Last updated: June 21, 2021
Sponsor: Rijnstate Hospital
Overall Status: Completed
Phase
N/A
Condition
Claudication
Vascular Diseases
Circulation Disorders
Treatment
N/AClinical Study ID
NCT04934501
2018-1206
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Scheduled endovascular treatment of a lesion in the SFA through placement of a baremetal or a covered stent
- A recently (<6 weeks) treated lesion in the SFA through placement of a bare metal or acovered stent
Exclusion
Exclusion Criteria:
- Hypersensitivity to the active substance(s) or any of the excipients in SonoVue
- Right-to-left cardiac shunt
- Severe pulmonary hypertension (pulmonary artery pressure > 90mmHg)
- Uncontrolled systemic hypertension
- Adult respiratory distress syndrome
- Severe pulmonary disease (e.g. COPD GOLD 3/4, adult respiratory distress syndrome)
- Clinically unstable cardiac disease (recent or ongoing myocardial infarction, unstableangina at rest, recent percutaneous coronary intervention, clinically worseningcardiac symptoms, severe cardiac arrythmia's, endocarditis, etc.)
- Prosthetic valves
- Loss of renal function (GFR < 31 ml/min), end-stage renal disease
- End-stage liver disease Sepsis
- Hypercoagulable status, recent thrombosis
- Congestive heart failure (class III or IV)
- Hypersensitivity to iodinated contrast media
- Pregnancy
Study Design
Total Participants: 20
Study Start date:
August 08, 2018
Estimated Completion Date:
August 30, 2019
Connect with a study center
Rijnstate Hospital
Arnhem, Gelderland
NetherlandsSite Not Available

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