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

Sponsor

University of Massachusetts, Worcester (Other)

Overall Status

Recruiting

CT.gov ID

NCT02050113

Collaborator

(none)

400

Enrollment

Location

Arm

192

Duration (Months)

2.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Complex Aortic Aneurysms Thoracoabdominal Aneurysms Pararenal Aneurysms Juxtarenal Aneurysms Marfan Syndrome Ehlers-Danlos Syndrome Loeys-Dietz Syndrome Aortic Arch Aneurysm	Device: Custom Made Fenestrated or Branched Stent Graft	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

N/A

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 :

Mar 1, 2014

Anticipated Primary Completion Date :

Mar 1, 2030

Anticipated Study Completion Date :

Mar 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endovascular repair Endovascular repair of Complex Aortic Aneurysm using a physician modified stent graft. custom made device or arch branch device.	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. 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. Other Names: t-Branch Device Physician Modified Device Arch Branch Device

Arm

Intervention/Treatment

Experimental: Endovascular repair

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

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. 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.

Other Names:

t-Branch Device

Physician Modified Device

Arch Branch Device

Outcome Measures

Primary Outcome Measures

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

Incidence of Major Adverse Events [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

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