Evaluation of Mechanical Stapler for Aortic Anastomoses | NCT00319475

Studies
Evaluation of Mechanical Stapler for Aortic Anastomoses

NCT00319475

Sponsor

SVSE 2000 Ltd.

Status

Unknown status

Last Update Posted

Oct 11, 2006Estimated

Enrollment

Phase

Not Applicable

Conditions

Aortic Aneurysm, Abdominal
Leriche Syndrome

Interventions

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

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2006

Primary Completion Date

Not provided

Completion Date

Jul 2006

First Submitted Date

Apr 27, 2006

First Submission Date that Met QC Criteria

Apr 27, 2006

First Posted Date

Apr 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2006

Last Update Posted Date

Oct 11, 2006Estimated

Description Module

Brief 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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
AAA or AF/IB (end-to-end) in patients with Leriche Syndrome	Procedure

Measure	Description	Time Frame
Time to complete each stapled anastomosis.

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ralf Kolvenbach, MD	Augusta Hospital, Berlin	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Augusta Hospital		Düsseldorf		40472	Germany

Condition Browse Module

MeSH Terms

ID	Term
D017544	Aortic Aneurysm, Abdominal
D007925	Leriche Syndrome

Ancestor Terms

ID	Term
D001014	Aortic Aneurysm
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Post-operative follow up:
no leakage
no dilatation