Comparing Fluoroscopy and Technological Methods for Guidance During Endovascular Procedures

Norwegian University of Science and Technology

Status and phase: Completed; Phase 1

Conditions: Aortic Aneurysm, Abdominal

Treatments: Device: Regular Fluoroscopy; Device: Technological Methods

Study type: Interventional

Funder types: Other

Identifiers

NCT00355940

STO-NTNU/DMF-SINTEF-1

Details and patient eligibility

About

The investigators want to test a navigation system for guidance during insertion of stent graft in abdominal aortic aneurysms. The navigation system consists of software developed by SINTEF Health, a custom made catheter with a micro position sensor in the tip and an emitter than induces an electromagnetic field around the patient. Preoperative CT- and intraoperative DynaCT- data are reconstructed into 3 dimensional images. The 3 dimensional images are loaded into the navigation system. Then the magnetic field, in which the patient finds himself, is calibrated with the 3 dimensional images. When the catheter is inserted into the iliac artery and aorta, the position sensor (in the tip of the catheter) is displayed in real time at the exact anatomic location in the 3 dimensional image.

Null hypothesis (H0):

• Insertion of stent graft is performed equally satisfactorily with fluoroscopy alone as with both fluoroscopy and new navigation technology

Alternative hypothesis (H2):

• Insertion of stent graft is NOT performed equally satisfactorily with fluoroscopy alone as with both fluoroscopy and new navigation technology

Enrollment: 17 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• AAA with diameter > 5,0 cm suitable for endovascular technique
• Normal creatinine
• > 60 years of age

Exclusion criteria

• Known heart failure or unstable coronary disease
• Other morbidity than normally contraindicates endovascular treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

17 participants in 2 patient groups

1

Experimental group

Treatment:

Device: Technological Methods

2

Active Comparator group

Treatment:

Device: Regular Fluoroscopy