EvaluatioN of Optilume Drug-Coated Balloon for the Endoscopic Treatment of UREteric Strictures

Exclusion Criteria28

• Treatment of the target ureter with incision or balloon dilation within 3 months of the study treatment
• Subjects with more than one ureteric stricture
• Subjects with target stricture in bifid or duplicated ureter
• Known sensitivity to paclitaxel or on medication that may have negative interaction with paclitaxel
• Ureteric stricture caused by extrinsic compression of the ureter
• Unable to endoscopically access target stricture for any reason
• Existing stones in the ipsilateral kidney or ureter (except for asymptomatic kidney stones) that are in close proximity to the target ureteric stricture
• Chronic renal failure treated with dialysis
• eGFR \<30 mL/min/1.73m2
• Kidney function ≤ 25% of split function on the side with target stricture as measured by functional renogram
• Kidney function ≤35% of split function on the side opposite target stricture as measured by functional renogram or other significant pathology or impairment that may impact renal function
• Life expectancy less than 12 months
• Women who are pregnant or breastfeeding
• Women of child-bearing potential planning to get pregnant in the next year or are unwilling to use contraception over the next 12 months
• Males unwilling to abstain or use protected sex for 30 days post treatment
• Males unwilling to use highly effective contraception for6 months post treatment if sexual partner(s) are of child-bearing potential
• Inability to provide legally effective informed consent
• Unwilling or unable to meet protocol follow-up requirements
• Participation in any interventional clinical investigation of a medical device, drug, or biologic (excluding registries) that may confound the results of the trial
• Active systemic or urinary tract infection
• Active malignancy in the abdomen or pelvis, or any malignancy considered considerable risk for metastasizing to the abdomen or pelvis over the next 12 months
• Uncontrolled diabetes defined as hemoglobin A1C ≥ 8% at baseline
• Unable to come off antiplatelet or anticoagulation medication prior to treatment to prevent bleeding complications at the discretion of the investigator
• Any other condition that may confound the results of the trial or presents an unacceptable risk for any study-related procedure
• Individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response
• Presence of any condition that precludes administration of furosemide during renograms
• Unable to tolerate contrast related to required study procedures or imaging.
• Additional Criteria for Pharmacokinetic Substudy Inclusion Ureteric stricture measurements appropriate for treatment with a 6mm (18F) or 8mm (24F) diameter Optilume DCB Exclusion Prior treatment with any device or medical therapy that contains paclitaxel, including drug coated balloons for vascular and urethral applications