NCT04643743

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2022

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

1.8 years

First QC Date

November 1, 2020

Last Update Submit

August 19, 2022

Conditions

Artery Stenosis, CarotidArtery StenosisOcclusion of ArteryStroke

Keywords

vascular patchPolypatchfemoral endarterectomycarotid endarterectomyThrombosis

Outcome Measures

Primary Outcomes (1)

  • Change rate of restenosis

    Measure assessing change target-artery restenosis (defined as 70% or more diameter-reducing stenosis), occlusion, or re-intervention within 1 year after surgery using POLYPATCH®

    within 30 days after surgery and long term (up to 1 year after surgery )

Secondary Outcomes (9)

  • Procedural success rate

    within 30 days after surgery and long term (up to 1 year after surgery )

  • target-artery restenosis Target-artery restenosis

    within 30 days after surgery and long term (up to 3 years)

  • target-artery re-intervention

    within 30 days after surgery and long term (up to 3 years)

  • stroke (ipsilateral and any)

    within 30 days after surgery and long term (up to 3 years)

  • transient ischemic attack

    3 years

  • +4 more secondary outcomes

Study Arms (1)

Subjects who did receive POLYPATCH® for vascular angioplasty

Subjects who did receive POLYPATCH® at least one year ago for vascular angioplasty. 2 main sub-populations will be studied depending on location of surgery (carotid and femoral) but data will be collected for all subjects who did receive POLYPATCH.

Device: Endarterectomy

Interventions

EndarterectomyDEVICE

Endarterectomy is a surgical procedure to remove the atheromatous plaque material, or blockage, in the lining of an artery constricted by the buildup of deposits. It is carried out by separating the plaque from the arterial wall.

Also known as: Carotid Endarterectomy, Femoral Endarterectomy, Patch Angioplasty
Subjects who did receive POLYPATCH® for vascular angioplasty

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eclevar Medtech

Paris, 75017, France

Location

MeSH Terms

Conditions

Carotid StenosisArterial Occlusive DiseasesStrokeThrombosis

Interventions

EndarterectomyEndarterectomy, Carotid

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesEmbolism and Thrombosis

Intervention Hierarchy (Ancestors)

Vascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Armel Plaine, Master

    Eclevar Medtech

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2020

First Posted

November 25, 2020

Study Start

September 1, 2020

Primary Completion

June 10, 2022

Study Completion

June 10, 2022

Last Updated

August 24, 2022

Record last verified: 2022-08

Locations

FR(1)