NCT05450042

Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation

Scientific Proposal to Substantiate Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University Hospital, Essen · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.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.

Detailed 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.

Conditions

• Peripheral Arterial Disease
• Flow-mediated Dilation
• Drug Eluting Balloon
• Infrainguinal Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	SELUTION SLR DCB	Sirolimus DCB
DEVICE	Paclitaxel DCB	Paclitaxel DCB

Timeline

• Start date: 2022-04-06
• Primary completion: 2024-04-06
• Completion: 2024-04-06
• First posted: 2022-07-08
• Last updated: 2023-12-05

Locations

1 site across 1 country: Germany

Regulatory

• FDA-regulated device study