This is a single-arm, prospective, multi-center monitored trial recruiting patients with critical limb ischemia and with one or more lesions in the arteries below the knee. The immediate and long-term (up to 12 months) outcome of the PROMUS ELEMENT Everolimus-Eluting Stent System (Boston Scientific) and the PROMUS ELEMENT PLUS Everolimus-Eluting Stent System (Boston Scientific) will be evaluated. In 2 Belgian centers, 3 German centers and 1 New Zealand center a total of 70 patients will be recruited. Primary endpoint is primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
PROMUS ELEMENT Everolimus-Eluting Stent System (Boston Scientific) or PROMUS ELEMENT PLUS Everolimus-Eluting Stent System (Boston Scientific).
Imelda Hospital
Bonheiden, Antwerpen, Belgium
OLV Aalst
Aalst, Oost-Vlaanderen, Belgium
AZ Sint-Blasius
Dendermonde, Oost-Vlaanderen, Belgium
RZ Heilig Hart Tienen
Tienen, Belgium
Primary patency
Absence of restenosis (50% stenosis) or occlusion within the originally treated lesion based on angiography.
Time frame: 12 months
Technical success
The ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%.
Time frame: 1 day post-procedure
Hemodynamic primary patency rate
Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent at the given follow-up.
Time frame: 1, 6 and 12 month follow-up
Limb-salvage
Absence of major amputation, 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: 1, 6 and 12 month follow-up
Primary assisted patency rate
Defined as flow through the treated lesion maintained by repeat percutaneous intervention completed prior to complete vessel closure.
Time frame: 1, 6 and 12 month follow-up
Secondary patency rate
Defined as flow through the treated lesion maintained by repeat percutaneous intervention after occlusion of the target lesion.
Time frame: 1, 6 and 12 month follow-up
Target lesion revascularization (TLR)
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Herzzentrum Bad-Krözingen
Bad-Krözingen, Land Baden-Württemberg, Germany
St. Fransiskus Hospital
Münster, North Rhine-Westphalia, Germany
Herzzentrum Leipzig
Leipzig, Saxony, Germany
Auckland City Hospital
Auckland, Auckland, New Zealand
Time frame: 1 day, 1 month, 6 month and 12 month follow-up
Clinical success at follow-up
Defined as an improvement of Rutherford classification at 1 day and 1, 6, 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
Time frame: 1 day, 1 month, 6 month and 12 month follow-up
Improvement of ankle-brachial index (ABI)
Defined as an increase of the ABI at 1 day and 1, 6, 12-month follow-up compared to baseline in subjects with compressible arteries and baseline ABI \<0.9.
Time frame: 1 day, 1 month, 6 month and 12 month follow-up
Serious Adverse Events (SAE)
Defined as any 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: 1 day, 1 month, 6 month and 12 month follow-up