An observational study in Aneurysm Abdominal, Peripheral Aneurysms and Arterial Disease Occlusive, sponsored by Perouse Medical. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2022-08-29.
Sponsored by Perouse Medical · Observational
The purpose of this PMCF study is to evaluate a minimum of 125 subjects in 1 or 2 sites in France at least 1-year follow-up after surgery until a maximum of 5 years in the indication of abdominal and peripheral arterial surgery not crossing the knee flexion crease.
the objectives of the evaluation will describe safety and performance of POLYMAILLE® EXTRA THIN.
960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.
This study's enrollment of 373 is above the median of 151 across 443 observational studies indexed under Aneurysm.
Browse Aneurysm studies →Perouse Medical is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient population conditions that may indicate abdominal and/or peripheral vascular open surgical repair with implantation of a POLYMAILLE EXTRA THIN vascular graft include:
Peripheral arterial diseases (PAD), characterized by reduced blood flow to the lower extremities, which may be categorized as:
Peripheral arterial aneurysms, characterized by a permanent localized (i.e., focal) modification of the parallelism of the vessel walls, which may be categorized by the following location:
Patient has a minimum of 1-year post-operative follow-up data available, or complete data to death
Exclusion Criteria:
POLYMAILLE® EXTRA THIN vascular prostheses are indicated for replacement or bypass of arteries presenting aneurysm or obliterative arterial disease. Their indication is restricted to abdominal and peripheral surgery not crossing the knee flexion crease. Abdominal vascular surgery includes aorto-iliac and/or aorto-femoral vascular repair, i.e. graft implantation with proximal anastomosis to abdominal aorta (supra and/or infra-renal). Peripheral vascular surgery includes peripheral arteries repair, i.e. graft implantation with no aortic anastomosis, and/or extra-anatomic vascular repair such as axillo-femoral and/or crossover bypass (femoro-femoral and/or ilio-femoral) and/or femoro-popliteal bypass above the knee.
Primary performance endpoint
primary patency rate
Time frame: 1 year
Primary safety endpoint
limb salvage rate
Time frame: 1 year
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
patent grafts without any procedure or intervention of the conduit itself
Time frame: 5 years
Primary assisted patency rate
rate of patent grafts, with or without procedure or intervention of the conduit itself after device implantation, such as endovascular balloon angioplasty or anastomotic revision, however with graft never thrombosed (graft occlusion)
Time frame: 5 years
-Secondary patency rate
rate of patent grafts, with or without procedure or intervention of the conduit itself after device implantation, such as endovascular balloon angioplasty or anastomotic revision, lysis and/or thrombectomy
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
freedom % from target limb major amputation
Time frame: 5 years
Adverse events
any documented adverse events, including anticipated (as listed in section 6.2) and non-anticipated adverse events
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Perouse Medical