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

Primary Purpose

Complex Aortic Aneurysms, Thoracoabdominal Aneurysms, Pararenal Aneurysms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Custom Made Fenestrated or Branched Stent Graft
Sponsored by
Andres Schanzer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complex Aortic Aneurysms focused on measuring Complex Aortic Aneurysms, Thoracoabdominal Aneurysms, Pararenal Aortic Aneurysms, Juxtarenal Renal Aneurysms, Endovascular Branch Graft, Fenestrated Stent Graft, Abdominal Aortic Aneurysm, Endovascular, Aortic Dissection, Aortic Arch Aneurysms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UMass Memorial Health Care - University CampusRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endovascular repair

Arm Description

Endovascular repair of Complex Aortic Aneurysm using a physician modified stent graft. custom made device or arch branch device.

Outcomes

Primary Outcome Measures

The effectiveness of physician modified endovascular grafts will be determined by evaluating the proportion of patients that achieve Treatment Success
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

Incidence of Major Adverse Events
Major adverse events include death, myocardial infarction, stroke, respiratory failure, paralysis, bowel ischemia, and procedural blood loss of greater than 1 liter.

Full Information

First Posted
January 28, 2014
Last Updated
May 11, 2023
Sponsor
Andres Schanzer
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1. Study Identification

Unique Protocol Identification Number
NCT02050113
Brief Title
Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices
Acronym
CARPE-CMD
Official Title
Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2030 (Anticipated)
Study Completion Date
March 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andres Schanzer

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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, thoracoabdominal aneurysms and aortic arch 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. An additional amendment to the study allows the use of a custom made device to treat an aneurysm in the aortic arch.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complex Aortic Aneurysms, Thoracoabdominal Aneurysms, Pararenal Aneurysms, Juxtarenal Aneurysms, Marfan Syndrome, Ehlers-Danlos Syndrome, Loeys-Dietz Syndrome, Aortic Arch Aneurysm
Keywords
Complex Aortic Aneurysms, Thoracoabdominal Aneurysms, Pararenal Aortic Aneurysms, Juxtarenal Renal Aneurysms, Endovascular Branch Graft, Fenestrated Stent Graft, Abdominal Aortic Aneurysm, Endovascular, Aortic Dissection, Aortic Arch Aneurysms

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endovascular repair
Arm Type
Experimental
Arm Description
Endovascular repair of Complex Aortic Aneurysm using a physician modified stent graft. custom made device or arch branch device.
Intervention Type
Device
Intervention Name(s)
Custom Made Fenestrated or Branched Stent Graft
Other Intervention Name(s)
t-Branch Device, Physician Modified Device, Arch Branch Device
Intervention Description
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. If the aneurysm is in the aortic arch stents may be placed in the carotid and subclavian arteries. This surgery is done through small incisions in the groin and sometimes in the upper arm.
Primary Outcome Measure Information:
Title
The effectiveness of physician modified endovascular grafts will be determined by evaluating the proportion of patients that achieve Treatment Success
Description
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.
Time Frame
12 months post procedure
Secondary Outcome Measure Information:
Title
Incidence of Major Adverse Events
Description
Major adverse events include death, myocardial infarction, stroke, respiratory failure, paralysis, bowel ischemia, and procedural blood loss of greater than 1 liter.
Time Frame
Within 30 days of the initial procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A patient may be suitable for inclusion in the study if the patient has at least one of the following: Aortic or aortoiliac aneurysm with diameter ≥5.5 cm 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 Cannot be treated with a currently available non-modified approved device Symptomatic on presentation and unsafe to wait for the time necessary to obtain a currently available non-modified approved device At least 18 years of age Not pregnant or breastfeeding Willing and able to comply with five years of follow-up Willing and able to provide informed consent prior to enrollment No systemic or local infection that may increase the risk of endovascular graft infection 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 Cultural objection to receipt of blood or blood products Allergy or sensitivity to stainless steel, polyester, polypropylene, solder (tin, silver), gold, or nitinol Anaphylactic reaction to contrast that cannot be adequately pre-medicated Uncorrectable coagulopathy Unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina) Patient has active malignancy with life expectancy of less than 2 years Patient has life expectancy less than two years Anatomical Exclusion Criteria Significant occlusive disease, tortuosity, or calcification that would prevent endovascular access Proximal neck length ≤25 mm Proximal neck, measured outer wall to outer wall on a sectional image (CT) For use of Zenith Flex: diameter >32 mm or <18 mm For use of Zenith TX2: diameter >38 mm or <24 mm (for proximal and distal neck diameter) Proximal neck angulated more than 60 degrees relative to the long axis of the aneurysm Proximal neck diameter change over the length of the proximal seal zone >4 mm Proximal seal site with a circumferential thrombus/atheroma 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) Ipsilateral iliac artery fixation site diameter, measured inner wall on a sectional image (CT) >21 mm at distal fixation site Iliac artery distal fixation site <10 mm in length Non-bifurcated segment of any artery to be stented < 15 mm in length Artery to be stented with a maximum diameter <3 mm or >10 mm at the vessel ostium Inability to maintain at least one patent hypogastric artery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shauneen Valliere, MSN, NP
Phone
508-856-1767
Email
shauneen.valliere@umassmed.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Andres Schanzer, MD
Phone
508-856-5599
Email
andres.schanzer@umassmemorial.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andres Schanzer, MD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Memorial Health Care - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shauneen Valliere, MSN, NP
Phone
508-856-1767
Email
shauneen.valliere@umassmed.edu
First Name & Middle Initial & Last Name & Degree
Andres Schanzer, MD
Phone
508-856-5599
Email
andres.schanzer@umassmemorial.org
First Name & Middle Initial & Last Name & Degree
Andres Schanzer, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
32249045
Citation
Alqaim M, Cosar E, Crawford AS, Robichaud DI, Walz JM, Schanzer A, Simons JP. Lumbar drain complications in patients undergoing fenestrated or branched endovascular aortic aneurysm repair: Development of an institutional protocol for lumbar drain management. J Vasc Surg. 2020 Nov;72(5):1576-1583. doi: 10.1016/j.jvs.2020.02.013. Epub 2020 Apr 2.
Results Reference
derived
PubMed Identifier
25595400
Citation
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.
Results Reference
derived

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Complex Aortic Aneurysm Repair Using Physician Modified Endografts and Custom Made Devices

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