Availability of Venous Conduits in Patients With Varicose... | NCT06332833

Studies
Availability of Venous Conduits in Patients With Varicose Veins for Arterial Bypass Surgery

NCT06332833

Sponsor

Pirogov Russian National Research Medical University

Status

Completed

Last Update Posted

Nov 7, 2024Actual

Enrollment

285Actual

Phase

Not provided

Conditions

Varicose Veins
Peripheral Arterial Disease

Interventions

Not provided

Countries

Russia

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

Dec 2023

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

Dec 1, 2023Actual

Primary Completion Date

May 31, 2024Actual

Completion Date

May 31, 2024Actual

First Submitted Date

Mar 15, 2024

First Submission Date that Met QC Criteria

Mar 22, 2024

First Posted Date

Mar 27, 2024Actual

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 5, 2024

Last Update Posted Date

Nov 7, 2024Actual

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

Detailed Description

Patients with PAD having superficial femoral artery (SFA) occlusion were consecutively enrolled. Demographic data and medical history were taken. Physical examination and duplex ultrasound were performed. The investigators registered presence of varicose veins, type of previous invasive procedure and availability of saphenous trunks as possible grafts

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

285Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
availability of saphenous trunks as possible grafts	availability of saphenous trunks as possible grafts (Yes\|No)	at the moment of inclusion

Secondary Outcomes

Measure	Description	Time Frame
presence of varicose veins	presence of varicose veins (Yes\|No)	at the moment of inclusion
type of previous invasive procedure	Phlebectomy\ radiofrequency ablation\ endovenous laser ablation (Yes\|No)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Older than 18 Years

Exclusion Criteria:

Those unwilling to sign an informed consent were also included.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with PAD having superficial femoral artery (SFA) occlusion.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Veronika Golovina		Moscow	Pirogov Russian National Research Medical University	109044	Russia

Condition Browse Module

MeSH Terms

ID	Term
D014648	Varicose Veins
D058729	Peripheral Arterial Disease

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D050197	Atherosclerosis
D001161	Arteriosclerosis

Browse Leaves

Not provided

Browse Branches

Not provided