery.
S.M.A.R.T.™ CONTROL ™ Nitinol Stent System
DeviceThe Cordis S.M.A.R.T.™ CONTROL™ Nitinol Stent System is intended to deliver a self-expanding endovascular stent to the iliac and/or superficial femoral arteries via a sheathed delivery system. The stent component imparts an outward radial force on the luminal surface of the vessel wall restoring vascular patency. The S.M.A.R.T. ™ CONTROL™ Nitinol Stent System is indicated in enabling treatment in patients with atherosclerotic disease of iliac and/or superficial femoral arteries.
S.M.A.R.T.™ Flex Vascular Stent System
DeviceThe Cordis S.M.A.R.T.™ Flex Stent is a single-use device consisting of an endovascular stent and sheath delivery system, intended to deliver a self-expanding endovascular stent to the superficial femoral artery (SFA). The stent component imparts an outward radial force on the luminal surface of the vessel wall restoring vascular patency. The S.M.A.R.T.™ Flex Stent is indicated in enabling treatment of patients with symptomatic vascular stenotic and/or occlusive diseases in the superficial femoral artery and proximal popliteal artery.
Treatment groups
240 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Subjects with stenotic lesions of the superficial femoral artery (SFA) treated with SMART 120/150.1 intervention
Group B: Subjects with stenotic lesions of the proximal popliteal artery (PPA) treated with SMART 120/150.1 intervention
Group C: Subjects with stenotic lesions of the iliac artery treated with SMART CONTROL.1 intervention
Group D: Subjects with stenotic lesions of the superficial femoral artery (SFA) treated with SMART CONTROL.1 intervention
Group E: Subjects with stenotic lesions of the superficial femoral artery (SFA) treated with SMART Flex.1 intervention
Group F: Subjects with stenotic lesions of the proximal popliteal artery (PPA) treated with SMART Flex.1 intervention
Trial outcomes
Primary outcomes
1
Technical success of SMART 120/150 in patients with obstructive SFA disease
Technical success, defined as achievement of a final diameter stenosis of less than or equal to (≤) 30% residual stenosis at the conclusion of the index procedure
Time frame
At the conclusion of the index procedure2
Major amputation in patients treated with SMART 120/150 for obstructive SFA disease
Major amputation at 12 months post-index procedure
Time frame
At 12 months post-index procedure3
Technical success of SMART 120/150 in patients with obstructive PPA disease
Technical success, defined as achievement of a final diameter stenosis of less than or equal to (≤) 30% residual stenosis at the conclusion of the index procedure
Time frame
At the conclusion of the index procedure4
Major amputation in patients treated with SMART 120/150 for obstructive PPA disease
Major amputation at 12 months post-index procedure
Time frame
At 12 months post-index procedureSecondary outcomes
1
Patency at 12 months post-index procedure in patients treated with SMART 120/150 for obstructive SFA disease
Patency at 12 months post-index procedure, defined as achievement of less than or equal to (≤) 50% diameter stenosis
Time frame
At 12 months post-index procedure2
Patency at 12 months post-index procedure in patients treated with SMART 120/150 for obstructive PPA disease
Patency at 12 months post-index procedure, defined as achievement of less than or equal to (≤) 50% diameter stenosis
Time frame
At 12 months post-index procedure3
Patency at 12 months post-index procedure in patients treated with SMART CONTROL for obstructive iliac artery disease
Patency at 12 months post-index procedure, defined as achievement of less than or equal to (≤) 50% diameter stenosis
Time frame
At 12 months post-index procedure4
Patency at 12 months post-index procedure in patients treated with SMART CONTROL for obstructive SFA disease
Patency at 12 months post-index procedure, defined as achievement of less than or equal to (≤) 50% diameter stenosis
Time frame
At 12 months post-index procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Cordis US Corp.
Lead sponsor
Rede Optimus Hospitalar SA
Collaborator
Source ClinicalTrials.gov
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