A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data on POLYMAILLE®C

NCT05517876 | Completed

• 1 other identifier: 2020-PMC-01
• Study Type: observational
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of the study is to describe safety and performance of POLYMAILLE® C from a minimum of 200 subjects will be evaluated. A minimum of 100 subjects will be evaluated for each main location of surgery (abdominal and peripheral). Follow-up At least 1 year follow-up after surgery until a maximum of 5 years. POLYMAILLE®C 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.

Conditions

Abdominal Vascular Surgery; Peripheral Vascular Surgery; Vascular Prothesis; Aneurysm Abdominal; Aneurysm; Peripheral; Obliterative Arterail Disease

Outcome Measures

Primary Outcomes (2)

• Primary performance endpoint

  primary patency rate

  1 year

• Primary safety endpoint

  mortality rate

  30 days

Secondary Outcomes (8)

• Procedural success rate

  5 years

• Primary patency rate

  5 years

• Primary assisted patency rate

  5 years

• Secondary patency rate

  5 years

• Device Failure

  5 years

Interventions

Vascular abdominal or peripheral surgery DEVICE

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 abdominal aorto-aortic and/or 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).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All potential subjects and will select those who are appropriate for study inclusion, i.e. subjects implanted with POLYMAILLE® C 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 POLYMAILLE® C implanted for at least one year and up to 5 years will be included in the study. All data will be retrieved from medical charts for each patient from time of surgery (considered as index date) until a maximum of 5 years after surgery. A minimum of 100 subjects will be evaluated for each main location of surgery (peripheral and abdominal).

You may not qualify if:

• Patients who have objected to the collect of their data.

Sponsors & Collaborators

• Perouse Medical: lead
• Eclevar Medtech: collaborator

Study Sites (1)

CHU de Nantes'

Nantes, 44093, France

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Aneurysm

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

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

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: July 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: August 26, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)