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Endovascular Exclusion of Thoracic Aortic Aneurysms

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by The Cleveland Clinic
Sponsor:
Collaborator:
Eagleton, Matthew, M.D.
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00583817
First received: December 20, 2007
Last updated: November 8, 2014
Last verified: November 2014
  Purpose

The purpose of this study is to assess the role of ascending, arch or descending thoracic aortic aneurysm exclusion using a novel endovascular prosthesis in high risk surgical patients.


Condition Intervention Phase
Thoracic Aortic Aneurysms
Thoracic Aortic Dissections
Thoracoabdominal Aneurysms
Device: Endovascular stent-graft implantation
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endovascular Exclusion of Thoracic Aortic Aneurysms

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Safety [ Time Frame: Undecided ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 459
Study Start Date: May 2001
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Primary Arm
Device: Endovascular stent-graft implantation
Endovascular repair with a research device
Other Name: Cook Zenith
2
Symptomatic/Rupture Arm
Device: Endovascular stent-graft implantation
Endovascular repair with a research device
Other Name: Cook Zenith
3
Ascending Aortic Arm
Device: Endovascular stent-graft implantation
Endovascular repair with a research device
Other Name: Cook Zenith
4
Arch Branch Arm
Device: Endovascular stent-graft implantation
Endovascular repair with a research device
Other Name: Cook Zenith

  Eligibility

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

Inclusion Criteria:

  1. High risk for conventional surgical treatment of their aortic disease
  2. Life expectancy greater than 2 years
  3. Suitable arterial anatomy
  4. Absence of systemic disease or allergy that precludes an endovascular repair
  5. Capable of giving informed consent and willingness to comply with follow up schedule

Exclusion Criteria:

  1. Pregnancy
  2. History of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately
  3. Allergy to stainless steel or polyester
  4. Unwilling to comply with follow up schedule
  5. Serious or systemic groin infection
  6. An uncorrectable coagulopathy
  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: NCT00583817

Contacts
Contact: Yuki Kuramochi, RN, BSN 216-445-4063 kuramoy@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Sub-Investigator: Daniel Clair, MD         
Sub-Investigator: Sean Lyden, MD         
Principal Investigator: Matthew Eagleton, MD         
Sub-Investigator: Eric Roselli, MD         
Sub-Investigator: Federico E Parodi, MD         
Sponsors and Collaborators
The Cleveland Clinic
Eagleton, Matthew, M.D.
Investigators
Principal Investigator: Matthew J Eagleton, MD The Cleveland Clinic
  More Information

No publications provided by The Cleveland Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00583817     History of Changes
Other Study ID Numbers: G000101, IRB 3917
Study First Received: December 20, 2007
Last Updated: November 8, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 27, 2014