Thirty-day freedom from MAE estimates were high across all groups: 99.2% in RC2,3, 96.1% in RC4,5, and 90.8% in RC6.
Successful revascularization was beneficial, with RC improvement noted across all groups. Key outcomes included quality of life (QoL) measures (VascuQol and EuroQol) and freedom from major adverse events (MAE), defined as death (within 30 days), major amputation, and target vessel revascularization based on Kaplan-Meier analysis.
#Eximo medical trial#
The LIBERTY trial ( identifier NCT01855412) is a prospective, observational, core laboratory-assessed, multicenter study of endovascular device intervention in 1204 subjects (mean age 69.8☑0.7 years 770 men) stratified by Rutherford category (RC): claudicants (RC2,3 n=501) and critical limb ischemia (CLI) with no/minimal tissue loss (RC4,5 n=603) or significant tissue loss (RC6 n=100). To report the 1-year results of a multicenter study of peripheral artery disease (PAD) treatment with a variety of endovascular treatment strategies employed in routine practice. (IN.PACT Global Clinical Study NCT01609296) The paclitaxel drug-coated balloon was safe and highly effective at 12 months after treatment of subjects with CTO ≥5 cm in the femoropopliteal arteries. There were no device- or procedure-related deaths through 30 days or major target limb amputations through 12 months. The primary safety composite endpoint was achieved by 88.7% of subjects. Provisional stenting was performed in 46.8% of lesions. Primary patency by Kaplan-Meier estimate was 85.3% through 12 months. The CTO imaging cohort had 126 subjects with 127 lesions (mean lesion length 22.83 ± 9.76 cm). The primary effectiveness endpoint was primary patency at 12 months, defined as freedom from clinically driven target lesion revascularization and freedom from restenosis. An independent Clinical Events Committee adjudicated all adverse events. The primary safety endpoint was a composite of freedom from device- and procedure-related mortality through 30 days, and freedom from major target limb amputation and target vessel revascularization through 12 months. The study contains prospectively defined cohorts with prospectively planned imaging analyses, including a CTO (≥5 cm) cohort in which subjects underwent duplex ultrasonography analyzed by an independent core laboratory. The IN.PACT Global Study is an international single-arm study that enrolled 1,535 patients with symptomatic femoropopliteal artery disease. This study evaluated the 12-month safety and effectiveness of a paclitaxel drug-coated balloon for treatment of intermittent claudication or rest pain in subjects with femoropopliteal chronic total occlusions (CTO).ĬTOs are difficult to treat, and the optimal intervention remains to be determined. The FLEX VP System provides safe plaque modification and vessel preparation via consistent, controlled-depth, circumferential micro-incisions in complex, mixed morphology lesions. This chapter describes FLEX VP’s mechanism of action and summarizes current clinical results in patients with peripheral arterial disease. FLEX VP is currently indicated for use with PTA catheters to facilitate dilation of stenoses in the femoral and popliteal arteries. The FLEX Vessel Prep™ (FLEX VP) System is a novel device designed to modify plaque, improve vessel compliance, and facilitate drug delivery by creating longitudinal, controlled-depth, circumferential micro-incisions along the entire length of a lesion using a retrograde pullback approach. Innovative methods for vessel preparation are specifically needed for long, complex lesions that may involve more time, additional equipment, and increased risk for long-term complications. To reduce acute procedural complications and optimize long-term clinical response, vessel preparation has become more common to modify plaque and increase luminal gain prior to PTA.
Percutaneous transluminal angioplasty (PTA) is the standard endovascular treatment for peripheral artery disease.
0 kommentar(er)
