TX2® Low Profile TAA Endovascular Graft

NCT01151020 | Completed Results

• 1 other identifier: 10-001
• Study Type: interventional
• Target: 110
• Locations: 6 countries
• Sites: 33

Brief Summary

The Zenith® TX2® Low Profile TAA Endovascular Graft study is a clinical trial approved by US FDA to evaluate the safety and effectiveness of the Zenith® TX2® Low Profile TAA Endovascular Graft indicated for the treatment of patients with aneurysms/ulcers of the descending thoracic aorta having vessel structure suitable for repair.

Conditions

Aortic Aneurysm; Penetrating Ulcer; Vascular Disease

Keywords

Aortic Aneurysm; Aneurysm; Vascular Prosthesis; Vascular Disease; Blood 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 Graft DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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
• Descending thoracic degenerative or atherosclerotic ulcer ≥ 10 mm in depth and 20 mm in diameter

You may not qualify if:

• Less than 18 years of age
• Life expectancy less than 2 years
• Pregnant or breastfeeding or planning on becoming pregnant within 60 months
• Unwilling to comply with the follow-up schedule
• Inability or refusal to give informed consent
• Less than 30 days beyond primary endpoint for other investigative drug or device study

Sponsors & Collaborators

• Cook Research Incorporated: lead

Study Sites (33)

Kaiser Permanente

San Francisco, California, 94115, United States

Location

Washington Hospital Center

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

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Methodist Hospital of Indiana

Indianapolis, Indiana, 46202, United States

Location

Indiana Heart Hospital

Indianapolis, Indiana, 46250, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Cooper University Hospital

Camden, New Jersey, 08103, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

New York University Hospital

New York, New York, 10016, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Tennessee Baptist Memorial Hospital

Memphis, Tennessee, 38120, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Hannover Medical School

Hanover, Germany

Location

St. Franziskus Hospital

Münster, Germany

Location

Klinikum Nürnberg Sud

Nuremberg, 90471, Germany

Location

Uniklinik Regensburg

Regensburg, Germany

Location

University Hospital Rostock

Rostock, 18057, Germany

Location

Hospital San Raffaele

Milan, 20132, Italy

Location

Morinomiya Hospital

Osaka, Japan

Location

Jikei University School of Medicine

Tokyo, 105-8461, Japan

Location

Keio University Hospital

Tokyo, 160-8582, Japan

Location

Malmö University Hospital

Malmo, Sweden

Location

St.George's Hospital

London, SW 17 0QT, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm; Penetrating Atherosclerotic Ulcer; Vascular Diseases; Aneurysm

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Aortic Diseases; Acute Aortic Syndrome; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Results Point of Contact

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

Alan.Saunders@CookMedical.com

765-463-7537

Study Officials

• Karl Illig, MD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

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 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: May 11, 2018
• Last Updated: January 22, 2021
• Results First Posted: February 29, 2016

Record last verified: 2021-01

Locations

US (22); IT (1); GB (1); DE (5); JP (3); SE (1)