NCT00319475

Brief Summary

Demonstrate the safety and performance of the Aortic Stapler when used to attach a synthetic graft to an aorta in AAA and Leriche Syndrome patients

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2006

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2006

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

October 11, 2006

Status Verified

October 1, 2006

First QC Date

April 27, 2006

Last Update Submit

October 8, 2006

Conditions

Aortic Aneurysm, AbdominalLeriche Syndrome

Outcome Measures

Primary Outcomes (1)

  • Time to complete each stapled anastomosis.

Secondary Outcomes (4)

  • Post-operative follow up:

  • no leakage

  • no dilatation

  • no fistula or hematoma at the anastomotic sites

Interventions

AAA or AF/IB (end-to-end) in patients with Leriche SyndromePROCEDURE

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient age is between 21 to 85 years old.
  • Patient is diagnosed with Abdominal Aortic Aneurysm (AAA) or -aorto-Iliac/Femoral Occlusive Arterial Disease (Leriche' syndrome) by CT-Angio examination and/or angiography examination in patients with Leriche' syndrome.
  • Patient with an aneurysm at the neck of the proximal or distal site that is between 5 to 10 mm and with a diameter of 16-22 mm.
  • Patient is scheduled for AAA repair

You may not qualify if:

  • Pregnant women
  • Active malignancy
  • Ruptured aneurysm
  • Thoraco-AAA
  • Patient with at least one of the following unstable risk factors:
  • Renal disease (Cr \>2)
  • Ischemic heart disease (unstable Angina)
  • Obstructive Pulmonary Disease (contraindicated for open aortic surgery by respiratory function exam)
  • Severe CHF (EF \< 25%)
  • Patient with known allergy to metals or to the contrast media
  • Participation in current or recent (within 60 days prior to surgery) clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augusta Hospital

Düsseldorf, 40472, Germany

Location

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalLeriche Syndrome

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesArterial Occlusive Diseases

Study Officials

  • Ralf Kolvenbach, MD

    Augusta Hospital, Berlin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 27, 2006

First Posted

April 27, 2006

Study Start

February 1, 2006

Study Completion

July 1, 2006

Last Updated

October 11, 2006

Record last verified: 2006-10

Locations

DE(1)