Efficacy and Safety of Fully Resorbable Sinus Drug-eluting Stents in Patients With Eosinophilic Chronic Rhinosinusitis With Nasal Polyps After Surgery: A Prospective, Randomized Controlled Trial

Exclusion Criteria

• •1. Previous nasal surgery within 6 months before screening that altered lateral wall structure and precludes polyp assessment.
• •2. Allergy to corticosteroids or any component of the fully degradable sinus drug-eluting stent.
• •3. Severe systemic disease contraindicating surgery.
• •4. Other significant nasal diseases (e.g., sinonasal tumor, fungal sinusitis).
• •5. Uncontrolled systemic diseases (e.g., severe cardiac, hepatic, renal dysfunction, diabetes).
• •6. Recent use of steroids (30-day washout for parenteral, 14-day for oral, budesonide drops/irrigation, nebulized), immunosuppressants/biologics (within 5 terminal half-lives), or leukotriene antagonists/modulators prior to baseline.
• •7. Recent acute sinusitis episode.
• •8. Physical obstruction preventing access to any ethmoid sinus for stent delivery.
• •9. Known history or diagnosis of glaucoma, ocular hypertension, or posterior subcapsular cataract.
• •10. Pregnant or lactating women.
• •11. Participation in another clinical trial within the past 1 month.
• •Part B
• •1. Postoperative polyp recurrence in ECRSwNP patients, with any side NPS \> 0.
• •2. Use of oral corticosteroids after the last FESS procedure.
• •3. Allergy to corticosteroids or any component of the fully degradable sinus drug-eluting stent.
• •4. Other significant nasal diseases (e.g., sinonasal tumor, fungal sinusitis).
• •5. Uncontrolled systemic diseases (e.g., severe cardiac, hepatic, renal dysfunction, diabetes).
• •6. Recent use of steroids (30-day washout for parenteral, 14-day for oral, budesonide drops/irrigation, nebulized), immunosuppressants/biologics (within 5 terminal half-lives), or leukotriene antagonists/modulators prior to baseline.
• •7. Recent acute sinusitis episode.
• •8. Physical obstruction preventing access to any ethmoid sinus for stent delivery.
• •9. Known history or diagnosis of glaucoma, ocular hypertension, or posterior subcapsular cataract.
• •10. Pregnant or lactating women.