The objective of this clinical investigation is to demonstrate and provide long term clinical data on safety and performance of the Exist 6F NiTi stent system type FLEX \& PULL in a prospective investigation for the treatment of adult patients with de novo or re-stenotic symptomatic atherosclerotic lesions in Peripheral Artery Disease (PAD) requiring treatment of the Superficial Femoral Artery (SFA) or Proximal Popliteal Artery (P1 segment).
This is a multicenter, prospective study with clinical and radiographic follow-up for 24 months months post-procedure. Approximately two hundred thirty subjects will be enrolled (115 subjects will receive the FLEX type and 115 subjects the PULL type) in several centers, minimum 10 patients per investigational center. All patients will be evaluated at 30 days and 6-, 12- and 24-months post-index procedure.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
69
Subjects requiring treatment of the P1 segment of the proximal popliteal artery will be treated with the Exist 6F NiTi Stent FLEX type. Subjects requiring treatment of the SFA will undergo an additional calcification review based on the Fanelli classification. Subjects graded with Fanelli 1 or 2 will be treated with the Exist 6F NiTi Stent FLEX type.
Subjects requiring treatment of the SFA will undergo a calcification review based on the Fanelli classification. Subjects graded with Fanelli grade 3 and 4 will be treated with the Exist 6F NiTi Stent PULL type.
University Hospital of Catania
Catania, Sicily, Italy
University Clinical Hospital of Bialystok
Bialystok, Podlaskie Voivodeship, Poland
Primary patency
The primary patency rate (defined as freedom from more than ≥ 50% restenosis) at 12 months post-procedure as measured by Peak Systolic Velocity ratio (PSVr) assessed with Duplex ultrasound (DUS). A PSVr ≥ 2,5 suggests a reduction in the luminal diameter \>50%.
Time frame: 12 months
Major Adverse Events
Freedom from procedure- or stent-related Major Adverse Events (MAEs) at 30-days post index-procedure will be reported. MAE is defined as all causes of death and target limb major amputation, defined as amputation of the lower limb at the ankle level or above.
Time frame: 1 month
Improvement of Rutherford / Fontaine classification
Clinical success Defined as improvement of Rutherford / Fontaine classification of one class or more as compared to the pre-procedure and an ankle-brachial index improvement (ABI) by ≥ 0.15.
Time frame: 6- and 12-months
Primary patency
Compare the Exist 6F NiTi stent primary patency with \>50% of subjects with peripheral artery disease with literature data.
Time frame: 12-months
Rate of stent fracture
Stent fracture rate is evaluated with x-ray. Stent fracture is defined according to classification on x-ray.
Time frame: 12- and 24-months
Freedom from Target Lesion Revascularization
Defined as the absence of revascularization (by any means) of the target lesion (fTLR).
Time frame: 1 month, 6-, 12- and 24-months
Walking and mobility
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Improvement of walking and mobility is assessed by change in the 36-Item Short Form Survey (SF-36) score from baseline.
Time frame: 1 month, 6-, 12- and 24-months
Patency rate
Patency rate as measured by Peak Systolic Velocity ratio (PSVr) assessed with Duplex ultrasound (DUS). A PSVr ≥ 2,5 suggests a reduction in the luminal diameter \>50%.
Time frame: 24 months
Major Adverse Events
Procedure- or stent-related Major Adverse Events (MAEs) post index-procedure will be reported. MAE is defined as all causes of death and target limb major amputation, defined as amputation of the lower limb at the ankle level or above.
Time frame: 24 months