Safety Study for the Treatment of Abdominal Aortic Aneurysms (UNITE)

Duke Vascular

Status and phase

Terminated

Phase 2

Conditions

Abdominal Aortic Aneurysms

Treatments

Device: UniFit AAA Stent Graft

Study type

Interventional

Funder types

Industry

Identifiers

NCT00610090

LMV-AUI-P2-001

Details and patient eligibility

About

The primary study objective, at this time, is to follow out to 5 years post implant the safety of already enrolled subjects who were treated with the UniFit Aorto-uni-iliac (AUI) Endoluminal Stent Graft (the "study device") for the repair of abdominal aortic aneurysms (AAAs).

Full description

This is a phase II, single-arm, prospective study of the safety of the study device for the repair of AAAs.

The investigator will identify eligible patients and explain the study and study device placement procedure to each patient and/or any available family members. Patients who provide written informed consent will be evaluated for study eligibility within the time period identified under Duration of Treatment. Patients who are confirmed to be eligible, based on screening assessment findings, will be enrolled in the study.

After hospital discharge, patients will attend study center visits at 30 days, 6 months, and 1, 2, 3, 4, and 5 years post-procedure for follow-up evaluations.

Enrollment

71 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient is 18 years of age or older
Patient has a AAA that meets one of the following criteria:
1. Aneurysm diameter of greater than 4.5 cm, or less than 4.5 cm with rapid expansion
2. The aneurysm has a saccular configuration where potential for rupture is increased or has exhibited dissection with potential for rupture at, or compromised flow to, vital structures
The vessels immediately proximal and distal to the lesion are capable of accommodating the study device
The access artery diameter and profile of the artery are capable of study device delivery.
Patient has proximal and distal neck lengths of greater than or equal to 1.0 cm
Patient is willing and able to comply with the follow-up regime.
Patient has provided written informed consent.

Exclusion criteria

Patient has an aortic diameter greater than 36 mm.
Patients with ASA score less than 3 and deemed low risk by the Investigator for open surgical repair.
Patient has an indispensable inferior mesenteric artery.
Patient has a distal landing zone of < 2 cm in length or > 16 mm in diameter
Patient has iliac arteries whose tortuosity prevents passage of the introducer catheter.
If female, patient is pregnant
Patient has a life expectancy less than two years.
Patient has an allergy to any of the study device materials
Patient has coagulopathy or bleeding disorders
Patient for whom contrast medium or anticoagulation drugs are contraindicated
Patient has an uncontained rupture of the aneurysm.
Patient has an active systemic or localized groin infection
Patient has a connective tissue disease.
Patient has a GFR < 30 ml/min/1.73m2
Patient has a circumferential mural thrombus at the implantation site.
Patient is a candidate for a bifurcated endovascular graft.
Patient has an aortic trunk with an angle greater than 90°.