Text Size

Evaluation of Mechanical Stapler for Aortic Anastomoses

The recruitment status of this study is unknown because the information has not been verified recently.
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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Mechanical Stapler for Aortic Anastomoses

Resource links provided by NLM:

U.S. FDA Resources

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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 19, 2013