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Endovascular Exclusion of Ascending and Thoracic Aortic Pathology

This study is currently recruiting participants.
Verified April 2017 by Matthew Eagleton, The Cleveland Clinic
Sponsor:
ClinicalTrials.gov Identifier:
NCT00583817
First Posted: December 31, 2007
Last Update Posted: April 14, 2017
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.
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Matthew Eagleton, The Cleveland Clinic
December 20, 2007
December 31, 2007
April 14, 2017
May 2001
December 2020   (Final data collection date for primary outcome measure)
Freedom from aneurysm rupture [ Time Frame: 2 years ]
Absence of blood extravasation outside of aneurysm sac demonstrated by CT scan
Saftey [ Time Frame: Undecided ]
Complete list of historical versions of study NCT00583817 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Endovascular Exclusion of Ascending and Thoracic Aortic Pathology
Endovascular Exclusion of Ascending and Thoracic Aortic Pathology
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.
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.
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Thoracic Aortic Aneurysms
  • Dissecting, Aneurysm
  • Ascending Aorta Aneurysm
  • Aortic Arch; Aneurysm, Dissecting
  • Ascending Aortic Dissection
Device: Endovascular stent-graft implantation
Endovascular repair with a research device
Other Name: Cook Zenith
  • Experimental: Ascending Aortic Arm
    Investigational endovascular stent-graft implantation to exclude aneurysm or repair dissection of the ascending aorta.
    Intervention: Device: Endovascular stent-graft implantation
  • Experimental: Arch Branch Arm
    Investigational endovascular stent-graft implantation to exclude aneurysm or repair dissection of the aortic arch.
    Intervention: Device: Endovascular stent-graft implantation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
35
December 2020
December 2020   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Yuki Kuramochi, RN, BSN 216-445-4063 kuramoy@ccf.org
United States
 
 
NCT00583817
G000101
IRB 3917 ( Other Identifier: Cleveland Clinic IRB )
Yes
Not Provided
Plan to Share IPD: No
Matthew Eagleton, The Cleveland Clinic
Matthew Eagleton
The Cleveland Clinic
Principal Investigator: Matthew J Eagleton, MD The Cleveland Clinic
The Cleveland Clinic
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP