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

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: NCT02050113
Recruitment Status : Recruiting
First Posted : January 30, 2014
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
Andres Schanzer, University of Massachusetts, Worcester

Tracking Information
First Submitted Date  ICMJE January 28, 2014
First Posted Date  ICMJE January 30, 2014
Last Update Posted Date October 30, 2019
Study Start Date  ICMJE March 2014
Estimated Primary Completion Date March 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices
Official Title  ICMJE Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices
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. Amendment to the study has created a cohort open to people with connective tissue diseases such as Marfan, Ehlers-Danlos or Loey-Dietz syndromes to enroll in the trial.
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 6-8 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) 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Complex Aortic Aneurysms
  • Thoracoabdominal Aneurysms
  • Pararenal Aneurysms
  • Juxtarenal Aneurysms
  • Marfan Syndrome
  • Ehlers-Danlos Syndrome
  • Loeys-Dietz Syndrome
Intervention  ICMJE Device: Custom Made Fenestrated or Branched Stent Graft
The surgeon will place a custom made graft, t-Branch device or 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.
Other Names:
  • t-Branch Device
  • Physcian Modified Device
Study Arms  ICMJE Experimental: Endovascular repair
Endovascular repair of Complex Aortic Aneurysm using a physician modified stent graft
Intervention: Device: Custom Made Fenestrated or Branched Stent Graft
Publications * Schanzer A, Baril D, Robinson WP 3rd, Simons JP, Aiello FA, Messina LM. Developing a complex endovascular fenestrated and branched aortic program. J Vasc Surg. 2015 Mar;61(3):826-31. doi: 10.1016/j.jvs.2014.08.121. Epub 2015 Jan 13.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 13, 2018)
300
Original Estimated Enrollment  ICMJE
 (submitted: January 28, 2014)
25
Estimated Study Completion Date  ICMJE March 2030
Estimated Primary Completion Date March 2030   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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. Previous myocardial infarction, coronary artery disease, or coronary artery stent iv. Coronary stress test with a reversible perfusion defect v. Congestive heart failure vi. 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 active malignancy with life expectancy of less than 2 years
    7. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shauneen Valliere, MSN, NP 508-856-1767 shauneen.valliere@umassmed.edu
Contact: Andres Schanzer, MD 508-856-5599 andres.schanzer@umassmemorial.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02050113
Other Study ID Numbers  ICMJE CARPE-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andres Schanzer, University of Massachusetts, Worcester
Study Sponsor  ICMJE University of Massachusetts, Worcester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andres Schanzer, MD University of Massachusetts, Worcester
PRS Account University of Massachusetts, Worcester
Verification Date October 2019

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