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Endovascular Exclusion of Thoracic Aortic Aneurysms

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by The Cleveland Clinic
The Cleveland Clinic
Information provided by (Responsible Party):
Matthew Eagleton, Cleveland Clinic Foundation Identifier:
First received: December 20, 2007
Last updated: October 3, 2016
Last verified: October 2016
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
Dissecting, Aneurysm
Thoracoabdominal Aneurysms
Device: Endovascular stent-graft implantation
Phase 1

Study Type: Interventional
Study Design: 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:
  • Freedom from aneurysm rupture [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan

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
Experimental: Endovascular Aneurysm or Dissection Repair
Investigational stent-graft implantation to exclude aneurysm or repair dissection
Device: Endovascular stent-graft implantation
Endovascular repair with a research device
Other Name: Cook Zenith

Detailed Description:
This study is a prospective, non-randomized evaluation of thoracic aneurysm endovascular repair in the high-risk patient. The purpose of this study is to assess the role of the thoracic aortic aneurysm exclusion using endovascular prosthesis in high-risk patients. Patients with aneurysms that involve the aortic arch or aneurysms that require surgical modification of the proximal or distal attachment sites are also included in the study. The study objectives include (1) to assess the safety and efficacy of endovascular prosthesis as a means of preventing aneurysm growth and rupture in high risk patients, (2) to measure the physiologic effects and outcomes of endovascular aneurysm repair, (3) to establish selection criteria, improve device design, operative technique, and follow-up procedures for patients undergoing aneurysm repair. Up to 250 patients are to be enrolled in the non-urgent arm, up to 174 patients in the Symptomatic or Rupture arm, 15 patients in the ascending aortic lesion arm, and 20 patients in Arch Branch arm, all at one site (The Cleveland Clinic). Baseline procedures may include an angiogram, intravascular ultrasound, CT scan, chest x-ray, physical exam, blood work, and ankle-brachial index. The endovascular prosthesis is placed in the operating room under regional or general anesthesia. Follow-up evaluations may include physical exam, blood work, CT scan, chest x-ray, cardiac echo and ankle-brachial index.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT00583817

Contact: Yuki Kuramochi, RN, BSN 216-445-4063

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Matthew Eagleton, Staff, Cleveland Clinic Foundation Identifier: NCT00583817     History of Changes
Other Study ID Numbers: G000101  IRB 3917 
Study First Received: December 20, 2007
Last Updated: October 3, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases processed this record on October 21, 2016