The Inperia Advance Post-Market Retrospective Study

CID S.p.A.

Status: Not yet enrolling

Conditions: Peripheral Arterial Disease

Treatments: Device: Inperia Advance

Study type: Observational

Funder types: Industry

Identifiers

NCT05622084

P32203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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