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Vascular Effects Through Sirolimus vs. Paclitaxel DCB Implantation

NCT05450042 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-12-05

No results posted yet for this study

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.

Conditions

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

Interventions

DEVICE

SELUTION SLR DCB

Sirolimus DCB

DEVICE

Paclitaxel DCB

Paclitaxel DCB

Sponsors & Collaborators

  • University Hospital, Essen

    lead OTHER

Principal Investigators

  • Christos Rammos, Professor · University Hospital, Essen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-06
Primary Completion
2024-04-06
Completion
2024-04-06
FDA Device
Yes

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05450042 on ClinicalTrials.gov