Safety and Performance of POLYTHESE® Vascular Prosthesis

• Sponsor: Perouse Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05516043
• Collaborator: ECLEVAR MEDTECH (Other)
• Enrollment: 256
• Locations: 3
• Actual Duration (Months): 4.7
• Patients Per Site: 85.3
• Patients Per Site Per Month: 18.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Aneurysm Arterial; Peripheral Arterial Disease; Marfan Syndrome; Arterial Dissections; Ehlers-Danlos Syndrome	Procedure: Implantation with POLYTHESE®

Study Design

• Study Type: Observational
• Actual Enrollment: 256 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data of POLYTHESE® Vascular Prostheses
• Actual Study Start Date: Jul 7, 2021
• Actual Primary Completion Date: Oct 21, 2021
• Actual Study Completion Date: Nov 26, 2021

Outcome Measures

Primary Outcome Measures

1. Performance: Primary patency rate [1 year]

   Patency rate

2. Safety : Mortality rate [30 days]

Secondary Outcome Measures

1. Procedural success rate [5 years]

   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.

2. Primary patency rate [5 years]

   rate patency of the bypass graft without procedure or intervention of the conduit itself (except for occlusion)

3. Primary assisted patency rate [5 years]

   defined as rate patency of the bypass graft with or without procedure or intervention of the conduit itself (except for occlusion) after device implantation

4. Secondary patency [5 years]

   defined as rate patency of the bypass graft with or without procedure or intervention of the conduit itself for occlusion after device implantation

5. Device Failure [5 years]

   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

6. Mortality rate [5 years]

   freedom % from death

7. Limb salvage rate [5 years]

   defined as freedom % from target limb amputation

8. Adverse events [5 years]

   any documented adverse events, including anticipated and non-anticipated adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU CAEN	Caen		France	14000
2	CHU de NANTES	Nantes		France	44000
3	CHU La Pitié Salpétrière	PAris		France	75014

Sponsors and Collaborators

• Perouse Medical
• ECLEVAR MEDTECH

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jul 1, 2021

More Information

Publications

None provided.

• Responsible Party: Perouse Medical
• ClinicalTrials.gov Identifier: NCT05516043
• Other Study ID Numbers: 2021-PT-01
• First Posted: Aug 25, 2022
• Last Update Posted: Aug 25, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Marfan Syndrome; Arachnodactyly; Peripheral Arterial Disease; Peripheral Vascular Diseases; Ehlers-Danlos Syndrome; Syndrome

Study Results

No Results Posted as of Aug 25, 2022