Zenith® p-Branch™: Single-Center Study

NCT ID: NCT01663064

Last Updated: 2020-07-31

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

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2020-03-16

Brief Summary

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The Zenith® p-Branch™: Single-Center Study is a clinical trial approved by Swedish Regulatory Authority to study the safety and effectiveness of the Zenith® p-Branch™ in the treatment of abdominal aortic aneurysms.

Detailed Description

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Conditions

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Aortic Aneurysm Abdominal Aortic Aneurysm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endovascular

Endovascular treatment

Group Type EXPERIMENTAL

Endovascular treatment (Zenith® p-Branch™ endovascular graft)

Intervention Type DEVICE

Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.

Interventions

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Endovascular treatment (Zenith® p-Branch™ endovascular graft)

Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Pararenal or juxtarenal AAA \>5.0 cm in diameter
* Pararenal or juxtarenal AAA with history of growth \>0.5 cm/year

Exclusion Criteria

* Age \< 18 years
* Life expectancy \< 2 years
* Pregnant or breast feeding
* Inability or refusal to give informed consent by the patient or a legally authorized representative
* Unwilling or unable to comply with the follow-up schedule
* Additional medical restrictions as specified in the Clinical Investigation Plan
* Additional anatomical restrictions as specified in the Clinical Investigation Plan
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy A. Resch, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Skane University Hospital

Locations

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Skane University Hospital

Malmo, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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11-018

Identifier Type: -

Identifier Source: org_study_id

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