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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
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Matthew Eagleton, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier:
NCT00583817
First received: December 20, 2007
Last updated: October 3, 2016
Last verified: October 2016

December 20, 2007
October 3, 2016
May 2001
December 2020   (final data collection date for primary outcome measure)
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
Saftey [ Time Frame: Undecided ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00583817 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Endovascular Exclusion of Thoracic Aortic Aneurysms
Endovascular Exclusion of Thoracic Aortic Aneurysms
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.
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.
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Thoracic Aortic Aneurysms
  • Dissecting, Aneurysm
  • Thoracoabdominal Aneurysms
Device: Endovascular stent-graft implantation
Endovascular repair with a research device
Other Name: Cook Zenith
Experimental: Endovascular Aneurysm or Dissection Repair
Investigational stent-graft implantation to exclude aneurysm or repair dissection
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
459
December 2020
December 2020   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact: Yuki Kuramochi, RN, BSN 216-445-4063 kuramoy@ccf.org
United States
 
NCT00583817
G000101, IRB 3917
Yes
No
Not Provided
Matthew Eagleton, Cleveland Clinic Foundation
Matthew Eagleton
The Cleveland Clinic
Principal Investigator: Matthew J Eagleton, MD The Cleveland Clinic
The Cleveland Clinic
October 2016

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