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| Name | Class |
|---|---|
| Meditrial Europe Ltd. | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Easy Flype/EasyHiFlype | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 6 months and 12 months |
| Limb-salvage rate (LSR) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients affected by stenosis or occlusion of the iliac artery, femoral artery and first third of the popliteal artery, implanted with at least one study device at least 12 months prior to the start date of the retrospective data collection.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Franco Vallana, MD | Contact | +39 0161 18261 | franco.vallana@alvimedica.com | |
| Monica Tocchi, MD | Contact | m.tocchi@meditrial.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale S. Giovanni di Dio | Florence | Italy |
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| Label | URL |
|---|---|
| Manufactured website | View source |
| Clinical Research Organization | View source |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| C564658 | Peripheral Arterial Occlusive Disease 1 |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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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 |
| 6 months and 12 months |
| Secondary patency | Patency following successful target lesion revascularization (TLR) | 6 months and 12 months or latest patency data available |
| Death | Death within 30 days of the index procedure | 30 days |
| Clinically driven Target Lesion Revascularization | Clinically driven Target Lesion Revascularization | 6 months and 12 months |
| Target limb ischemia | Target limb ischemia requiring surgical intervention or surgical repair of target vessel rate | 6 months and 12 months |
| Rutherford category measurement | Rutherford category measurement | pretreatment, 6 months and 12 months |
| Evaluation of Serious Adverse Events (SAEs) | Evaluation of Serious Adverse Events (SAEs) | 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 | 24/72 hours |
| Ospedale di Treviso | Treviso | Italy |
|
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |