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Evaluation of Mechanical Stapler for Aortic Anastomoses

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2006 by SVSE 2000 Ltd..
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by:
SVSE 2000 Ltd.
ClinicalTrials.gov Identifier:
NCT00319475
First received: April 27, 2006
Last updated: October 8, 2006
Last verified: October 2006
  Purpose
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 Intervention
Aortic Aneurysm, Abdominal
Leriche Syndrome
Procedure: AAA or AF/IB (end-to-end) in patients with Leriche Syndrome

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Mechanical Stapler for Aortic Anastomoses

Further study details as provided by SVSE 2000 Ltd.:

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

Secondary Outcome Measures:
  • Post-operative follow up:
  • no leakage
  • no dilatation
  • no fistula or hematoma at the anastomotic sites

Estimated Enrollment: 10
Study Start Date: February 2006
Estimated Study Completion Date: July 2006
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: April 27, 2006
Last Updated: October 8, 2006

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

ClinicalTrials.gov processed this record on February 23, 2017