Safety and Performance of POLYTHESE® Vascular Prosthesis

Peripheral Arterial Disease Clinical Trial

Official title:

A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data of POLYTHESE® Vascular Prostheses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05516043
• Other study ID #: 2021-PT-01
• Status: Completed
• Start date: July 7, 2021
• Est. completion date: November 26, 2021

Study information

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

Clinical Trial Summary

POLYTHESE® study is a retrospective, observational, multicentre, case series which examine short and long-term outcomes of using POLYTHESE®. This study will be done on Real World Data to describe the safety and performance of the device.

PMCF Study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: November 26, 2021
• Est. primary completion date: October 21, 2021
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients must meet 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:

• none

Related Conditions & MeSH terms

• Ehlers-Danlos Syndrome
• Marfan Syndrome
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Syndrome

Intervention

Procedure:
• Implantation with POLYTHESE®
thoracic vascular surgery, abdominal vascular surgery and peripheral vascular surgery

Locations

Country	Name	City	State
France	CHU CAEN	Caen
France	CHU de NANTES	Nantes
France	CHU La Pitié Salpétrière	PAris

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	Performance: Primary patency rate	Patency rate	1 year
Primary	Safety : Mortality rate		30 days
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	rate patency of the bypass graft without procedure or intervention of the conduit itself (except for occlusion)	5 years
Secondary	Primary assisted patency rate	defined as rate patency of the bypass graft with or without procedure or intervention of the conduit itself (except for occlusion) after device implantation	5 years
Secondary	Secondary patency	defined as rate patency of the bypass graft with or without procedure or intervention of the conduit itself for occlusion after device implantation	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	defined as freedom % from target limb amputation	5 years
Secondary	Adverse events	any documented adverse events, including anticipated and non-anticipated adverse events	5 years