A Retrospective, Observational Study to Collect Clinical Safety and Performance Data of POLYMAILLE® EXTRA THIN Vascular Prothesis

The purpose of this PMCF study is to evaluate a minimum of 125 subjects in 1 or 2 sites in France at least 1-year follow-up after surgery until a maximum of 5 years in the indication of abdominal and peripheral arterial surgery not crossing the knee flexion crease.

the objectives of the evaluation will describe safety and performance of POLYMAILLE® EXTRA THIN.

Study Overview

• Status: Completed
• Conditions: Aneurysm Abdominal; Peripheral Aneurysms; Arterial Disease Occlusive; Prothesis
• Intervention / Treatment: Device: Vascular surgery

• Study Type: Observational
• Enrollment (Actual): 373

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

Patient population conditions that may indicate abdominal and/or peripheral vascular open surgical repair with implantation of a POLYMAILLE EXTRA THIN vascular graft include:

• Peripheral arterial diseases (PAD), characterized by reduced blood flow to the lower extremities, which may be categorized as:

  • Intermittent claudication (IC)
  • Chronic limb-threatening ischemia (CLTI)
  • Acute limb ischemia (ALI)

• Peripheral arterial aneurysms, characterized by a permanent localized (i.e., focal) modification of the parallelism of the vessel walls, which may be categorized by the following location:

  • Iliac arterial aneurysms (IAA)
  • Femoral arterial aneurysms (FAA)
  • Popliteal arterial aneurysms (PAA)

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 refused the collection of their personal 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	limb salvage rate	1 year

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 patency rate	patent grafts without any procedure or intervention of the conduit itself	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
-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
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
Limb salvage rate	freedom % from target limb major amputation	5 years
Adverse events	any documented adverse events, including anticipated (as listed in section 6.2) 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): March 1, 2022
• Primary Completion (Actual): April 20, 2022
• Study Completion (Actual): April 20, 2022

Study Registration Dates

• First Submitted: August 26, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 26, 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; Arterial Occlusive Diseases; Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: PMET-2022-01

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