Comparison of the Effects of Open and Endovascular Aortic... | NCT02220283

Studies
Comparison of the Effects of Open and Endovascular Aortic Aneurysm Repair on Long-term Renal Function

NCT02220283

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Aug 19, 2014Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Long-term Renal Dysfunction

Interventions

Not provided

Countries

Taiwan

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 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Jun 2015Estimated

Completion Date

Jun 2015Estimated

First Submitted Date

Aug 18, 2014

First Submission Date that Met QC Criteria

Aug 18, 2014

First Posted Date

Aug 19, 2014Estimated

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 18, 2014

Last Update Posted Date

Aug 19, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Compare the renal complication of endovascular and open repair of acute aortic dissection by including patient treated at NTUH in 2010~2013.

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

500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Long-term change of renal function (eGFR) after operation of aortic aneurysm		30 days

Secondary Outcomes

Measure	Description	Time Frame
Survival after operation of aortic aneurysm		3 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Patient underwent endovascular and open repair of aortic aneurysm at NTUH in 2010~2013 Age > 20 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient underwent endovascular and open repair of aortic aneurysm at NTUH in 2010~2013

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chun-Fu Lai, DM	Contact	+886-2-23123456	63921	d95421011@ntu.edu.tw

Overall Officials

Name	Affiliation	Role
Chun-Fu Lai, MD		Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D058186	Acute Kidney Injury
D000784	Aortic Dissection

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided