Safety and Performance of POLYTHESE® Vascular Prosthesis | NCT05516043

Studies
Safety and Performance of POLYTHESE® Vascular Prosthesis

NCT05516043

Sponsor

Perouse Medical

Status

Completed

Last Update Posted

Aug 25, 2022Actual

Enrollment

256Actual

Phase

Not provided

Conditions

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

Interventions

Implantation with POLYTHESE®

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 7, 2021Actual

Primary Completion Date

Oct 21, 2021Actual

Completion Date

Nov 26, 2021Actual

First Submitted Date

Aug 23, 2022

First Submission Date that Met QC Criteria

Aug 23, 2022

First Posted Date

Aug 25, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2022

Last Update Posted Date

Aug 25, 2022Actual

Name	Class
Eclevar Medtech	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

256Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Implantation with POLYTHESE®	Procedure	thoracic vascular surgery, abdominal vascular surgery and peripheral vascular surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Performance: Primary patency rate	Patency rate	1 year
Safety : Mortality rate		30 days

Secondary Outcomes

Measure	Description	Time Frame
Procedural success rate	Ability to use with no need for replacement by another device and, Effective vascular flow restoration after procedure and, In case of aneurysm, exclusion of aneurysmal portion after procedure.	5 years
Primary patency rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients must meet the following inclusion criteria in order to be eligible for inclusion in the study:

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

Exclusion Criteria:

- none

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHU CAEN		Caen		14000	France
CHU de NANTES

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 1, 2021	Aug 23, 2022	Prot_000.pdf

Condition Browse Module

MeSH Terms

ID	Term
D058729	Peripheral Arterial Disease
D008382	Marfan Syndrome
D000094665	Dissection, Blood Vessel
D004535	Ehlers-Danlos Syndrome

Ancestor Terms

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004343	Drug Implants

Ancestor Terms

ID	Term
D003692	Delayed-Action Preparations
D004304	Dosage Forms
D004364	Pharmaceutical Preparations

Browse Leaves

Not provided

Browse Branches

Not provided