Physician Modified Endovascular Grafts (PMEG)

  • STATUS
    Recruiting
  • End date
    Jan 4, 2035
  • participants needed
    300
  • sponsor
    University of Washington
Updated on 4 June 2022
aortic aneurysm

Summary

The primary objectives of this study are to determine whether physician modified endovascular grafts 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.

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.

Details
Condition Abdominal Aortic Aneurysms
Treatment Fenestrated Endovascular Graft
Clinical Study IdentifierNCT01538056
SponsorUniversity of Washington
Last Modified on4 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

All patients must meet all of the following inclusion criteria to be eligible for
enrollment into this study
Patient is > 18 years of age
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)
Patient or Legally Authorized Representative has signed an Institutional Review Board
(IRB) approved Informed Consent Form
Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the
Patient is considered by the treating physician NOT to be a candidate for elective
following
Abdominal aortic aneurysm >5.5 cm in diameter
open surgical repair of the Juxtarenal AAA (i.e., category III or greater per American
Aneurysm has increased in size by 0.5 cm in last 6 months
Society of Anesthesiology (ASA) classification; please refer to Appendix III: ASA
Classification System). ASA category IV patients may be enrolled provided their life
expectancy is greater than 1 year
Patient has suitable non-aneurysmal distal common iliac diameters between 8 and 20 mm
Maximum diameter of aneurysm exceeds 1.5 times the transverse dimension of an
adjacent non-aneurysmal aortic segment
Patient must be willing to comply with all required follow-up exam-
Patient has patent iliac or femoral arteries that will allow endovascular access with
the physician modified endovascular graft
Patient has a suitable non-aneurysmal proximal aortic neck length of > 2 mm inferior
to the most distal renal artery ostium
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
Patient has a suitable non-aneurysmal proximal aortic neck diameter between 20 and
mm, averaged across the diameters at the Celiac, SMA, at the lowest patent renal
artery and at the midpoint of the renal arteries
Patient has juxtarenal aortic neck angulation < 60º

Exclusion Criteria

Patient has a mycotic aneurysm or has an active systemic infection
Patient has a known allergy or intolerance stainless steel or gold
Patient has a body habitus that would inhibit X-ray visualization of the aorta
Patient has a limited life expectancy of less than 1 year
Patients that meet ANY of the following are not eligible for enrollment into the study
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)
Patient has a major surgical or interventional procedure planned within +/- 30 days of
the AAA repair
Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos
syndrome)
Patient has a known hypersensitivity or contraindication to anticoagulation or
contrast media that is not amenable to pre-treatment
Patient is currently participating in another investigational device or drug clinical
trial
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
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