Physician Modified Endovascular Grafts

Not Applicable

Recruiting

• Conditions: Abdominal Aortic Aneurysms
• Interventions: Device: Fenestrated Endovascular Graft

• Registration Number: NCT01538056
• Lead Sponsor: University of Washington

Brief Summary

The primary objectives of this study are to determine whether physician modified endovascular grafts (PMEG) and specified company manufactured devices (all to be referred throughout jointly as the investigational devices) are a safe and effective method of treating patients with elective, symptomatic or ruptured juxtarenal aortic aneurysms in those patients considered to be unsuitable candidates for open surgical repair and have limited or no other options for treatment. Secondary objectives include the validation of a patient-specific, 3-D printed aortic template as a surgical planning tool for fenestrated endografting.

Detailed Description

15,000 Americans die suddenly each year from rupture of an aneurysm in the aorta,which is the ninth leading cause of death in men over age 55. Aortic aneurysms are four times more common in men than in women and usually occur in those over age 50. Approximately one percent of men between the ages of 55 and 64 will have a significant aneurysm, and the likelihood increases to about four to six percent of those men over the age of 75. In a recent population-based study of Medicare beneficiaries, 83.2% of patients undergoing endovascular repair of their aortic aneurysm were male. Furthermore, 11.9% of patients were 67 to 69 years of age, 26.8% 70 to 74, 35.7% 75 to 79, 15.8% 80 to 84 and 9.8% \> 85 years of age. Ninety-six percent of patients were White, 3% Black and the rest either Hispanic or "Other". We have reason to believe that the current population of patients in the Pacific Northwest harboring abdominal aortic aneurysms match these statistics. Thus, women and minorities will definitely be under-represented in this study primarily due to the epidemiology of the disease process.

Our institution treats a large number of patients with aortic pathology including a large number of patients with symptomatic or ruptured abdominal aortic aneurysms. We recently published our results on the implementation of a protocol for managing these patients with endovascular techniques and have been able to reduce the mortality rate in half for the first time in over 30 years. Unfortunately, not all patients presenting with symptomatic or ruptured aortic aneurysms are candidates for endovascular repair. Reasons for exclusion predominantly involve lack of a suitable proximal aortic neck. Solutions to this problem involve multi-branched or "fenestrated" endografts which are being assessed in other clinical trials. However, grafts in these trials require between 6 and 12 weeks to manufacture and deliver to the investigational site.

On-site physician modification has also been described but is currently considered outside the Instructions For Use for the intended devices. Our institution's quality improvement department recently performed an objective review of 47 consecutive PMEG cases in patients presenting with asymptomatic, symptomatic or ruptured aortic aneurysms with highly encouraging results (See Many patients in our region do not have access to clinical trials involving emerging aortic endovascular therapies, and some have no other option due to urgent presentation or poor open surgical candidacy. For these important reasons, we seek to evaluate the safety and efficacy of PMEG using FDA-approved, off-the-shelf device in order to increase the applicability of these technologies to more patients and thus save more lives.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2012-02-18
• Study First Submitted QC: 2012-02-18
• Study First Posted: 2012-02-23
• Status Verified: 2023-11
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2030-01
• Study Completion: 2035-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

All patients must meet all of the following inclusion criteria to be eligible for enrollment into this study:

1. Patient is > 18 years of age

2. Patients who are male or non-pregnant female (females of child bearing potential must have a negative pregnancy test prior to enrollment into the study)

3. Patient or Legally Authorized Representative has signed an Institutional Review Board (IRB) approved Informed Consent Form

4. Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following:

   • Abdominal aortic aneurysm >5.5 cm in diameter
   • Aneurysm has increased in size by 0.5 cm in last 6 months.
   • Maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment

5. Patient has patent iliac or femoral arteries that will allow endovascular access with the physician modified endovascular graft.

6. Patient has a suitable non-aneurysmal proximal aortic neck length of > 2 mm inferior to the most distal renal artery ostium.

7. Patient has a suitable non-aneurysmal distal iliac artery length (seal zone) of >15 mm. The resultant repair should preserve patency in at least one hypogastric artery.

8. Patient has a suitable non-aneurysmal proximal aortic neck diameter between 20 and 32mm, averaged across the diameters at the Celiac, SMA, at the lowest patent renal artery and at the midpoint of the renal arteries.

9. Patient has suitable non-aneurysmal distal common iliac diameters between 8 and 20 mm.

10. Patient has juxtarenal aortic neck angulation < 60º

11. Patient must be willing to comply with all required follow-up exam-

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Exclusion Criteria

Patients that meet ANY of the following are not eligible for enrollment into the study:

1. Patient has a mycotic aneurysm or has an active systemic infection
2. Patient has unstable angina (defined as angina with a progressive increase in symptoms, new onset at rest or nocturnal angina, or onset of prolonged angina)
3. Patient has a major surgical or interventional procedure planned within +/- 30 days of the AAA repair.
4. Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).
5. Patient has a known hypersensitivity or contraindication to anticoagulation or contrast media that is not amenable to pre-treatment.
6. Patient has a known allergy or intolerance stainless steel or gold
7. Patient has a body habitus that would inhibit X-ray visualization of the aorta
8. Patient has a limited life expectancy of less than 1 year
9. Patient is currently participating in another investigational device or drug clinical trial
10. Patient has other medical, social or psychological conditions that, in the opinion of the investigator, preclude them from receiving the pre-treatment, required treatment, and post-treatment procedures and evaluations.
11. Subject is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fenestrated procedure	Fenestrated Endovascular Graft	Fenestrated device with fenestrations for bilateral renal ateries and SMA. May include all three fenestrations or only one

Primary Outcome Measures

Name	Time	Method
Safety and efficacy	30 days	The primary objectives of this study are to determine whether physician modified endovascular grafts (PMEG) and specified company manufactured devices are a safe and effective method of treating patients with elective, symptomatic or ruptured juxtarenal aortic aneurysms in those patients considered to be unsuitable candidates for open surgical repair and have no other options for treatment. The safety of physician modified endovascular grafts will be determined by evaluating the proportion of patients that experience a rate of Major Adverse Events. The Major Adverse Event rate will be compared to a performance goal.

Secondary Outcome Measures

Name	Time	Method
Effectiveness	12 months	* Technical Success, defined as successful delivery and deployment of the physician modified endovascular graft with preservation of those branch vessels intended to be preserved.; * Freedom from Type I \& III endoleaks; * Freedom from stent graft migration; * Freedom from AAA (Abdominal Aortic Aneurysm) enlargement

Trial Locations

Locations (1)

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States