Peripheral Arterial Occlusive Disease, Peripheral Artery Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEEasy Flype/EasyHiFlype
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.
Sponsors
Meditrial Europe Ltd.
CID S.p.A.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has been implanted with at least one study stent according to the indications described in the IFU * Study device implantation date is at least one year (12 months) prior to the starting date of the retrospective anonymous data collection
Exclusion criteria
* Patients treated less than 12 months prior to study start
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Major Adverse Events (MAE) | 12 months | Composite endpoint of all causes of death, unplanned target limb major amputation and/or clinically indicated target lesion revascularization (TLR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Limb-salvage rate (LSR) | 6 months and 12 months | 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 |
| Secondary patency | 6 months and 12 months or latest patency data available | Patency following successful target lesion revascularization (TLR) |
| Death | 30 days | Death within 30 days of the index procedure |
| Clinically driven Target Lesion Revascularization | 6 months and 12 months | Clinically driven Target Lesion Revascularization |
| Primary patency | 6 months and 12 months | 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) |
| Rutherford category measurement | pretreatment, 6 months and 12 months | Rutherford category measurement |
| Evaluation of Serious Adverse Events (SAEs) | 6 months and 12 months | Evaluation of Serious Adverse Events (SAEs) |
| Acute success (device and procedural) within discharge | 24/72 hours | 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 |
| Target limb ischemia | 6 months and 12 months | Target limb ischemia requiring surgical intervention or surgical repair of target vessel rate |
Countries
Italy
Contacts
Primary ContactFranco Vallana, MD
Backup ContactMonica Tocchi, MD
Outcome results
None listed