Evaluation of Mechanical Stapler for Aortic Anastomoses

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

Study Overview

• Status: Unknown
• Conditions: Aortic Aneurysm, Abdominal; Leriche Syndrome
• Intervention / Treatment: Procedure: AAA or AF/IB (end-to-end) in patients with Leriche Syndrome

• Study Type: Interventional
• Enrollment: 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Duesseldorf, Germany, 40472
    • Augusta Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to complete each stapled anastomosis.

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: SVSE 2000 Ltd.
• Investigators: Principal Investigator: Ralf Kolvenbach, MD, Augusta Hospital, Berlin

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Study Completion: July 1, 2006

Study Registration Dates

• First Submitted: April 27, 2006
• First Submitted That Met QC Criteria: April 27, 2006
• First Posted (ESTIMATE): April 27, 2006

Study Record Updates

• Last Update Posted (ESTIMATE): October 11, 2006
• Last Update Submitted That Met QC Criteria: October 8, 2006
• Last Verified: October 1, 2006

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Leriche Syndrome
• Other Study ID Numbers: EU-DE 006