Evaluation of Mechanical Stapler for Aortic Anastomoses - Full Text View

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

MedlinePlus related topics:

Aneurysms

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:	Evaluation of Mechanical Stapler for Aortic Anastomoses

Further study details as provided by SVSE 2000 Ltd.:

Primary Outcome Measures:

Secondary Outcome Measures:

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

Eligibility

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

Sponsors and Collaborators

SVSE 2000 Ltd.

Investigators


Principal Investigator:	Ralf Kolvenbach, MD	Augusta Hospital, Berlin

More Information

Study ID Numbers:	EU-DE 006
First Received:	April 27, 2006
Last Updated:	October 8, 2006
ClinicalTrials.gov Identifier:	NCT00319475
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Arterial Occlusive Diseases

Aortic Diseases

Aneurysm

Aortic Aneurysm, Abdominal

Abdominal aortic aneurysm

Vascular Diseases

Leriche Syndrome

Aortic Aneurysm

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 06, 2008

Sponsored by:	SVSE 2000 Ltd.
Information provided by:	SVSE 2000 Ltd.
ClinicalTrials.gov Identifier:	NCT00319475