Health TrialsbyHealthPanel

Physician Modified Endovascular Grafts

ConditionAbdominal Aortic Aneurysms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington

About this trial

The primary objectives of this study are to determine whether physician modified endovascular grafts (PMEG) and specified company manufactured investigational devices are a safe and effective method of treating patients with elective, symptomatic or ruptured juxtarenal aortic aneurysms in those patients considered to 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

Disqualifiers

Patient has a mycotic aneurysm or has an active systemic 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 planned within +/- 30 days of the AAA repair.

Patient has history of connective tissue disease (e.g., Marfan's or Ehler's-Danlos syndrome).

Trial design

Design model

Single group

Treatments tested in this trial

  • Fenestrated Endovascular Graft or Company Manufactured Terumo Aortic Fenestrated TREO Endovascular Graft

    Device

    PMEG Fenestrated Device- Physician modified fenestrations for the bilateral renal arteries, celiac and SMA. May include several fenestrations or only one with or without the use of the Terumo Aortic TREOFit 3-D Printed Template for fenestration placement. Company Manufactured Device - Terumo Aortic Fenestrated TREO Abdominal Stent Graft System fenestrated for the bilateral renal arteries, celiac and SMA. May be in the straight or tapered configurations based on patient anatomical needs.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: PMEG Fenestrated Graft or Company Manufactured Terumo Aortic Fenestrated TREO GraftExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary Safety Endpoints

The safety of physician modified endovascular grafts will be determined by evaluating the proportion of patients that experience a rate of Major Adverse Events.

Time frame
Index Procedure through 12 Months
2

Primary Effectiveness Endpoint

The primary effectiveness endpoint is the proportion of treatment group subjects that achieve technical and treatment success.

Time frame
Index Procedure through 12 Months
3

Primary Technical Success Endpoint

Successful delivery and deployment of the investigational device with preservation of those branch vessels intended to be preserved at the study Index Procedure.

Time frame
Index Procedure
4

Primary Treatment Success Endpoint

All the following composite endpoint criteria to be met in order for a patient to be considered a treatment success: Technical Success, Freedom from Type I \& III endoleak, Freedom from stent graft migration \>10mm, Freedom from AAA enlargement \>5mm, Freedom from AAA rupture, Freedom from surgical conversion to open repair

Time frame
Index Procedure through 12 Months

Secondary outcomes

1

Secondary Safety Endpoint

The following secondary safety endpoints assessed are:, All-Cause Mortality, AAA Related Mortality, MAEs, AAA Rupture, Surgical Conversion to Open Repair.

Time frame
Index Procedure, 12 months, End of Study, Lifespan
2

Secondary Stent Graft Effectiveness Endpoint

Technical Success, Freedom from Type I \& III endoleaks, Freedom from stent graft migration, Freedom from AAA enlargement \>5mm.

Time frame
Index Procedure through Lifespan
3

Secondary Clinical Utility Assessment Endpoint(s)

Clinical Utility Assessment assessing overall Index Procedural items including Blood Loss, Length of Surgical Procedure, Intensive Care Unit Length of Stay, Length of Hospital Stay, and Length of Anesthesia

Time frame
Index Procedure

Other outcomes

Sponsors and contacts

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

University of Washington

Lead sponsor

Source ClinicalTrials.gov
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