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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05516043
Other study ID # 2021-PT-01
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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