Evaluation of Mechanical Stapler for Aortic Anastomoses

Aortic Aneurysm, Abdominal Clinical Trial

Official title:

Evaluation of Mechanical Stapler for Aortic Anastomoses

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00319475
• Other study ID #: EU-DE 006
• Status: Active, not recruiting
• Phase: N/A
• First received: April 27, 2006
• Last updated: October 8, 2006
• Start date: February 2006
• Est. completion date: July 2006

Study information

• Verified date: October 2006
• Source: SVSE 2000 Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 85 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Leriche Syndrome

Intervention

Procedure:
• AAA or AF/IB (end-to-end) in patients with Leriche Syndrome

Locations

Country	Name	City	State
Germany	Augusta Hospital	Duesseldorf

Sponsors (1)

Lead Sponsor	Collaborator
SVSE 2000 Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to complete each stapled anastomosis.
Secondary	Post-operative follow up:
Secondary	no leakage
Secondary	no dilatation
Secondary	no fistula or hematoma at the anastomotic sites