NCT01442636

Drug Eluting Stents In The Critically Ischemic Lower Leg 2

a Prospective, Multicenter, Controlled Trial Evaluating the Implant of a Drug Eluting Stent (XIENCE PRIME, Abbott Vascular) in the Critically Ischemic Lower Leg

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Flanders Medical Research Program · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	stent	Implantation of one or more Everolimus-eluting XIENCE PRIME™ Everolimus Eluting Coronary Stent Systems.

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-11-01
• Completion: 2014-11-01
• First posted: 2011-09-28
• Last updated: 2015-03-09

Locations

6 sites across 3 countries: Australia, Belgium, Germany