InterGard Synergy Post-Marketing Surveillance Study | NCT01698671

Studies
InterGard Synergy Post-Marketing Surveillance Study

NCT01698671

Sponsor

Maquet Cardiovascular

Status

Unknown status

Last Update Posted

Nov 26, 2013Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Aortic Aneurysm, Abdominal
Occlusive Disease of Artery of Lower Extremity

Interventions

InterGard Synergy Vascular Graft

Countries

Austria
Germany

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

Nov 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Oct 2013Actual

Completion Date

May 2014Estimated

First Submitted Date

Oct 1, 2012

First Submission Date that Met QC Criteria

Oct 2, 2012

First Posted Date

Oct 3, 2012Estimated

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

Nov 24, 2013

Last Update Posted Date

Nov 26, 2013Estimated

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 the study is to assess the performance and safety of the InterGard Synergy vascular graft.

Detailed Description

Study of the device in patients with aneurysmal and occlusive disease of the abdominal aorta and peripheral arteries.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
InterGard Synergy Vascular Graft	Other		Device: InterGard Synergy Vascular Graft

Interventions

Name	Type	Description	Arm Group Labels	Other Names
InterGard Synergy Vascular Graft	Device		InterGard Synergy Vascular Graft

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Graft Patency and Complications	Patency will be assessed by color-coded duplex ultrasound up to 6 months post implantation. Complications including the occurrence of graft infections will be assessed up to post implantation.	6 months

Secondary Outcomes

Measure	Description	Time Frame
Mortality rate	Mortality rate will be assessed up to 6 months post implantation.	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients requiring an InterGard Synergy Vascular Graft

Exclusion Criteria:

Patients with contra-indications per InterGard Synergy Vascular Graft
Patients with current graft infection
Patients with a known allergy to collagen, triclosan or silver acetate
Patients who require urgent or emergent surgery

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Max Zegelman, MD	Krankenhaus Nordwest	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Study Centers		Graz, Vienna			Austria
Study Centers

Condition Browse Module

MeSH Terms

ID	Term
D017544	Aortic Aneurysm, Abdominal

Ancestor Terms

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided