Clinical trial NCT04643743: A Retrospective, Observational, Multicentre, Study to Evaluate the Safety and Performance of POLYPATCH ® Vascular Patch
Official title: A Retrospective, Observational, Multicentre, Study to Evaluate the Safety and Performance of POLYPATCH ® Vascular Patch
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Artery Stenosis, Carotid
Artery Stenosis
Occlusion of Artery
Stroke
Keywords: vascular patch
Polypatch
femoral endarterectomy
carotid endarterectomy
Thrombosis
Lead sponsor: Perouse Medical
Sponsor class: INDUSTRY
Collaborators: name: Eclevar Medtech
First posted: 2020-11-25
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators will screen all potential subjects and will select those who are appropriate for study inclusion, i.e. adult subjects implanted with POLYPATCH® for at least one year.

All data will be retrieved from medical charts for each patient from time of surgery (considered as baseline of study) until a maximum of 3 years after surgery.

A minimum of 250 up to a maximum of 300 subjects will be evaluated from 3 to 8 different sites. At least 100 subjects will be evaluated in carotid location and at least 100 in femoral location.

Brief summary: POLYPATCH® study is RWE multicentre study which examine short and long-term outcomes of using POLYPATCH® when exposed to a larger and more varied population.

All data will be retrieved from medical charts for each patient from time of surgery (considered as baseline of study) until a maximum of 3 years after surgery.

A minimum of 250 up to a maximum of 300 subjects will be evaluated from 3 to 8 different sites. At least 100 subjects will be evaluated in carotid location and at least 100 in femoral location.


Eligibility criteria: Inclusion Criteria:

* Subjects who did receive POLYPATCH® at least one year ago for vascular angioplasty
* Subjects ≥ 18 years old

Exclusion Criteria:

* None

Primary outcomes:
measure: Change rate of restenosis
timeFrame: within 30 days after surgery and long term (up to 1 year after surgery )
Secondary outcomes:
measure: Procedural success rate
timeFrame: within 30 days after surgery and long term (up to 1 year after surgery )
measure: target-artery restenosis Target-artery restenosis
timeFrame: within 30 days after surgery and long term (up to 3 years)
measure: target-artery re-intervention
timeFrame: within 30 days after surgery and long term (up to 3 years)
measure: stroke (ipsilateral and any)
timeFrame: within 30 days after surgery and long term (up to 3 years)
measure: transient ischemic attack
timeFrame: 3 years
measure: myocardial infarction
timeFrame: 3 years
measure: mortality (cardiovascular and all causes)
timeFrame: within 30 days after surgery and long term (up to 3 years)
measure: occurrence of other complications
timeFrame: within 30 days after surgery and long term (up to 3 years)
measure: Operation time
timeFrame: up to 24 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Eclevar Medtech
Study officials:
affiliation: Eclevar Medtech
name: Armel Plaine, Master
role: STUDY_DIRECTOR
References: