Comparison of stAndard and Hybrid Surgical Techniques in... | NCT03711136

Studies
Comparison of stAndard and Hybrid Surgical Techniques in the Treatment of proximaL Aortic dissEctions

NCT03711136

Sponsor

Novosibirsk Scientific Research Institute for Circulatory Pathology

Status

Completed

Last Update Posted

Oct 18, 2018Actual

Enrollment

100Actual

Phase

Not provided

Conditions

State of Non-operated Aortic Segments
Aorto-related Events

Interventions

aortic prosthesis

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

Oct 2018

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

Jan 1, 2018Actual

Primary Completion Date

May 1, 2018Actual

Completion Date

Aug 31, 2018Actual

First Submitted Date

Oct 15, 2018

First Submission Date that Met QC Criteria

Oct 15, 2018

First Posted Date

Oct 18, 2018Actual

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

Oct 15, 2018

Last Update Posted Date

Oct 18, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alexander Edemskiy, cardiovascular surgeon, Novosibirsk Scientific Research Institute for Circulatory PathologyPrincipal Investigator

Lead Sponsor

Novosibirsk Scientific Research Institute for Circulatory PathologyOTHER

Collaborators

Not provided

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

The study is devoted to the evaluation of the results of surgical treatment of patients with proximal aortic dissection. Two groups of patients with standard and hybrid surgery are compared. Early and long-term postoperative results are evaluated.

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Frozen elephant trunk surgery			Procedure: aortic prosthesis
Standart surgery			Procedure: aortic prosthesis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
aortic prosthesis	Procedure	ascending aortic and/or aortic arch prosthesis with linear vascular prosthesis or hybrid prosthesis	Frozen elephant trunk surgery Standart surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Aorto-related events	Death, reoperations,thoracoabdomminal aneurysms	3 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aortic dissection type A

Exclusion Criteria:

age limits

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patients with proximal aortic dissection operated using one of the techniques

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
NRICP		Novosibirsk		620055	Russia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided