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Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices (CARPE-CMD)

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ClinicalTrials.gov Identifier: NCT02050113
Recruitment Status : Recruiting
First Posted : January 30, 2014
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Andres Schanzer, University of Massachusetts, Worcester

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of custom made devices, Zenith t-Branch devices and physician modification of FDA approved off-the-shelf endovascular grafts in the treatment of patients with complex abdominal aneurysms, aortoiliac aneurysms or thoracoabdominal aneurysms who (1) have anatomy not suitable for endovascular repair using grafts currently marketed in the United States,(2) are deemed unsafe to wait the required time necessary for commercial endograft manufacturing, and (3) are at high risk for open surgical repair.

Condition or disease Intervention/treatment Phase
Complex Aortic Aneurysms Thoracoabdominal Aneurysms Pararenal Aneurysms Juxtarenal Aneurysms Device: Physician modified stent graft Not Applicable

Detailed Description:

Endovascular repair of complex aortic aneurysms is limited by the need to maintain blood flow to the critical organs that receive blood from the aorta, such as the kidneys, liver and intestines. While there are some commercially available devices that may treat some of these patients these devices may not be suitable or available for a given patient. In this study we will use custom made devices manufactured by Cook, Inc, Zenith t-Branch devices and off-the-shelf, FDA approved devices which are altered by creating fenestrations (holes) in the stent graft that allow additional stents to be inserted into the blood vessels that supply blood to these critical organs.

Determination of which type of endograft to use will be based on the patient's anatomy and the perceived urgency of the need for repair. This decision will be made by the study team and confirmed by a 3rd party reviewer who is not an investigator on the study team. After ensuring that a patient meets inclusion and exclusion criteria for participation in the CARPE-CMD study, the perceived urgency for repair will be evaluated given the 8-10 week required time for manufacture of a CMD device.

If the patient's aneurysm is not symptomatic and if, at the discretion of the treating surgeon, the patient is deemed safe to wait 8 weeks until repair, the patient will be considered non-urgent. Non-urgent patients will undergo repair with a CMD device.

If the patient's aneurysm is symptomatic and if, at the discretion of the treating surgeon, the patient is deemed unsafe to wait 8 weeks until repair, the patient will be considered urgent. Urgent patients will undergo repair with a t-branch device (if anatomy suitable) if they are deemed safe to wait for the device to be obtained (<72 hours). Urgent patients who do not have anatomy suitable to a t-branch device or patients who are not deemed safe to wait for the device to be obtained, will undergo repair with a physician modified device.

The device is inserted into the body through two small punctures or incisions in the groin. Small stents will be inserted through the stent graft fenestrations into the major blood vessels affected by the aneurysm so that blood flow is maintained to these organs.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices
Study Start Date : March 2014
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Endovascular repair
Endovascular repair of Complex Aortic Aneurysm using a physician modified stent graft
Device: Physician modified stent graft
The surgeon will modify commercially available stent grafts to match the anatomy of the patient being treated. Small fenestrations (holes) will be made in the stent graft so that additional stents can be inserted through the fenestration and into the blood vessels that lead to the kidneys, intestines or liver. These stents allow blood to flow freely to these organs. This surgery is done through small incisions in the groin.




Primary Outcome Measures :
  1. The effectiveness of physician modified endovascular grafts will be determined by evaluating the proportion of patients that achieve Treatment Success [ Time Frame: 12 months post procedure ]
    Treatment success is a combination of technical success, and freedom at 12 months from the following: Type 1 and 3 Endoleaks, Stent migration of more than 10 mm, aortic aneurysm enlargement sac enlargement of more than 5 mm, aneurysm rupture and conversion to open repair.


Secondary Outcome Measures :
  1. Incidence of Major Adverse Events [ Time Frame: Within 30 days of the initial procedure ]
    Major adverse events include death, myocardial infarction, stroke, respiratory failure, paralysis, bowel ischemia, and procedural blood loss of greater than 1 liter.



Information from the National Library of Medicine

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

Inclusion Criteria:

  • A patient may be suitable for inclusion in the study if the patient has at least one of the following:

    1. Aortic or aortoiliac aneurysm with diameter ≥5.5 cm
    2. Aortic or aortoiliac aneurysm with a history of growth ≥1.0 cm per year, or clinical indication for aneurysm repair based on symptoms

      General Inclusion Criteria

    1. Cannot be treated with a currently available non-modified approved device
    2. Symptomatic on presentation and unsafe to wait for the time necessary to obtain a currently available non-modified approved device
    3. At least 18 years of age
    4. Not pregnant or breastfeeding
    5. Willing and able to comply with five years of follow-up
    6. Willing and able to provide informed consent prior to enrollment
    7. No systemic or local infection that may increase the risk of endovascular graft infection
    8. High risk for open surgical repair based on any of the factors below:

      a. Anatomic i. Previous abdominal surgery ii. Previous left-sided thoracotomy (if the proposed open repair would require dissection of the thoracic aorta) iii. Previous aortic surgery b. Physiologic i. ASA Category III or higher ii. Age >70 years iii. Current tobacco use iv. Previous myocardial infarction, coronary artery disease, or coronary artery stent v. Coronary stress test with a reversible perfusion defect vi. Congestive heart failure vii. COPD

Exclusion Criteria:

  • Exclusion Criteria Medical Exclusion Criteria 1. Cultural objection to receipt of blood or blood products 2. Allergy or sensitivity to stainless steel, polyester, polypropylene, solder (tin, silver), gold, or nitinol 3. Anaphylactic reaction to contrast that cannot be adequately pre-medicated 4. Uncorrectable coagulopathy 5. Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina) 6. Patient has a major surgical or interventional procedure planned ≤30 days of the aneurysm repair 8. Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome) 9. Patient has active malignancy 10. Patient has life expectancy less than two years

Anatomical Exclusion Criteria

  1. Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access
  2. Proximal neck length ≤25 mm
  3. Proximal neck, measured outer wall to outer wall on a sectional image (CT)

    1. For use of Zenith Flex: diameter >32 mm or <18 mm
    2. For use of Zenith TX2: diameter >38 mm or <24 mm (for proximal and distal neck diameter)
  4. Proximal neck angulated more than 60 degrees relative to the long axis of the aneurysm
  5. Proximal neck diameter change over the length of the proximal seal zone >4 mm
  6. Proximal seal site with a circumferential thrombus/atheroma
  7. Iliac artery diameter, measured inner wall to inner wall on a sectional image (CT) <7.0 mm at any point along access length (prior to deployment)
  8. Ipsilateral iliac artery fixation site diameter, measured inner wall on a sectional image (CT) >21 mm at distal fixation site
  9. Iliac artery distal fixation site <10 mm in length
  10. Non-bifurcated segment of any artery to be stented < 15 mm in length
  11. Artery to be stented with a maximum diameter <3 mm or >10 mm at the vessel ostium
  12. Inability to maintain at least one patent hypogastric artery

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): NCT02050113


Contacts
Contact: Shauneen Valliere, MSN, NP 508-856-1767 shauneen.valliere@umassmed.edu
Contact: Andres Schanzer, MD 508-856-5599 andres.schanzer@umassmemorial.org

Locations
United States, Massachusetts
UMass Memorial Health Care - University Campus Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Shauneen Valliere, MSN, NP    508-856-1767    shauneen.valliere@umassmed.edu   
Contact: Andres Schanzer, MD    508-856-5599    andres.schanzer@umassmemorial.org   
Principal Investigator: Andres Schanzer, MD         
Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Andres Schanzer, MD University of Massachusetts, Worcester

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andres Schanzer, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT02050113     History of Changes
Other Study ID Numbers: CARPE-01
First Posted: January 30, 2014    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018

Keywords provided by Andres Schanzer, University of Massachusetts, Worcester:
Complex Aortic Aneurysms
Thoracoabdominal Aneurysms
Pararenal Aortic Aneurysms
Juxtarenal Renal Aneurysms
Endovascular Branch Graft
Fenestrated Stent Graft
Abdominal Aortic Aneurysm
Endovascular

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases