Prospective Evaluation of Physician Modified Endografts for Aortic Disease
ConditionAortic Aneurysm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorMayo Clinic
About this trial
The purpose of this research is to assess safety and preliminary effectiveness of the Physician-Modified Terumo Treo Abdominal Stent-Graft System.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
An aneurysm with a maximum diameter of >5.5cm in males and >5.0cm in females in diameter just proximal to the aneurysm using orthogonal (i.e., perpendicular to the centerline) measurements
Aneurysm with a history of growth > 0.5 cm in 6 months
Saccular aneurysm deemed at significant risk for rupture
Symptomatic aneurysm
Disqualifiers
Can be treated in accordance with the instructions for use with a legally marketed endovascular prosthesis
Is eligible for enrollment in a manufacturer-sponsored IDE at the investigational site
Unwilling to comply with the follow-up schedule
Inability or refusal to give informed consent by subject or legal representative
Trial design
Design model
Single group
Treatments tested in this trial
Physician-Modified Terumo Treo Abdominal Stent-Graft System
DeviceA physician modified Terumo Treo abdominal stent-graft system will be used during repair surgery for type II, III and IV thoracoabdominal aortic aneurysms.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Abdominal aortic aneurysm repairExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Proportion of study subjects with treatment success at 1 year
Treatment success is defined as freedom from the following: * Aneurysm enlargement: \>5mm as compared to any previous CT measure using orthogonal (i.e., perpendicular to the centerline) measurements. * Aneurysm rupture * Aneurysm-related mortality * Conversion to open repair * Secondary intervention for migration, Type I and III endoleaks, device integrity failure (e.g., fracture), and patency-related events (i.e., device component stenosis or occlusion and embolic events) * Graft infection * Disabling Stroke * Permanent dialysis Results are reported as a percentage
Time frame
1 yearSecondary outcomes
1
Proportion of procedures that achieve technical success
Technical success is defined as: * 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 that extends beyond 30 days by confirmatory imaging (CTA, MRA or duplex ultrasound) Results are reported as a percentage
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov