Cleveland, Ohio 44195


Purpose:

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.


Study summary:

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.


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


NCT ID:

NCT00583817


Primary Contact:

Principal Investigator
Matthew J Eagleton, MD
The Cleveland Clinic

Yuki Kuramochi, RN, BSN
Phone: 216-445-4063
Email: kuramoy@ccf.org


Backup Contact:

N/A


Location Contact:

Cleveland, Ohio 44195
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

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