NCT05622084

The Inperia Advance Post-Market Retrospective Study

Inperia Advance Carbostent™ for Infra-popliteal Artery Stenosis. Evaluation of Safety and Performance in Everyday Clinical Practice: The Inperia Advance Post-Market Retrospective Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: CID S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Inperia Advance	Patients with infra-popliteal artery stenosis implanted with at least one Inperia Advance device

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-06-01
• Completion: 2023-07-01
• First posted: 2022-11-18
• Last updated: 2022-11-18

Locations

1 site across 1 country: France