Drug Eluting Stents In The Critically Ischemic Lower Leg 2 (DESTINY 2)
The objective of this clinical evaluation is to evaluate the immediate and long term (up to 12 months) outcome of the XIENCE PRIME Everolimus Eluting Coronary Stent System (Abbott Vascular) in a controlled prospective investigation for the treatment of patients with critical limb ischemia due to the presence of lesions between 3cm and 10cm in length at the level of the below the knee arteries. Specifically the trial aims to illicit angiographic and ultrasound patency, clinical improvement, and adverse events associated with the use of this stent. The trial design is single armed, prospective, controlled trial run over 12 months of follow-up.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||a Prospective, Multicenter, Controlled Trial Evaluating the Implant of a Drug Eluting Stent (XIENCE PRIME, Abbott Vascular) in the Critically Ischemic Lower Leg|
- Primary patency at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]Absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography
- Technical success [ Time Frame: procedure ] [ Designated as safety issue: No ]The ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%
- Hemodynamic primary patency rate at 1, 6, 12-month follow-up [ Time Frame: 1, 6, 12-month follow-up ] [ Designated as safety issue: No ]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.
- Limb-salvage rate at all follow-up visits [ Time Frame: 1, 6, 12-month follow-up ] [ Designated as safety issue: No ]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).
- Primary assisted patency rate at 1, 6, 12-month follow-up [ Time Frame: 1, 6, 12-month follow-up ] [ Designated as safety issue: No ]Defined as flow through the treated lesion maintained by repeat percutaneous intervention completed prior to complete vessel closure.
- Secondary patency rate at 1, 6, 12-month follow-up [ Time Frame: 1, 6, 12-month follow-up ] [ Designated as safety issue: No ]Defined as flow through the treated lesion maintained by repeat percutaneous intervention after occlusion of the target lesion.
- Target lesion revascularization (TLR) at all follow-up visits [ Time Frame: 1, 6, 12-month follow-up ] [ Designated as safety issue: No ]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.
- Clinical success at all follow-up visits [ Time Frame: 1, 6, 12-month ] [ Designated as safety issue: No ]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.
- Serious adverse events until follow-up completions [ Time Frame: 1,6,12 months and interim visits ] [ Designated as safety issue: No ]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.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: Xience Prime stent
Patients with critical limb ischemia due to below the knee arterial lesion between 30 and 100mm in length, treated with the XIENCE PRIME™ Everolimus Eluting Coronary Stent System.
Implantation of one or more Everolimus-eluting XIENCE PRIME™ Everolimus Eluting Coronary Stent Systems.
Other Name: Xience Prime stent
The aim of this research is to evaluate the immediate and long term outcome of the XIENCE PRIME EverolimusEluting Coronary Stent System in a prospective investigation for the treatment of patients with critical limb ischemia due to the presence of lesions between 3cm and 10cm in length at the level of the below the knee arteries.
The research question is "Dose the use of an Everolimus coated stent in long tibial artery occlusions, between 3 and 10cm offer superior patency at 12 months compared to a historical cohort of bare metal stents in similar lesions?" Our hypothesis is that the use of everolimus coated stents in tibial artery occlusions between 3 and 10cm will result in lower binary restenosis than was historically found in equivalent but non-drugcoated bare metal stents.
Currently, there is evidence that angioplasty and drug eluting stents can be used as a therapy for patients with critical limb ischemia due to occlusive infrapopliteal disease. The XIENCE PRIME™ Everolimus Eluting Coronary Stent System (XIENCE PRIME EECSS or XIENCE PRIME stent system) is manufactured by Abbott. It is a device/drug combination product consisting of the CobaltChromium MULTILINK VISION 8 Coronary Stent System coated with a formulation containing everolimus, the active ingredient, embedded in a nonerodible polymer. The XIENCE PRIME Everolimus Eluting Coronary Stent is coated with everolimus (active ingredient), embedded in a nonerodible polymer (inactive ingredient). Everolimus is the active pharmaceutical ingredient in the XIENCE PRIME stent. It is a novel semisynthetic macrolide immunosuppressant, synthesized by chemical modification of rapamycin (sirolimus). The everolimus chemical name is 40O(2hydroxyethyl) rapamycin.
The XIENCE PRIME stent contains inactive ingredients including poly n-butyl methacrylate (PBMA), a polymer that adheres to the stent and drug coating, and PVDFHFP, which is comprised of vinylidene fluoride and hexafluoropropylene monomers as the drug matrix layer containing everolimus. PBMA is a homopolymer with a molecular weight (Mw) of 264,000 to 376,000 dalton. PVDFHFP is a nonerodible semicrystalline random copolymer with a molecular weight (Mw) of 254,000 to 293,000 dalton. The drug matrix copolymer is mixed with everolimus (83%/17% w/w polymer/everolimus ratio) and applied to the entire PBMA coated stent surface. The drug load is 100 μg/cm2 for all product sizes. No top-coat layer is used.
|Australia, New South Wales|
|Prince of Wales Private Hospital|
|Randwick, New South Wales, Australia, 2031|
|Bonheiden, Antwerp, Belgium, 2820|
|Department Vascular Surgery, A.Z. Sint-Blasius Hospital|
|Dendermonde, East-Flanders, Belgium, 9200|
|Herz-zentrum Bad Krozingen|
|Bad Krozingen, Germany, 79189|
|Leipzig, Germany, 04289|
|St Fransiskus hospital|
|Münster, Germany, 48145|
|Principal Investigator:||Marc Bosiers, MD||A.Z. Sint-Blasius Hospital|