A monocenter, non-randomized study to evaluate the clinical relevance of arterial Stenosis to blood flow using a pressure measurement in the affected vessel with the Pressure Wire X from Abbott Vascular.
Not Applicable
- Conditions
- Peripheral artery diseaseI70.2Atherosclerosis of arteries of extremities
- Registration Number
- DRKS00022103
- Lead Sponsor
- Medizinische UniversitätsklinikKlinik für Innere Medizin IIIKardiologie, Angiologie und Pneumologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Indication for endovascular treatment of a symptomatic high
grade arterial stenosis in the SFA and PA
- Indication for endovascular treatment of a symptomatic high
grade stenosis in the iliac artery or below the knee and a
moderate stenosis in the SFA or PA
- Informed consent must be obtained
- Capability of the patient to grant his consent
Exclusion Criteria
- < 18 years of age
– In-stent restenosis
– pregnancy
– anatomy or lesions unsuitalbe for FFR / RFR wire
crossing
- subjects who are hemodynamically or clinically unstable
– estimated life expectancy < 2 years
- chronic obstructive lung disease
- intolerance of papaverine, adenosine
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint: binary outcome of moderate or severe stenosis at 1-month and sensitivity, specificity and ROC analysis of FFR and RFR for symptomatic patients with a moderate vs. severe stenosis in the SFA at 1-months follow up.
- Secondary Outcome Measures
Name Time Method <br>Secondary endpoint: safety of the procedure – dissection, occlusion, perforation, peripheral embolism; death, target limb major amputation, critical ischemia of the target limb, target lesion revascularization<br>