The Easy Flype Carbostent™ is a CE-marked nitinol self-expanding stent for superficial femoral artery (SFA) and Easy HiFlype Carbostent™is a CE-marked nitinol self-expanding stent for iliac vessels. The aim of this post-market retrospective study protocl P42201 is to collect clinical data of patients treated with Easy Flype or Easy Hi Flype for the stenosis or occlusion of the iliac artery, femoral artery and first third of the popliteal artery in routine clinical practice. In order to obtain long-term follow-up data, the data collection will be limited to patients that have been treated with these devices at least 12 months prior to the study start.
The objective of this post-market study is to systematically collect retrospective clinical data on the implantable medical devices EasyFlype/EasyHiFlype in the daily clinical practice in an unselected population treated within the intended use. Data will be collected via medical chart review in anonymous form to assess the safety and efficacy of EasyFlype/EasyHiFlype. The Easy Flype Carbostent™ is a CE-marked nitinol self-expanding stent for superficial femoral artery (SFA) and Easy HiFlype Carbostent™is a CE-marked nitinol self-expanding stent for iliac vessels.
Study Type
OBSERVATIONAL
Enrollment
80
Patients with stenosis or occlusion of the iliac artery, femoral artery and first third of the popliteal artery, implanted with at least one study device, the Easy Flype or the Easy Hi Flype.
Ospedale S. Giovanni di Dio
Florence, Italy
Ospedale di Treviso
Treviso, Italy
Rate of Major Adverse Events (MAE)
Composite endpoint of all causes of death, unplanned target limb major amputation and/or clinically indicated target lesion revascularization (TLR)
Time frame: 12 months
Primary patency
Primary patency is defined as absence of clinically-driven target lesion revascularization or binary restenosis. Binary restenosis is defined as a peak systolic velocity ratio (PSVR) \>2.4 (Duplex Ultrasound evaluation)
Time frame: 6 months and 12 months
Limb-salvage rate (LSR)
Limb-salvage rate (LSR) is defined as rate of patients free from major amputation. Major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot
Time frame: 6 months and 12 months
Secondary patency
Patency following successful target lesion revascularization (TLR)
Time frame: 6 months and 12 months or latest patency data available
Death
Death within 30 days of the index procedure
Time frame: 30 days
Clinically driven Target Lesion Revascularization
Clinically driven Target Lesion Revascularization
Time frame: 6 months and 12 months
Target limb ischemia
Target limb ischemia requiring surgical intervention or surgical repair of target vessel rate
Time frame: 6 months and 12 months
Rutherford category measurement
Rutherford category measurement
Time frame: pretreatment, 6 months and 12 months
Evaluation of Serious Adverse Events (SAEs)
Evaluation of Serious Adverse Events (SAEs)
Time frame: 6 months and 12 months
Acute success (device and procedural) within discharge
Clinical device success defined as successful delivery and deployment of the stent(s) at the intended target lesion (this includes successful delivery and deployment of multiple stents) and final residual stenosis of the target lesion minor or equal to 30%, assessed by visual estimation and clinical device success without the occurrence of MAE during the hospital stay
Time frame: 24/72 hours
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