Evaluation of Mechanical Stapler for Aortic Anastomoses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
SVSE 2000 Ltd.

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 Phase
Aortic Aneurysm, Abdominal Leriche Syndrome Procedure: AAA or AF/IB (end-to-end) in patients with Leriche Syndrome Not Applicable

Study Type : Interventional  (Clinical Trial)
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
Study Completion Date : July 2006

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

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

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

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 identifier (NCT number): NCT00319475

Augusta Hospital
Duesseldorf, Germany, 40472
Sponsors and Collaborators
SVSE 2000 Ltd.
Principal Investigator: Ralf Kolvenbach, MD Augusta Hospital, Berlin 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:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Leriche Syndrome
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Arterial Occlusive Diseases