The objective of this study is to evaluate the performance of the In.Pact Admiral DEB for the treatment of popliteal lesions in comparison with literature results of stent treatment in popliteal lesions
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Imelda Hospital
Bonheiden, Antwerp, Belgium
RECRUITINGA.Z. Sint-Blasius
Dendermonde, East-Flanders, Belgium
RECRUITINGOLV Aalst
Aalst, Oost-Vlaanderen, Belgium
RECRUITINGPrimary Patency at 12 months
defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 12 months.
Time frame: 12 months
Technical success
defined as the ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30%.
Time frame: 1 day post-op
Primary Patency at 1 and 6-months
defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within the time of procedure and the given follow-up
Time frame: 1 and 6 months
Clinical success at 1, 6 and 12-months
defined as an improvement of Rutherford classification at 1-, 6- and 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification
Time frame: 1, 6 and 12 months
Serious Adverse Events
defined as a clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization
Time frame: up to 12 months
Survival rate
all-cause death ratio
Time frame: up to 12 months
Target Lesion Revascularization
defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the treated lesion edge
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RZ Heilig Hart Hospital
Tienen, Belgium
RECRUITINGTime frame: up to 12 months
Limb Salvage Rate
defined as absence of major amputation. Major amputation is defined as amputation at or above the ankle, as opposed to minor amputation, being an amputation at or below metatarsal level, preserving functionality of the foot)
Time frame: up to 12 months