OCCLUDE: Final Results from the Prospective Multicenter Real-World Study.

Authors

Ketan Y Shah, Gary Siskin, Abhishek Kumar, Ahmed Kamel Abdel Aal, Nariman Nezami, Vincent Wu, Christopher Grilli, Andrew C Gordon, Nima Kokabi, Alexander Ushinsky, Pavan Khanna, Abdul Sami Khan, Peter Park, Merve Ozen, Guy Johnson, Muneeb Ahmed, Kevin P Henseler, Kirema Garcia-Reyes, Ian Kozlowski, Abanti Sanyal, Amanda Smolock, Rahul S Patel

Published in

Journal of vascular and interventional radiology : JVIR. Pages 109189. Nov 12, 2026. Epub Nov 12, 2026.

Abstract

To evaluate the real-world effectiveness and safety of Obsidio Conformable Embolic for vascular embolization.
OCCLUDE is a multicenter, prospective, single-arm, real-world clinical registry. Patients (n=125) from 19 centers underwent embolization with Obsidio and were followed for 1 month. The primary effectiveness endpoint was technical success, defined as occlusion of target vessel(s), confirmed by angiography or visualization of an Obsidio cast on fluoroscopy/imaging immediately post-embolization. Clinical success, a secondary endpoint, was defined as absence of target vessel bleeding within 30 days. The primary safety endpoint was freedom from major adverse events (MAEs), defined as non-target embolization meeting serious adverse event criteria, unintended target organ/soft tissue infarction, vessel perforation/injury, or catheter entrapment through 30 days.
Indications included bleeding/hemorrhage (n=98; 78.4%), hypervascular tumor (HVT; n=19; 15.2%), and other (n=8; 6.4%). Median age was 63.0 years; 88.8% (n=111) had a single target embolized. Target arteries were renal (25.5%), non-gastrointestinal (GI) visceral (17.4%), upper GI (9.3%), extremity (3.7%), lower GI (2.5%), and other (41.6%). Among 161 embolized vessels, 38 (23.6%) received another embolic with Obsidio, with 84.2% used before Obsidio. Technical success was 100%. Clinical success was assessed in hemorrhage (n=98) and bleeding HVT (n=7) cases (n=105 total). Clinical success was 100% among 97/105 evaluable patients (0% rebleeding); 8 lacked 30-day follow-up. Freedom from MAEs was 97.4% (113/116), and no catheter entrapment occurred.
OCCLUDE demonstrated real-world safety and effectiveness of Obsidio, achieving 100% technical and clinical success, with a low MAE rate across diverse target vessels.

PMID:
43020462
Bibliographic data and abstract were imported from PubMed on 13 Nov 2026.

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