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Evaluation of Mechanical Stapler for Aortic Anastomoses

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ClinicalTrials.gov Identifier: NCT00319475
Recruitment Status : Unknown
Verified October 2006 by SVSE 2000 Ltd..
Recruitment status was:  Active, not recruiting
First Posted : April 27, 2006
Last Update Posted : October 11, 2006
Sponsor:
Information provided by:

Study Description
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

Condition or disease Intervention/treatment
Aortic Aneurysm, Abdominal Leriche Syndrome Procedure: AAA or AF/IB (end-to-end) in patients with Leriche Syndrome

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Mechanical Stapler for Aortic Anastomoses
Study Start Date : February 2006
Estimated Study Completion Date : July 2006
Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. Time to complete each stapled anastomosis.

Secondary Outcome Measures :
  1. Post-operative follow up:
  2. no leakage
  3. no dilatation
  4. no fistula or hematoma at the anastomotic sites

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00319475


Locations
Germany
Augusta Hospital
Duesseldorf, Germany, 40472
Sponsors and Collaborators
SVSE 2000 Ltd.
Investigators
Principal Investigator: Ralf Kolvenbach, MD Augusta Hospital, Berlin
More Information

ClinicalTrials.gov Identifier: NCT00319475     History of Changes
Other Study ID Numbers: EU-DE 006
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: October 11, 2006
Last Verified: October 2006

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Leriche Syndrome
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Arterial Occlusive Diseases