Clinical trial NCT05616169: The EasyFlype/EasyHiFlype Post Market Clinical Follow-up Study.
Official title: Self-expanding Stent for the Treatment of Peripheral Artery Disease: Evaluation of Safety and Performance in Everyday Clinical Practice. The EasyFlype/EasyHiFlype Post Market Clinical Follow-up Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Artery Disease
Peripheral Arterial Occlusive Disease
Lead sponsor: CID S.p.A.
Sponsor class: INDUSTRY
Collaborators: name: Meditrial Europe Ltd.
First posted: 2022-11-15
Enrollment: 80
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 affected by stenosis or occlusion of the iliac artery, femoral artery and first third of the popliteal artery, implanted with at least one study device at least 12 months prior to the start date of the retrospective data collection.

Brief summary: The Easy Flype Carbostent™ is a CE-marked nitinol self-expanding stent for superficial femoral artery (SFA) and Easy HiFlype Carbostent™is a CE-marked nitinol self-expanding stent for iliac vessels.

The aim of this post-market retrospective study protocl P42201 is to collect clinical data of patients treated with Easy Flype or Easy Hi Flype for the stenosis or occlusion of the iliac artery, femoral artery and first third of the popliteal artery 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 these devices 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 devices EasyFlype/EasyHiFlype 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 EasyFlype/EasyHiFlype.

The Easy Flype Carbostent™ is a CE-marked nitinol self-expanding stent for superficial femoral artery (SFA) and Easy HiFlype Carbostent™is a CE-marked nitinol self-expanding stent for iliac vessels.

Eligibility criteria: Inclusion Criteria:

* Patient has been implanted with at least one study stent according to the indications described in the 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: Firenze
country: Italy
facility: Ospedale S. Giovanni di Dio
city: Treviso
country: Italy
facility: Ospedale di Treviso
Study officials:
References: