The purpose of this study is to evaluate Efficacy and Safety of a covered self-expandable dual-layered metallic mesh stent (UVENTA) in ureteral obstruction.
Prospective, Multi-center, open label, single arm Study 1. Treatment \- Covered self-expandable dual-layered metallic mesh Stents(cSEMS) are implanted in patents with malignant ureteral obstruction 2. Follow up * Assessments including X-ray(KUB), are done 3, 6, 12, 18 and 24 months after the procedure. * Diuretic RI scan (DTPA, MAG-3) 3, 6, 12 months after the procedure * Imaging such as IVP(Intravenous Pyelogram), ultrasonogram, CT(Computed Tomogram) are performed at 6 and 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Asan Medical Center
Seoul, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITINGPrimary patency rate
Rate of Ureter units maintaining patency without interventions after technical success of the primary procedure(Diuretic RI scan: T½ \< 20 min)
Time frame: 12 months
Technical success rate
Rate of technical success(each Ureter) resolving the stenosis and passing the contrast medium from the kidney to urinary bladder
Time frame: 1week, 1 month
Final patency rate
Rate of Ureter units maintaining patency without interventions aside from re-stenting(investigational device) after technical success of the primary procedure(Diuretic RI scan: T½ \< 20 min)
Time frame: 12 months
Adverse Event
Rate of total Adverse Events and Adverse Events relevant to Investigational Device
Time frame: 1week, 1, 3, 6, 9, 12 months
Predictive Risk Factors for Primary patency rate
Age, Sex, type of tumor(benign/malignant), length of stenosis, location of stenosis, UVJ cross, balloon catheterization, etc.
Time frame: 12 months
the primary patency rate among different location of distal stent
difference of the primary patency between the group of Distal stent located in urinary bladder and ureter
Time frame: 12 months
Ureteral stent symptom questionnaire(USSQ)
Comparative analysis of USSQ : before procedure and after procedure
Time frame: 1, 3, 6, 9, 12 months
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