The BRAVISSIMO trial wants to investigate in a controlled setting, the long-term (up to 24 months) outcome of the self-expanding nitinol Absolute Pro (Abbott Vascular) and the balloon-expandable Omnilink Elite (Abbott Vascular) stent in TASC A\&B and TASC C\&D iliac lesions. A separate analysis of both patient populations will be performed and listed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
325
Absolute Pro (Abbott Vascular) or Omnilink Elite (Abbott Vascular) stents
Universitair Ziekenhuis Antwerpen
Antwerp, Belgium
Imelda Hospital
Bonheiden, Belgium
AZ Sint-Blasius
Dendermonde, Belgium
ZOL Campus Sint-Jan
Genk, Belgium
University Hospital
Primary patency defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without TLR
Time frame: 12 months
Technical success, defined as the ability to achieve final residual angiographic stenosis no greater than 30%
Time frame: Procedure
Primary patency rate at different follow-up times defined as absence of hemodynamically significant stenosis at the target area on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without prior TLR.
Time frame: 1, 6 & 24 months
3) Clinical success at follow-up is defined as an improvement of Rutherford classification at different follow-ups of one class or more as compared to the pre-procedure Rutherford classification.
Time frame: 1, 6, 12 & 24 months
Serious adverse events
Time frame: 1, 6, 12, 24 months
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Ghent, Belgium