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SFA TReatment and vAscular Functions

NCT03811925 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-01-22

No results posted yet for this study

Summary

Endovascular treatment of the superficial femoral artery has a high initial success rate, but restenosis occurs in up to 60% of cases. While restoration of tissue perfusion is achieved, interventional strategies affect endothelial function. Endothelial dysfunction is the pathophysiologic principle involved in the initiation and progression of arteriosclerosis.

The aim of this study is to determine the impact of endovascular strategies in the superficial femoral artery on local and systemic endothelial and vascular function.

Conditions

  • Peripheral Arterial Disease
  • Claudication, Intermittent

Interventions

PROCEDURE

Angioplasty and drug coated balloon of the superficial femoral artery (SFA)

In case of drug coated balloon (DCB) there should be always a predilation of the lesion with a predefined ballon (180 sec, Passeo-18). Thus, no direct DCB will be conducted. All DCB lengths (40mm to 200 mm) and Diameters (3mm to 7mm) are eligible for the Trial as long as used in the superficial femoral artery (SFA)

PROCEDURE

Angioplasty and stenting of the superficial femoral artery (SFA)

In case of stent application there should be always a predilation of the lesion with a predefined ballon (180 sec, Passeo-18). In case of stenting there should be a strong effect on vasomotion of the treated vessel area. All Stent lengths (40mm to 200 mm) and Diameters (5mm to 7mm) are eligible for the trial as long as used in the superficial femoral artery (SFA)

Sponsors & Collaborators

  • University Hospital, Essen

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-06-01
Primary Completion
2019-06-01
Completion
2019-07-01

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 NCT03811925 on ClinicalTrials.gov