Jotec, a fully owned subsidiary of CryoLife, has announced 30-day results of the PLIANT study, which was an observational, prospective, non-randomised, multicentre, international study conducted in 12 hospitals throughout Europe. This study enrolled 45 patients who were due to undergo implantation with the E-liac stent graft system.
One of the major anatomical challenges of endovascular aortic repair (EVAR) in patients with AAA are concomitant iliac artery aneurysms. Iliac artery aneurysms are known to exacerbate the complexity of EVAR and increase the incidence of type Ib endoleak, iliac limb occlusion and aneurysm rupture. The Jotec GmbH E-liac stent graft system was introduced to address these issues and is indicated for patients with aorto-iliac or isolated iliac aneurysms.
The purpose of the study was to examine the clinical and technical success of the E-liac side branched stent graft system when implanted in accordance with the IFU. Data was collected at pre-operative planning, intervention, prior to discharge, 30±15 days, 12±2 months and 36±2 months. All CT scans and final angiograms were analysed by a core lab.
The primary endpoint was aneurysm exclusion (no type I, III, IV endoleak) with primary patency of the IIA and EIA on the E-liac implantation side. This is equivalent to the definition of clinical and technical success. Technical success was assessed at 24 hours after the index procedure whereas clinical success was determined at follow up.
The peri-procedural primary patency rate of the IIA and EIA on the E-liac implantation side was 100%. Four patients had clinically relevant type Ia endoleak, three located in the infrarenal aorta and one in the CIA. Two type Ia endoleaks were related to mismatch diameters of the graft and the respective landing zones.
Thirty-day clinical success was achieved in 43/45 patients (96%) and three successful endovascular re-interventions were performed within 30-day follow-up. Primary patency at 30 days was 100% for the IIA and 98% for the EIA with 100% primary assisted patency in the latter.
The high clinical success rate, low number of re-interventions (2%) and excellent patency rate demonstrate the safety and feasibility of the E-liac Stent Graft System.