A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data on POLYMAILLE®C

Purpose of the study is to describe safety and performance of POLYMAILLE® C from a minimum of 200 subjects will be evaluated. A minimum of 100 subjects will be evaluated for each main location of surgery (abdominal and peripheral).

Follow-up At least 1 year follow-up after surgery until a maximum of 5 years. POLYMAILLE®C vascular prostheses are indicated for replacement or bypass of arteries presenting aneurysm or obliterative arterial disease. Their indication is restricted to abdominal and peripheral surgery not crossing the knee flexion crease.

Study Overview

• Status: Completed
• Conditions: Aneurysm Abdominal; Abdominal Vascular Surgery; Peripheral Vascular Surgery; Vascular Prothesis; Aneurysm; Peripheral; Obliterative Arterail Disease
• Intervention / Treatment: Device: Vascular abdominal or peripheral surgery

• Study Type: Observational
• Enrollment (Actual): 212

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • CHU de Nantes'

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All potential subjects and will select those who are appropriate for study inclusion, i.e. subjects implanted with POLYMAILLE® C for at least one year, or with complete data to death. As the study explores real world data, there is no exclusion criteria for subjects and all subjects with POLYMAILLE® C implanted for at least one year and up to 5 years will be included in the study.

All data will be retrieved from medical charts for each patient from time of surgery (considered as index date) until a maximum of 5 years after surgery.

A minimum of 100 subjects will be evaluated for each main location of surgery (peripheral and abdominal).

Description

Inclusion Criteria:

• Patients must meet all the following inclusion criteria in order to be eligible for inclusion in the study: Patient has a minimum of 1-year post-operative follow-up data available, or complete data to death

Exclusion Criteria:

• Patients who have objected to the collect of their data.

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
Primary performance endpoint	primary patency rate	1 year
Primary safety endpoint	mortality rate	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural success rate	Ability to use with no need for replacement by another device and,; Effective vascular flow restoration after procedure and,; In case of aneurysm, exclusion of aneurysmal portion after procedure.	5 years
Primary assisted patency rate	rate of patent grafts, with or without procedure or intervention of the conduit itself after device implantation, such as endovascular balloon angioplasty or anastomotic revision, however with graft never thrombosed (graft occlusion)	5 years
Device Failure	Uncontrolled blood leakage from device; Loss of structural integrity, e.g. rupture and/or exaggerated dilation (> 50 %); Occlusion of the device; Total or partial replacement of the device required	5 years
Mortality rate	freedom % from death	5 years
Primary patency rate	rate of patent grafts without any procedure or intervention of the conduit itself	5 years
Secondary patency rate	rate of patent grafts, with or without procedure or intervention of the conduit itself after device implantation, such as endovascular balloon angioplasty or anastomotic revision, lysis and/or thrombectomy.	5 years
Limb salvage rate	freedom % from target limb amputation	5 years
Adverse events	any documented adverse events, including anticipated and non-anticipated adverse events	5 years

Collaborators and Investigators

• Sponsor: Perouse Medical
• Collaborators: Eclevar Medtech

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aortic Aneurysm; Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 2020-PMC-01

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