NCT03711136

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

October 15, 2018

Last Update Submit

October 15, 2018

Conditions

State of Non-operated Aortic SegmentsAorto-related Events

Outcome Measures

Primary Outcomes (1)

  • Aorto-related events

    Death, reoperations,thoracoabdomminal aneurysms

    3 years

Study Arms (2)

Frozen elephant trunk surgery

Procedure: aortic prosthesis

Standart surgery

Procedure: aortic prosthesis

Interventions

aortic prosthesisPROCEDURE

ascending aortic and/or aortic arch prosthesis with linear vascular prosthesis or hybrid prosthesis

Frozen elephant trunk surgeryStandart surgery

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with proximal aortic dissection operated using one of the techniques

You may qualify if:

  • aortic dissection type A

You may not qualify if:

  • age limits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NRICP

Novosibirsk, 620055, Russia

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
cardiovascular surgeon

Study Record Dates

First Submitted

October 15, 2018

First Posted

October 18, 2018

Study Start

January 1, 2018

Primary Completion

May 1, 2018

Study Completion

August 31, 2018

Last Updated

October 18, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)