Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT03891693
Eligibility Criteria:
Inclusion Criteria:
* Patient's age is above 21 and below 90
* Informed consent obtained
* Chronic background treatment with daily ASA
* Patients with significant Cephalic Arch Vein Stenosis or recurrent stenosis within 6 months of initial POBA diagnosed either clinically or with Duplex Ultrasound
* Post-angioplasty cephalic arch lumen size between 5mm - 7mm maximum diameter
Exclusion Criteria:
* Patients with significant central vein stenosis (\>70%) or total occlusion at time of angiographic study
* Cephalic arch stenosis \<50% stenosis or diameter \>5mm
* Patients with previous cephalic arch stenting (Bare Metal Stents or stent graft)
* Concomitant fistula inflow problem (e.g. juxta-anastomotic) that cannot be corrected optimally during the intervention (\>30% residual stenosis or angiographic lumen \<3mm)
* Patients with minor or major cephalic arch rupture during POBA procedure and the rupture point cannot be adequately sealed off during the procedure requiring a covered stent or open conversion
* Cephalic arch lesion length \<10mm or greater than 10cm
* Patients with uncontrolled hypertension
* Patient \<21 or \> 90 years of age.
* Pregnant women or women of childbearing potential who are not following an effective method of contraception.
* Contraindication to aspirin or clopidogrel usage
* Mental condition rendering the subject unable to understand the nature, scope, and possible consequences o the study, or language barrier such that the subject is unable to give informed consent.
* Uncooperative attitude or potential for non-compliance with the requirements of the protocol making study participation impractical
* Patients who do NOT have impaired renal function
* Occluded or thrombosed fistula
* Patients presenting with central venous stenosis
* Final angioplasty treatment requires a stent or DEB \>7mm in diameter
* Multiple lesions in the access circuit that cannot be treated with one stent and DEB.
* Vascular access circuit placed in the lower extremities
* Bare metal stent or stent-graft placed previously
* Metastatic caner or terminal medical condition
* Blood coagulation disorder
* Limited life expectancy (\<6 months)
* Sepsis or active infection
* Recent arm thrombophlebitis
* Allergy or other known contraindication to iodinated media contrast, heparin or paclitaxel
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
90 Years
Study:
NCT03891693
Study Brief:
Protocol Section:
NCT03891693