Evaluation of Mechanical Stapler for Aortic Anastomoses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2006-07-31

Brief Summary

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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

Detailed Description

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Conditions

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Aortic Aneurysm, Abdominal Leriche Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Ralf Kolvenbach, MD

Role: PRINCIPAL_INVESTIGATOR

Augusta Hospital, Berlin

Locations

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Augusta Hospital

Düsseldorf, , Germany

Site Status

Countries

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Germany

Other Identifiers

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EU-DE 006

Identifier Type: -

Identifier Source: org_study_id