RECRUITING

Physician Modified Endovascular Grafts

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysm: an Investigator Initiated Study

Quick Facts

Study Start:2011-03

Study Completion:2035-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT01538056

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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-	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

Inclusion Criteria

Exclusion Criteria

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-

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

Contacts and Locations

Study Contact

Allison Larimore, MSN, RN

CONTACT

206-744-8257

alari@uw.edu

Principal Investigator

Benjamin W Starnes, MD

PRINCIPAL_INVESTIGATOR

University of Washington

Study Locations (Sites)

Harborview Medical Center

Seattle, Washington, 98104

United States

Collaborators and Investigators

Sponsor: University of Washington

Benjamin W Starnes, MD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2011-03

Study Completion Date2035-01

Study Record Updates

Study Start Date2011-03

Study Completion Date2035-01

Terms related to this study

Keywords Provided by Researchers

Additional Relevant MeSH Terms

Abdominal Aortic Aneurysms