Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation

Status Recruiting

Clinical Trial Summary

Clinical Trial Description

Endovascular treatment of symptomatic atherosclerotic peripheral artery disease (PAD) is recommended as the primary revascularization strategy. Percutaneous transluminal angioplasty (PTA) of the superficial femoral artery has a high initial success rate, but restenosis and dissections frequently occur. While restoration of tissue perfusion is achieved, these interventional strategies affect vascular function, perpetuating dysfunctional vascular homeostasis. Vascular and endothelial dysfunction per se is the pathophysiologic principle involved in the initiation and progression of atherosclerosis and has been correlated to higher incidences of cardiac events such as myocardial infarction or the need for interventions. PTA and DCB treatment alter the endothelial homeostasis but the impact and detailed mechanisms are incompletely understood. The influence of the novel devices with improved hemodynamic capabilities with respect to vasomotion of the vessel wall, vascular function and vascular compliance can be measured by FMD (flow-mediated dilation), arterial stiffness indices and vascular strain analysis. The aim of this ITT is to determine the potential improvement and impact of the SELUTION SLR in the infrainguinal arteries on local vascular function. Device to be used are SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (n = 35) vs. Active comparator, Paclitaxel eluting balloon (Medtronic InPact, n = 35) The analysis of the primary end point will be performed on an intention-to-treat basis. Subgroup analyses will be performed according to PAD classification etiology and based on stent length. ;

Study Design

Related Conditions & MeSH terms

Drug Eluting Balloon
Flow-mediated Dilation
Infrainguinal Peripheral Arterial Disease
Peripheral Arterial Disease
Peripheral Vascular Diseases

Clinical Trial Details

NCT number	NCT05450042
Study type	Interventional
Source	University Hospital, Essen
Contact	Christos Rammos, Professor
Phone	0201-723-84808
Email	christos.rammos@uk-essen.de
Status	Recruiting
Phase	N/A
Start date	April 6, 2022
Completion date	April 6, 2024

View Details

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