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| Name | Class |
|---|---|
| Meditrial Europe Ltd. | INDUSTRY |
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The Inperia Advance Carbostentâ„¢ is a CE-marked infra-popliteal stent for treatment of infra-popliteal artery stenosis. The aim of this post-market retrospective study protocl P32203 is to collect clinical data of patients treated with Inperia Advance for the treatment of infra-popliteal artery stenosis 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 the device 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 device Inperia Advance 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 Inperia Adavance. The Inperia Advance Carbostentâ„¢ is a CE-marked infra-popliteal stent for treatment of infra-popliteal artery stenosis.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inperia Advance | Device | Patients with infra-popliteal artery stenosis implanted with at least one Inperia Advance device |
| 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 implanted with at least one Inperia Advance stent for treatment of infra-popliteal artery stenosis, 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 |
|---|---|---|---|---|---|---|
| CHRU Strasbourg | Strasbourg | France |
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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 |
| 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 |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |