Demographic Differences in Patients With Abdominal Aortic... | NCT04935268

Studies
Demographic Differences in Patients With Abdominal Aortic Aneurysm and Surgical Features of Treatment

NCT04935268

Sponsor

Ryazan State Medical University

Status

Completed

Last Update Posted

Nov 18, 2023Actual

Enrollment

800Actual

Phase

Not provided

Conditions

Aortic Aneurysm, Abdominal

Interventions

Not provided

Countries

Germany

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

No data available

No data is available for this block.

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

May 1, 2021Actual

Primary Completion Date

Nov 1, 2023Actual

Completion Date

Nov 1, 2023Actual

First Submitted Date

Jun 15, 2021

First Submission Date that Met QC Criteria

Jun 15, 2021

First Posted Date

Jun 22, 2021Actual

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

Nov 15, 2023

Last Update Posted Date

Nov 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The study of demographics and risk factors for abdominal aortic aneurysms, allows to individualize treatment approaches.

Determining of the results of treatment of patients who requires a late open conversion after EVAR will allow to develop the surgical approach and the selection of the optimal type of surgical treatment.

Determination of genetic polymorphisms will reduce the number of postoperative complications by predicting of possible complications in the long term period.

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

Yes

Target Follow-Up Duration

60 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

800Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Survival	Mortality	1-60 Month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Infrarenal Aortic Aneurysm

Exclusion Criteria:

Other Aneurysms

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients wit infrarenal Aortic Aneurysms

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Igor A Suchkov, Prof	Ryazan State Medical University	Study Director
Egan Kalmykov, Dr	Clinic of Vascular Surgery, Frechen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Egan Kalmykov		Frechen	Please Select	50226	Germany

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

There is a plan to make IPD and related data dictionaries available.

Types

Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017544	Aortic Aneurysm, Abdominal

Ancestor Terms

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided