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Endovascular Exclusion of Ascending and Thoracic Aortic Pathology

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00583817
Recruitment Status : Recruiting
First Posted : December 31, 2007
Last Update Posted : April 14, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to assess the role of ascending and/or aortic arch aneurysm/dissections treatment using a novel endovascular prosthesis in high risk surgical patients.

Condition or disease Intervention/treatment
Thoracic Aortic Aneurysms Dissecting, Aneurysm Ascending Aorta Aneurysm Aortic Arch; Aneurysm, Dissecting Ascending Aortic Dissection Device: Endovascular stent-graft implantation

Detailed Description:
This study is a prospective, non-randomized evaluation of ascending and thoracic pathology endovascular repair in the high-risk patient. The purpose of this study is to assess the role of the thoracic aortic pathology treatment using endovascular prosthesis in high-risk patients. 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. There will be up to 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 or MRI, chest x-ray, cardiac echo and ankle-brachial index.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endovascular Exclusion of Ascending and Thoracic Aortic Pathology
Study Start Date : May 2001
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Ascending Aortic Arm
Investigational endovascular stent-graft implantation to exclude aneurysm or repair dissection of the ascending aorta.
Device: Endovascular stent-graft implantation
Endovascular repair with a research device
Other Name: Cook Zenith
Experimental: Arch Branch Arm
Investigational endovascular stent-graft implantation to exclude aneurysm or repair dissection of the aortic arch.
Device: Endovascular stent-graft implantation
Endovascular repair with a research device
Other Name: Cook Zenith


Outcome Measures

Primary Outcome Measures :
  1. Freedom from aneurysm rupture [ Time Frame: 2 years ]
    Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

i)Life expectancy greater than 2 years ii) Suitable arterial anatomy iii) Absence of systemic disease or allergy that precludes an endovascular repair iv) Capable of giving informed consent and willingness to comply with follow up schedule v) Patient is considered high or prohibitive risk for open surgical repair of the ascending aneurysm or dissection

Exclusion Criteria:

Patient excluded if ANY of the following are true:

i) Pregnancy ii) History of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately iii) Allergy to stainless steel or polyester (allergy to stainless steel is not relevant if the Low Profile device is to be used) iv) Unwilling to comply with follow up schedule v) Serious or systemic groin infection vi) An uncorrectable coagulopathy

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Principal Investigator: Matthew Eagleton, MD         
Sub-Investigator: Eric Roselli, MD         
Sub-Investigator: Federico E Parodi, MD         
Sponsors and Collaborators
Matthew Eagleton
The Cleveland Clinic
Investigators
Principal Investigator: Matthew J Eagleton, MD The Cleveland Clinic
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Matthew Eagleton, Staff, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00583817     History of Changes
Other Study ID Numbers: G000101
IRB 3917 ( Other Identifier: Cleveland Clinic IRB )
First Posted: December 31, 2007    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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