Feasibility and Outcomes of Repetitive Radial Approach | NCT02017054

Studies
Feasibility and Outcomes of Repetitive Radial Approach

NCT02017054

Sponsor

Sheba Medical Center

Status

Withdrawn

Last Update Posted

May 18, 2017Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Injury of Radial Artery

Interventions

Cath

Countries

Israel

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

May 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Dec 10, 2013

First Submission Date that Met QC Criteria

Dec 15, 2013

First Posted Date

Dec 20, 2013Estimated

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

May 17, 2017

Last Update Posted Date

May 18, 2017Actual

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

The purpose of this study is to assess the feasibility of performing repetitive coronary angiograms via the radial approach

Detailed Description

Assessing succes of radial access in patients with prior TRA procedures

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Month

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cath patients		Patients with previous cardiac cath via the radial access who are planned for additional radial access cardiac cath	Other: Cath

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cath	Other	No intervention - registry	Cath patients	No intervention - registry

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To assess patency of radial artery after repetitive radial artery access		1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with previous successful radial artery approach scheduled for elective transradial coronary angiography

Exclusion Criteria:

Lack of indication to perform radial approach Abnormal Barbeau test result (type C and D) Presence of radial artery occlusion Previous important trauma of the upper limbs Presence of fistula for renal dialysis Lymphoedema Acute myocardial infarction Refusal to sign the informed consent form

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with previous history of trans radial cardiac cath who are planned for additional trans radial cardiac cath

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amit Segev, MD	Sheba MC	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center		Ramat Gan			Israel