Clinical trial NCT05622084: The Inperia Advance Post-Market Retrospective Study
Official title: Inperia Advance Carbostent™ for Infra-popliteal Artery Stenosis. Evaluation of Safety and Performance in Everyday Clinical Practice: The Inperia Advance Post-Market Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Arterial Disease
Lead sponsor: CID S.p.A.
Sponsor class: INDUSTRY
Collaborators: name: Meditrial Europe Ltd.
First posted: 2022-11-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: The Inperia Advance Carbostent™ 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.

Detailed description: 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 Carbostent™ is a CE-marked infra-popliteal stent for treatment of infra-popliteal artery stenosis.

Eligibility criteria: Inclusion Criteria:

* Patient has been implanted with at least one Inperia Advance device according to the indications described in the Instructions for Use (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

Primary outcomes:
measure: Rate of Major Adverse Events (MAE)
timeFrame: 12 months
Secondary outcomes:
measure: Primary patency
timeFrame: 6 months and 12 months
measure: Limb-salvage rate (LSR)
timeFrame: 6 months and 12 months
measure: Secondary patency
timeFrame: 6 months and 12 months or latest patency data available
measure: Death
timeFrame: 30 days
measure: Clinically driven Target Lesion Revascularization
timeFrame: 6 months and 12 months
measure: Target limb ischemia
timeFrame: 6 months and 12 months
measure: Rutherford category measurement
timeFrame: pretreatment, 6 months and 12 months
measure: Evaluation of Serious Adverse Events (SAEs)
timeFrame: 6 months and 12 months
measure: Acute success (device and procedural) within discharge
timeFrame: 24/72 hours
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: CHRU Strasbourg
Study officials:
References: