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

Aneurysm Abdominal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05519826
• Other study ID #: PMET-2022-01
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: April 20, 2022

Study information

• Verified date: August 2022
• Source: Perouse Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 373
• Est. completion date: April 20, 2022
• Est. primary completion date: April 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm Abdominal
• Aortic Aneurysm, Abdominal
• Arterial Occlusive Diseases
• Peripheral Aneurysms

Intervention

Device:
• Vascular surgery
POLYMAILLE® EXTRA THIN 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. Abdominal vascular surgery includes aorto-iliac and/or aorto-femoral vascular repair, i.e. graft implantation with proximal anastomosis to abdominal aorta (supra and/or infra-renal). Peripheral vascular surgery includes peripheral arteries repair, i.e. graft implantation with no aortic anastomosis, and/or extra-anatomic vascular repair such as axillo-femoral and/or crossover bypass (femoro-femoral and/or ilio-femoral) and/or femoro-popliteal bypass above the knee.

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Perouse Medical	ECLEVAR MEDTECH

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary performance endpoint	primary patency rate	1 year
Primary	Primary safety endpoint	limb salvage rate	1 year
Secondary	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
Secondary	Primary patency rate	patent grafts without any procedure or intervention of the conduit itself	5 years
Secondary	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	-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
Secondary	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
Secondary	Mortality rate	freedom % from death	5 years
Secondary	Limb salvage rate	freedom % from target limb major amputation	5 years
Secondary	Adverse events	any documented adverse events, including anticipated (as listed in section 6.2) and non-anticipated adverse events	5 years