Peripheral Arterial Disease Clinical Trial
Official title:
A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data of POLYTHESE® Vascular Prostheses
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 |
Verified date | August 2022 |
Source | Perouse Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHU CAEN | Caen | |
France | CHU de NANTES | Nantes | |
France | CHU La Pitié Salpétrière | PAris |
Lead Sponsor | Collaborator |
---|---|
Perouse Medical | ECLEVAR MEDTECH |
France,
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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