The sirolimus-eluting bioresorbable peripheral scaffold system (Prava; Elixir Medical) is designed to treat stenoses and occlusion in the superficial femoral artery. Prava was first implanted in October 2016 and will be clinically evaluated in the DESappear trial that has currently enrolled 21 patients at 11 sites in Austria, Belgium, Germany and New Zealand.
The initial results were promising with only one target lesion revascularisation performed at the 12-month follow-up interval. The update was presented at CX yesterday by Andrew Holden (Auckland, New Zealand).
The DESappear (Drug Eluting Scaffold) study is a prospective, multicentre, single-arm safety and performance study. It plans to enrol 60 patients in Europe and New Zealand. The coordinating investigators are Marc Bosiers (Dendermonde, Belgium) and Dierk Scheinert (Leipzig, Germany). The key inclusion criteria are symptomatic claudication (Rutherford 2–4) and vessel diameter of ≥5mm to ≤6mm. The patients will be followed for clinical assessment and imaging using duplex ultrasound follow-up at 30 days, six months, one, two and three years.
The primary safety endpoint is a composite of freedom from perioperative death through 30 days and freedom from major adverse limb events defined as the occurrence of major amputation, thrombectomy or thrombolysis, or major open surgical revascularisation through six-month follow-up. The primary effectiveness endpoint is primary patency defined as freedom from restenosis (>50% diameter reduction defined by duplex ultrasound) or clinically-driven target lesion revascularisation through six months.
The drug-eluting scaffold is designed to treat stenosis and occlusions in the superficial femoral artery with clinical evaluation in the DESappear trial. The drug-eluting stent is a poly L-lactic acid-based polymer scaffold incorporating sirolimus (rapamycin) with around 17µg sirolimus per mm of scaffold length. Over four weeks, about 30% of the drug is eluted, with 90% of the drug eluted at six months. The scaffold degrades in six months with near complete resorption one year.
“The stent is made up of sinusoidal rings connected by “S” links for flexibility, is balloon expandable, has low recoil, radial strength and a single pattern for 5mm and 6mm scaffold diameters. It comes in 18, 37, 57mm scaffold lengths,” reported Holden
Holden was not able to provide substantial patency data at 12 months but noted that all the patients that have reached the follow-up are patent.
“It is very early days and there is limited trial data unfortunately but the data presented can show you the concept of a different bioabsorbable balloon-expandable scaffold for the superficial femoral artery segment with sirolimus elution,” said Holden. He continued, “The first implant was performed in October 2016 but it has been very slow to recruit because of the very restricted indications but 21 patients, so far, have been recruited.”
DESappear is a multicenter, single arm study with an initial enrollment target of up 60 patients. Patients are being recruited from11 centers in Austria, Belgium, Germ any and New Zealand. The primary safety endpoint is a composite of freedom from perioperative death through 30-days and freedom from major adverse limb events defined as the occurrence of major amputation, thrombectomy or thrombolysis, or major open surgical revascularization through 6 month follow up.
To date there have been 21 patients enrolled in the study. Initial results have been very promising with one target lesion revascularization (TLR) performed at the 12-month follow-up interval.