NCT01698671

Brief Summary

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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

Geographic Reach
2 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2012

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 3, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

November 26, 2013

Status Verified

November 1, 2013

Enrollment Period

1 year

First QC Date

October 1, 2012

Last Update Submit

November 24, 2013

Conditions

Aortic Aneurysm, AbdominalOcclusive Disease of Artery of Lower Extremity

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Mortality rate

    6 months

Study Arms (1)

InterGard Synergy Vascular Graft

OTHER
Device: InterGard Synergy Vascular Graft

Interventions

InterGard Synergy Vascular GraftDEVICE
InterGard Synergy Vascular Graft

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients requiring an InterGard Synergy Vascular Graft

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Study Centers

Graz, Vienna, Austria

Location

Study Centers

Frankfurt, Karlsruhe, Germany

Location

Study Centers

Heidelberg, Hamburg, Hanau, Germany

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • Max Zegelman, MD

    Krankenhaus Nordwest

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2012

First Posted

October 3, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Study Completion

May 1, 2014

Last Updated

November 26, 2013

Record last verified: 2013-11

Locations

AU(1)DE(2)