Physician Modified Endovascular Grafts (PMEG)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of Washington
Sponsor:
Collaborator:
University of Washington
Information provided by (Responsible Party):
Benjamin W Starnes, University of Washington
ClinicalTrials.gov Identifier:
NCT01538056
First received: February 18, 2012
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Abdominal Aortic Aneurysms
Device: Fenestrated Endovascular Graft
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysm: An Investigator Initiated Study

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Safety [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    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. 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:
  • Effectiveness [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    • 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


Estimated Enrollment: 150
Study Start Date: March 2011
Estimated Study Completion Date: January 2022
Estimated Primary Completion Date: January 2020 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Fenestrated Endovascular Graft
    Modified endovascular graft with fenestrations to allow for blood flow to vital visceral vessels such as the renal arteries and SMA (Superior Mesenteric Artery).
    Other Name: FEVAR
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 is considered by the treating physician NOT to be a candidate for elective open surgical repair of the Juxtarenal AAA (i.e., category III or greater per American 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.
  5. Patient has a juxtarenal abdominal aortic aneurysm that meets at least one of the following:

    • Abdominal aortic aneurysm >5.0 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
  6. Patient has patent iliac or femoral arteries that will allow endovascular access with the physician modified endovascular graft.
  7. Patient has a suitable non-aneurysmal proximal aortic neck length of > 2 mm inferior to the most distal renal artery ostium.
  8. 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.
  9. 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.
  10. Patient has suitable non-aneurysmal distal common iliac diameters between 8 and 20 mm.
  11. Patient has juxtarenal aortic neck angulation < 60º
  12. Patient must be willing to comply with all required follow-up exam-

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01538056

Locations
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Billi Tatum, RN,CCRC    206-744-3369    btatum@uw.edu   
Principal Investigator: Benjamin W Starnes, MD         
Sponsors and Collaborators
Benjamin W Starnes
University of Washington
Investigators
Principal Investigator: Benjamin W Starnes, MD University of Washington
  More Information

No publications provided by University of Washington

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Benjamin W Starnes, Chief, Vascular Surgery, University of Washington
ClinicalTrials.gov Identifier: NCT01538056     History of Changes
Other Study ID Numbers: 39611
Study First Received: February 18, 2012
Last Updated: December 9, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Washington:
AAA

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on August 28, 2014