Treatment of edge-stenosis in endografts, inserted for occlusive disease in the femoral superficial artery (SFA), with Drug Eluting Balloons (DEB).
- Conditions
- Stenosis and atherosclerosis in the endograft in the SFA1000318410003216
- Registration Number
- NL-OMON39003
- Lead Sponsor
- Rijnstate Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 23
Patients over 18 years of age
Signed informed consent
Edge stenosis of the endograft in the SFA with a peak systolic velocity ratio (PSV ratio) of >2.5
Target vessel diameter > or equal to 4 mm and < or equal to 7 mm
-Pregnancy or breast feeding women
-Known allergies or sensitivity to heparin, aspirin, other anticoagulant/antiplatelet therapies, -paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
-Patient unsuitable for administration of contrast agent
-Stroke or heart attack within 3 months prior to enrollment
-Enrolled in another investigational drug, device or biologic study
-Any surgical procedure or intervention performed within 30 days prior to or post index procedure
-Failure to successfully cross the target lesion
-Angiographic evidence of severe calcification
-Dementia or altered mental status that would prohibit giving conscious informed consent
-Need for adjunctive major surgical or vascular procedures within one month
-Untreated flow-limiting aortoiliac occlusive disease
-Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancies, dementia etc.) or other medical condition that would preclude compliance with study protocol
-Any previously known coagulation disorder, including hypercoagulability
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Patency rates after treatment with DEB (after 30-days and after 1 year) </p><br>
- Secondary Outcome Measures
Name Time Method <p>Complications </p><br>