The Long-term Results of the No-touch Vein Graft to the L... | NCT02339857

Studies
The Long-term Results of the No-touch Vein Graft to the Left Anterior Descending Artery.

NCT02339857

Sponsor

Örebro County Council

Status

Completed

Last Update Posted

Jan 16, 2015Estimated

Enrollment

97Actual

Phase

Not provided

Conditions

Ischemic Heart Disease
Atherosclerosis

Interventions

No-touch harvesting technique

Countries

Not provided

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

Jan 2015

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

Nov 2011

Primary Completion Date

Jun 2013Actual

Completion Date

Not provided

First Submitted Date

Jan 12, 2015

First Submission Date that Met QC Criteria

Jan 15, 2015

First Posted Date

Jan 16, 2015Estimated

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

Jan 15, 2015

Last Update Posted Date

Jan 16, 2015Estimated

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 was to investigate whether the no-touch saphenous vein grafts that were used in coronary artery bypass surgery between 2003-2008 had a patency rate comparable to the left internal thoracic artery when the vein grafts were anatomised to the left anterior descending artery.

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

97Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No-touch vein grafts to LAD			Procedure: No-touch harvesting technique

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No-touch harvesting technique	Procedure	The saphenous vein is harvested with a pedicle of surrounding tissue.	No-touch vein grafts to LAD

Measure	Description	Time Frame
Total patency of the no-touch vein grafts.		Mean time 8 years.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Coronary artery bypass grafting performed at the Department of Cardiothoracic Surgery, Örebro Universtiy Hospital between 2003-2008.
Saphenous vein graft harvesting using the no-touch technique.
The saphenous vein anastomised to the left anterior descending artery.
Informed consent

Exclusion Criteria:

Allergy to contrast media.
Impaired renal function.
Inability to conduct the study according to protocol.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients that performed coronary artery bypass surgery between 2003-2008 and received a no-touch saphenous vein graft to the left anterior descending artery were included consecutively.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ninos Samano, MD	Faculty of Medicine and Health, Örebro University, Örebro, Sweden	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017202	Myocardial Ischemia
D050197	Atherosclerosis

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases
D001161	Arteriosclerosis

Browse Leaves

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Browse Branches

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