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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peripheral Arterial Occlusive Disease; Peripheral Artery Disease
• Intervention / Treatment: Device: Easy Flype/EasyHiFlype

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Franco Vallana, MD; Phone Number: +39 0161 18261; Email: franco.vallana@alvimedica.com

Study Locations

• Italy
  • Firenze, Italy
    • Ospedale S. Giovanni di Dio
    • Contact: Michelagnoli Stefano, MD; Email: stefano.michelagnoli@uslcentro.toscana.it
  • Treviso, Italy
    • Ospedale di Treviso
    • Contact: Fabrizio Farneti, MD; Email: fabrizio.farneti@aulss2:veneto.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 patency	Patency following successful target lesion revascularization (TLR)	6 months and 12 months or latest patency data available
Death	Death within 30 days of the index procedure	30 days
Clinically driven Target Lesion Revascularization	Clinically driven Target Lesion Revascularization	6 months and 12 months
Target limb ischemia	Target limb ischemia requiring surgical intervention or surgical repair of target vessel rate	6 months and 12 months
Rutherford category measurement	Rutherford category measurement	pretreatment, 6 months and 12 months
Evaluation of Serious Adverse Events (SAEs)	Evaluation of Serious Adverse Events (SAEs)	6 months and 12 months
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

Collaborators and Investigators

• Sponsor: CID S.p.A.
• Collaborators: Meditrial Europe Ltd.

Publications and helpful links

Helpful Links

• Manufactured website
• Clinical Research Organization

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease; Arterial Occlusive Diseases
• Other Study ID Numbers: P42201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No