Acute Technical Outcomes of the Talent Abdominal Aortic Aneurysm (AAA) Stent-Graft Versus Cook Zenith Stent-Graft

NCT ID: NCT00922454

Last Updated: 2009-06-17

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

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2011-06-30

Brief Summary

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The purpose of this study is to compare acute technical outcomes of the Talent AAA Stent Graft system versus Cook Zenith Endograft at two high volume institutions, Albany Medical Center and St. Peter's Hospital in Albany, NY.

The investigators are comparing the two devices as part of the evolution of endovascular repair (EVAR) for AAAs. The Zenith AAA Endovascular Graft received FDA approval on May 23, 2003, the Talent Abdominal Stent Graft System on April 15, 2008.

Detailed Description

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Conditions

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Abdominal Aortic Aneurysm

Study Design

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Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Talent Stent-Graft

Group Type EXPERIMENTAL

Endovascular Repair of the abdominal aorta

Intervention Type PROCEDURE

Patients will undergo or have undergone endovascular aneurysm repair which is minimally invasive approach using endoluminal placement of a stent graft.

EVAR, CTA imaging, 1, 6 12 months post treatment.

Talent Stent-Graft

Intervention Type DEVICE

Talent AAA Abdominal Stent Graft System

Cook Zenith Stent-Graft

Group Type EXPERIMENTAL

Endovascular Repair of the abdominal aorta

Intervention Type PROCEDURE

Patients will undergo or have undergone endovascular aneurysm repair which is minimally invasive approach using endoluminal placement of a stent graft.

EVAR, CTA imaging, 1, 6 12 months post treatment.

Cook Zenith Stent-Graft

Intervention Type DEVICE

Cook Zenith AAA Endovascular Graft

Interventions

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Endovascular Repair of the abdominal aorta

Patients will undergo or have undergone endovascular aneurysm repair which is minimally invasive approach using endoluminal placement of a stent graft.

EVAR, CTA imaging, 1, 6 12 months post treatment.

Intervention Type PROCEDURE

Cook Zenith Stent-Graft

Cook Zenith AAA Endovascular Graft

Intervention Type DEVICE

Talent Stent-Graft

Talent AAA Abdominal Stent Graft System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* subject with abdominal aortic aneurysm, with or without iliac involvement
* iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories

Exclusion Criteria

* less than 18 years of age
* pregnant or lactating
* have contraindications for use of contrast medium or anticoagulation drugs
* are patients who have a condition that threatens to infect the graft
* are patients with sensitivities or allergies to the device materials
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Center for Vascular Awareness, Albany, New York

OTHER

Sponsor Role lead

Responsible Party

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The Vascular Group, PLLC

Principal Investigators

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Manish Mehta, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

The Vascular Group, PLLC

Locations

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Albany Medical Center, 47 New Scotland Ave.

Albany, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Deborah Hill, RN

Role: CONTACT

518 45202198

Anita Suchdeve, RN

Role: CONTACT

518 452-1263

Facility Contacts

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Anita Suchdeve, RN

Role: primary

518-452-1263

Deborah Hill, RN

Role: backup

(518) 452-1298

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id

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