Safety and Performance of POLYTHESE® Vascular Prosthesis

NCT05516043 | Completed

• 1 other identifier: 2021-PT-01
• Study Type: observational
• Target: 256
• Locations: 1 country
• Sites: 3

Brief Summary

POLYTHESE® study is a retrospective, observational, multicentre, case series which examine short and long-term outcomes of using POLYTHESE®. This study will be done on Real World Data to describe the safety and performance of the device. PMCF Study.

Conditions

Aneurysm Arterial; Peripheral Arterial Disease; Marfan Syndrome; Arterial Dissections; Ehlers-Danlos Syndrome

Outcome Measures

Primary Outcomes (2)

• Performance: Primary patency rate

  Patency rate

  1 year

• Safety : 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

  5 years

• Device Failure

  5 years

Interventions

Implantation with POLYTHESE® PROCEDURE

thoracic vascular surgery, abdominal vascular surgery and peripheral vascular surgery

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

all potential subjects who are appropriate for study inclusion, i.e. subjects implanted with POLYTHESE® 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 POLYTHESE® implanted for at least one year and have not objected to the collect of their data will be included in the study.

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:

• \- none

Sponsors & Collaborators

• Perouse Medical: lead
• Eclevar Medtech: collaborator

Study Sites (3)

CHU CAEN

Caen, 14000, France

Location

CHU de NANTES

Nantes, 44000, France

Location

CHU La Pitié Salpétrière

Paris, 75014, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Marfan Syndrome; Dissection, Blood Vessel; Ehlers-Danlos Syndrome

Interventions

Drug Implants

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Aneurysm; Hemostatic Disorders; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Skin Diseases, Genetic; Collagen Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Design

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

Study Record Dates

• First Submitted: August 23, 2022
• First Posted: August 25, 2022
• Study Start: July 7, 2021
• Primary Completion: October 21, 2021
• Study Completion: November 26, 2021
• Last Updated: August 25, 2022

Record last verified: 2022-08

Locations

FR (3)