The Inperia Advance Post-Market Retrospective Study

Not yet recruiting

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT05622084
• Lead Sponsor: CID S.p.A.

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.

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-11
• Study First Submitted QC: 2022-11-11
• Last Update Submitted: 2022-11-11
• Study First Posted: 2022-11-18
• Last Update Posted: 2022-11-18
• Study Start: 2023-02
• Primary Completion: 2023-06
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of Major Adverse Events (MAE)	12 months	Composite endpoint of all causes of death, unplanned target limb major amputation and/or clinically indicated target lesion revascularization (TLR)

Secondary Outcome Measures

Name	Time	Method
Primary patency	6 months and 12 months	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)
Secondary patency	6 months and 12 months or latest patency data available	Patency following successful target lesion revascularization (TLR)
Target limb ischemia	6 months and 12 months	Target limb ischemia requiring surgical intervention or surgical repair of target vessel rate
Acute success (device and procedural) within discharge	24/72 hours	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
Limb-salvage rate (LSR)	6 months and 12 months	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
Clinically driven Target Lesion Revascularization	6 months and 12 months	Clinically driven Target Lesion Revascularization
Rutherford category measurement	pretreatment, 6 months and 12 months	Rutherford category measurement
Evaluation of Serious Adverse Events (SAEs)	6 months and 12 months	Evaluation of Serious Adverse Events (SAEs)
Death	30 days	Death within 30 days of the index procedure

Trial Locations

Locations (1)

CHRU Strasbourg; 🇫🇷 Strasbourg, France