Physician Modified Endovascular Grafts for the Treatment of Juxtarenal Aortic Aneurysms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cleveland Clinic
About this trial
The primary objective of the clinical investigation "Physician Modified Endovascular Grafts for the Treatment of Elective, Symptomatic or Ruptured Juxtarenal Aortic Aneurysms" is to assess the use of the Physician-Modified Endovascular Grafts to repair juxtarenal aneurysms in high-risk subjects considered to be unsuitable candidates for open surgical repair, have limited or no other options for treatment, and having appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device:
* acutely (i.e., treatment success and technical success); * at 30 days (i.e., the rate of major adverse events (MAE)); and * at 6 months, 12 months and annually to 5 years (i.e., the proportion of treatment group subjects that achieve and maintain treatment success).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
An aneurysm with a maximum diameter of ≥ 5.5 cm for male (≥ 5.0 cm for female) or 2 times the normal diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
Disqualifiers
Patient has a mycotic aneurysm or has an active systemic or local infection that may increase the risk of endovascular infection
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, not related to the endovascular repair, planned within +/- 30 days of the AAA repair.
Patient has history of an aortopathic connective tissue disease (e.g. Marfan's or Ehler's-Danlos syndrome).
Trial design
Design model
Single group
Treatments tested in this trial
Implantation of Physician-Modified Terumo Aortic TREO abdominal stent graft system
DeviceA Physician Modified Endograft is a commercially available, off-the-shelf endograft that has been altered at the time of the procedure by creating fenestrations in the seal zone of the graft to preserve blood flow into vital branch vessels. These fenestrations are marked with medical grade gold markers to facilitate fluoroscopic visualization during the procedure. In order to prevent branch vessel occlusion, these branch vessels are typically stented with covered balloon expandable stents using standardized techniques.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Major Adverse Events
The proportion of patients that experience a rate of Major Adverse Events
Time frame
Up to 30 days2
Effectiveness
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 abdominal aortic aneurysm enlargement * Freedom from Aortic aneurysm rupture and conversion to open repair
Time frame
Up to 12 monthsSecondary outcomes
1
Occurrence of the safety events
* Mortality * Aneurysm related mortality * Aneurysm rupture * Major Adverse Events * Renal failure with or without permanent dialysis * Graft infection
Time frame
Up to 5 years2
Technical Success
Technical Success is a composite of the following: * Successful access to the arterial system using remote arterial exposure, percutaneous technique, or open surgical conduits * Successful delivery and deployment at the intended implantation site * Successful side branch catheterization and placement of bridging stents with restoration and maintenance of flow in all intended target vessels * Successful withdrawal of the delivery system * Patency of all endovascular graft and stent components * Absence of device deformations requiring unplanned placement of an additional device * Absence of Type I and III endoleaks at completion angiography
Time frame
Up to 30 days3
Stent Graft Migratoin
Occurrence of stent graft migration \>10 mm
Time frame
Up to 5 years4
All Endoleaks
Occurrence of endoleaks (all types, including Type I and III)
Time frame
Up to 5 yearsSponsors and contacts
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Source ClinicalTrials.gov