Prospective Evaluation of Physician Modified Endografts for Aortic Disease

ConditionAortic Aneurysm

Trial statusNot yet recruiting

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 volunteers

Qualifiers

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
Device
A 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 group

Group A: Abdominal aortic aneurysm repairExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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 year

Secondary outcomes

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 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: