The EasyFlype/EasyHiFlype Post Market Clinical Follow-up Study.

Peripheral Artery Disease Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05616169
• Other study ID #: P42201
• Status: Not yet recruiting
• Start date: February 2023
• Est. completion date: July 2023

Study information

• Verified date: November 2022
• Source: CID S.p.A.
• Contact: Franco Vallana, MD
• Phone: +39 0161 18261
• Email: franco.vallana[@]alvimedica.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: July 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Disease
• Peripheral Arterial Occlusive Disease
• Peripheral Artery Disease

Intervention

Device:
• Easy Flype/EasyHiFlype
Patients with stenosis or occlusion of the iliac artery, femoral artery and first third of the popliteal artery, implanted with at least one study device, the Easy Flype or the Easy Hi Flype.

Locations

Country	Name	City	State
Italy	Ospedale S. Giovanni di Dio	Firenze
Italy	Ospedale di Treviso	Treviso

Sponsors (2)

Lead Sponsor	Collaborator
CID S.p.A.	Meditrial Europe Ltd.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Major Adverse Events (MAE)	Composite endpoint of all causes of death, unplanned target limb major amputation and/or clinically indicated target lesion revascularization (TLR)	12 months
Secondary	Primary patency	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)	6 months and 12 months
Secondary	Limb-salvage rate (LSR)	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	6 months and 12 months
Secondary	Secondary patency	Patency following successful target lesion revascularization (TLR)	6 months and 12 months or latest patency data available
Secondary	Death	Death within 30 days of the index procedure	30 days
Secondary	Clinically driven Target Lesion Revascularization	Clinically driven Target Lesion Revascularization	6 months and 12 months
Secondary	Target limb ischemia	Target limb ischemia requiring surgical intervention or surgical repair of target vessel rate	6 months and 12 months
Secondary	Rutherford category measurement	Rutherford category measurement	pretreatment, 6 months and 12 months
Secondary	Evaluation of Serious Adverse Events (SAEs)	Evaluation of Serious Adverse Events (SAEs)	6 months and 12 months
Secondary	Acute success (device and procedural) within discharge	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	24/72 hours

External Links

•   Clinical Research Organization
•   Manufactured website