Trials Sponsors Conditions Drugs Pricing

Conditions

Aortic Aneurysm Penetrating Ulcer Vascular Disease

Keywords

Aortic AneurysmAneurysmVascular ProsthesisVascular DiseaseBlood Vessel Prosthesis Implantation

Outcome Measures

Primary Outcomes (2)

Patients With Major Adverse Events (MAE)
Major adverse event is defined as: All-cause death; Q-wave MI; cardiac event involving arrest, resuscitation, or balloon pump; ventilation \> 72 hours or re-intubation; pulmonary event requiring tracheostomy or chest tube; renal failure requiring permanent dialysis, hemofiltration, or kidney transplant in a patient with a normal pre-procedure serum creatinine level; bowel resection; stroke; paralysis; amputation involving more than toes; aneurysm or vessel leak requiring re-operation; deep vein thrombosis requiring surgical or lytic therapy; pulmonary embolism involving hemodynamic instability or surgery; coagulopathy requiring surgery; or wound complication requiring return to the operating room.
30 days
Patients With Device Failures
Device failure is defined as: Technical failure (inability to access or deploy the Zenith® TX2® Low Profile TAA Endovascular Graft or loss of patency at the time of deployment completion), or any of the following: type I or type III endoleaks requiring re-intervention, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm.
12 months

Study Arms (1)

Arm 1

EXPERIMENTAL

Zenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm)

Device: Zenith® TX2® Low Profile TAA Endovascular Graft

Interventions

Zenith® TX2® Low Profile TAA Endovascular GraftDevice

Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair

Also known as: Zenith Alpha Thoracic™ Endovascular Graft, TEVAR

Arm 1

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Descending thoracic aneurysm with diameter ≥ 5.0 cm
Descending thoracic aneurysm with a history of growth ≥ 0.5 cm per year

Sponsors & Collaborators

Cook Research Incorporated
Industrylead

Study Sites (33)

Kaiser Permanente

San Francisco, California, 94115, United States

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

University of South Florida

Tampa, Florida, 33606, United States

Emory University

Atlanta, Georgia, 30322, United States

Methodist Hospital of Indiana

Indianapolis, Indiana, 46202, United States

Indiana Heart Hospital

Indianapolis, Indiana, 46250, United States

University of Michigan

Ann Arbor, Michigan, 48109, United States

MeSH Terms

Conditions

Aortic AneurysmPenetrating Atherosclerotic UlcerVascular DiseasesAneurysm

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesAortic DiseasesAcute Aortic SyndromeArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical Procedures

Results Point of Contact

Title: Alan Saunders, MS, RAC; Manager, Biostatistics
Organization: Cook Research Incorporated

Study Officials

Karl Illig, MD
University of South Florida
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: GT60
Restrictive Agreement: Yes

Enrollment

110 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR
Expanded Access: Yes

Study Record Dates

First Submitted

June 22, 2010

First Posted

June 25, 2010

Study Start

March 2010

Date type not reported

This date has not been verified as actual or estimated.

TX2® Low Profile TAA Endovascular Graft

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Arm 1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (33)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Results Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

Arm 1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (33)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations