Stenosis and atherosclerosis in the endograft in the SFA
Conditions
Interventions
An angioplasty of the lesion will be performed, according to the local
protocols. Afterwards the lesion will be treated with a paclitaxel-eluting
balloon .
Sponsors
Rijnstate Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: -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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patency rates after treatment with DEB (after 30-days and after 1 year) | — |
Secondary
| Measure | Time frame |
|---|---|
| Complications | — |
Countries
Netherlands
Outcome results
None listed