Treatment of edge-stenosis in endografts, inserted for occlusive disease in the femoral superficial artery (SFA), with Drug Eluting Balloons (DEB). - ETUDE

Rijnstate Ziekenhuis0 个研究点目标入组 23 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•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

发起方

Rijnstate Ziekenhuis