Zenith TX2-Low-Profile (LP) Clinical Study (TX2-LP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00923754
First received: June 16, 2009
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

The Zenith TX2-LP Clinical Study is a small, early clinical experience trial approved by the German (BfArM), Swedish (Läkemedelsverket), British (MHRA) and Italian (MoH) authorities to study the safety and effectiveness of the Zenith TX2® TAA Low-Profile Endovascular Graft in the treatment of thoracic aortic aneurysms in Germany, Sweden, Britain and Italy.


Condition Intervention
Descending Thoracic Aortic Aneurysm
Device: Zenith TX2(R) TAA Low-Profile Endovascular Graft

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Zenith TX2® TAA Low-Profile Endovascular Graft Clinical Study

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Deployment and procedural success [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Thoracic aortic aneurysm-related mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: March 2010
Estimated Study Completion Date: March 2018
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endovascular Repair
Treatment Arm
Device: Zenith TX2(R) TAA Low-Profile Endovascular Graft
Endovascular treatment with the study device
Other Name: TEVAR

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Descending thoracic aortic aneurysm with diameter ≥ 5.0 cm; or
  • Descending thoracic aortic aneurysm with a history of growth ≥ 0.5 cm within the previous 12 months; or
  • Descending thoracic aortic degenerative or atherosclerotic ulcers ≥ 10 mm in depth and 20 mm in diameter

Exclusion Criteria:

  • Age < 18 years
  • Other medical condition that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., less than 2 years)
  • Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
  • Unwilling or unable to comply with the follow-up schedule
  • Inability or refusal to give informed consent
  • Less than 30 days beyond primary endpoint in another investigative device or drug study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923754

Locations
Germany
Hannover Medical School
Hannover, Germany
St. Franziskus Hospital
Munster, Germany
Klinikum Nürnberg Sud
Nürnberg, Germany, 90471
Uniklinik Regensburg
Regensburg, Germany
University Hospital Rostock
Rostock, Germany, 18057
Italy
Hospital San Raffaele
Milan, Italy, 20132
Sweden
Malmö University Hospital
Malmö, Sweden
United Kingdom
St. George's Hospital
London, United Kingdom, SW 17 0QT
Sponsors and Collaborators
Cook
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00923754     History of Changes
Other Study ID Numbers: 08-017, 430030, TXLP
Study First Received: June 16, 2009
Last Updated: February 5, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ministry of Health
Sweden: Medical Products Agency

Keywords provided by Cook:
Endovascular Aneurysm Repair
Aortic Aneurysm
Thoracic

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on July 23, 2014