A Retrospective, Observational Study to Collect Clinical Safety and Performance Data of POLYMAILLE® EXTRA THIN Vascular Prothesis

NCT05519826 | Completed

• 1 other identifier: PMET-2022-01
• Study Type: observational
• Target: 373
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aneurysm Abdominal; Peripheral Aneurysms; Arterial Disease Occlusive; Prothesis

Outcome Measures

Primary Outcomes (2)

• Primary performance endpoint

  primary patency rate

  1 year

• Primary safety endpoint

  limb salvage rate

  1 year

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 surgery DEVICE

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.

Eligibility Criteria

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

Study Population

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: * Intermittent claudication (IC) * Chronic limb-threatening ischemia (CLTI) * Acute limb ischemia (ALI) * 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: * Iliac arterial aneurysms (IAA) * Femoral arterial aneurysms (FAA) * Popliteal arterial aneurysms (PAA)

You may qualify if:

• Patient has a minimum of 1-year post-operative follow-up data available, or complete data to death

You may not qualify if:

• Patients who refused the collection of their personal 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; Arterial Occlusive Diseases

Interventions

Vascular Surgical Procedures

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical Procedures; Surgical Procedures, Operative

Study Design

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

Study Record Dates

• First Submitted: August 26, 2022
• First Posted: August 29, 2022
• Study Start: March 1, 2022
• Primary Completion: April 20, 2022
• Study Completion: April 20, 2022
• Last Updated: August 29, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)