Trials / Unknown
UnknownNCT03811925
SFA TReatment and vAscular Functions
Local and Systemic Vascular Function Following Drug Coated Balloon vs. Stenting in the Superficial Femoral Artery
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- University Hospital, Essen · Academic / Other
- Sex
- All
- Age
- 40 Years – 85 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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) |
Timeline
- Start date
- 2018-06-01
- Primary completion
- 2019-06-01
- Completion
- 2019-07-01
- First posted
- 2019-01-22
- Last updated
- 2019-01-22
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03811925. Inclusion in this directory is not an endorsement.