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

NCT05616169 | Unknown

• 1 other identifier: P42201
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Peripheral Artery Disease; Peripheral Arterial Occlusive Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Primary patency

  6 months and 12 months

• Limb-salvage rate (LSR)

  6 months and 12 months

• Secondary patency

  6 months and 12 months or latest patency data available

• Death

  30 days

• Clinically driven Target Lesion Revascularization

  6 months and 12 months

Interventions

Easy Flype/EasyHiFlype DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients treated less than 12 months prior to study start

Sponsors & Collaborators

• CID S.p.A.: lead
• Meditrial Europe Ltd.: collaborator

Study Sites (2)

Ospedale S. Giovanni di Dio

Florence, Italy

Location

Ospedale di Treviso

Treviso, Italy

Location

Related Links

• Manufactured website
• Clinical Research Organization

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Arterial Occlusive Disease 1

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

Franco Vallana, MD

CONTACT

+39 0161 18261; franco.vallana@alvimedica.com

Monica Tocchi, MD

CONTACT

m.tocchi@meditrial.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 15, 2022
• Study Start: February 1, 2023
• Primary Completion: June 1, 2023
• Study Completion: July 1, 2023
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)