Overview

This trial is active, not recruiting.

Conditions aortic aneurysm, abdominal, leriche syndrome
Treatment aaa or af/ib (end-to-end) in patients with leriche syndrome
Sponsor SVSE 2000 Ltd.
Start date February 2006
End date July 2006
Trial size 10 participants
Trial identifier NCT00319475, EU-DE 006

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Time to complete each stapled anastomosis.
time frame:

Secondary Outcomes

Measure
Post-operative follow up:
time frame:
no leakage
time frame:
no dilatation
time frame:
no fistula or hematoma at the anastomotic sites
time frame:

Eligibility Criteria

Male or female participants from 21 years up to 85 years old.

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

Additional Information

Official title Evaluation of Mechanical Stapler for Aortic Anastomoses
Principal investigator Ralf Kolvenbach, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2006.
Information provided to ClinicalTrials.gov by SVSE 2000 Ltd..