A Physician initiated PMCF Trial Investigating the BeSmooth Peripheral Stent System for the treatment of Iliac Lesions. The objective of this clinical investigation is to evaluate the long-term safety and efficacy of the BeSmooth Peripheral Stent System in clinical settings post CE-certification when used according to the indications of the IFU.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
patients treated with the BeSmooth Peripheral Stent System
OLV Hospital
Aalst, Belgium
Imelda Hospital Bonheiden
Bonheiden, Belgium
AZ Sint-Blasius
Dendermonde, Belgium
Heilig Hart Hospital
Tienen, Belgium
Primary Patency at 12 months
defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (\>50%, systolic velocity ratio no greater than 2.4) and without Target Lesion Revascularization (TLR) within 12 months.
Time frame: 12 months
Primary Patency at 1 & 6 month
Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (\>50%, systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent at the given follow-up.
Time frame: 1 and 6 months
Stent Occlusion Rate at 1,6 and 12-month follow-up
100% (re)occlusion rate within the study stent
Time frame: up to 12 months
ABI at 1,6 and 12-month follow-up, compared with baseline
Ankle-Brachial index measurements at 1,6 and 12-month FU visit, compared with measurements at baseline (pre operatively)
Time frame: up to 12 months
Amputation rate at 1,6 and 12-month follow-up
Amputation rate at 1-, 6- and 12-month follow-up, defined as any amputation above the knee.
Time frame: up to 12 months
Performance success rate at baseline, defined as restoration of blood flow
Device success, restoration of blood flow during index procedure
Time frame: during the index study procedure
In-stent restenosis rate
restenosis rate within the study stent
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Time frame: up to 12 months
Freedom from Target Lesion Revascularization
Freedom from Target Lesion Revascularization (TLR), 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: up to 12 months
Serious Adverse Events
Serious Adverse Events (SAEs), defined according to ISO 14155:2011 as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.
Time frame: up to 12 months
Technical success
The ability to achieve final residual angiographic stenosis no greater than 30%
Time frame: during the index study procedure
Clinical success at follow-up is defined as an improvement of Rutherford Classification at 1-,6- and 12-month follow-up
Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-, 6- and 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification
Time frame: up to 12 months