An observational study in Aneurysm Arterial, Peripheral Arterial Disease and Marfan Syndrome, sponsored by Perouse Medical. Completed at 3 sites in France. Per ClinicalTrials.gov, last updated 2022-08-25.
Sponsored by Perouse Medical · 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.
1,573 studies on the registry are indexed under Peripheral Arterial Disease; 284 are open to participants now.
This study's enrollment of 256 is above the median of 190 across 427 observational studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Perouse Medical is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
all potential subjects who are appropriate for study inclusion, i.e. subjects implanted with POLYTHESE® for at least one year, or with complete data to death. As the study explores real world data, there is no exclusion criteria for subjects and all subjects with POLYTHESE® implanted for at least one year and have not objected to the collect of their data will be included in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
thoracic vascular surgery, abdominal vascular surgery and peripheral vascular surgery
Performance: Primary patency rate
Patency rate
Time frame: 1 year
Safety : Mortality rate
Time frame: 30 days
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.
Time frame: 5 years
Primary patency rate
rate patency of the bypass graft without procedure or intervention of the conduit itself (except for occlusion)
Time frame: 5 years
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
Time frame: 5 years
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
Time frame: 5 years
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
Time frame: 5 years
Mortality rate
freedom % from death
Time frame: 5 years
Limb salvage rate
defined as freedom % from target limb amputation
Time frame: 5 years
Adverse events
any documented adverse events, including anticipated and non-anticipated adverse events
Time frame: 5 years
Documents are hosted by the registry — open the source record to download them.
Ran from Jul 2021 to primary completion in Oct 2021, 3 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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