Reverse-Loop Upper Arm Arteriovenous Graft | NCT00708825

Studies
Reverse-Loop Upper Arm Arteriovenous Graft

NCT00708825

Sponsor

Far Eastern Memorial Hospital

Status

Suspended

Last Update Posted

Jul 2, 2008Estimated

Enrollment

7Actual

Phase

Not provided

Conditions

Blood Vessel Prosthesis

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

Jun 2008

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Dec 2008Estimated

Completion Date

Dec 2008Estimated

First Submitted Date

Jun 30, 2008

First Submission Date that Met QC Criteria

Jun 30, 2008

First Posted Date

Jul 2, 2008Estimated

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

Jun 30, 2008

Last Update Posted Date

Jul 2, 2008Estimated

Name	Class
Min-Sheng General Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Background: A conventional configured prosthetic arteriovenous graft (AVG) usually wastes most upper arm vessels that a reverse-loop design may conserve. This study examined the feasibility of the AVG construction and its outcome.

Methods: Retrospective review of clinical outcomes of reverse-loop upper arm AVG patients. Measures included hemodialysis function, duplex scan, procedural complications, and follow-up interventions

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

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

7Actual

Label	Type	Description	Intervention Names
1		surgical outcome, observation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
functional event-free primary patency		event-free time

Secondary Outcomes

Measure	Description	Time Frame
Measures included hemodialysis function, duplex scan, procedural complications, and follow-up interventions.		events (month)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

compromized forearm and elbow options

Exclusion Criteria:

unstable

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

uremic patient, compromized forarm and elbow options

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chih-Yang Chan, MD, PhD	Far Eastern Memorial Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Far Eastern Memorial Hospital		Banqiao District	Taipei	220	Taiwan