Obsidio™ Conformable Embolic Registry

Boston Scientific Corporation125 enrolled

Overview

OCCLUDE is a prospective, post-approval, open-label, single arm, multi-center US registry of patients who undergo embolization with Obsidio™ Conformable Embolic. The purpose of this Registry is to assess effectiveness and safety outcomes of subjects who undergo embolization with Obsidio.

Study Type

OBSERVATIONAL

Enrollment

125

Conditions

Hypervascular Tumors Bleeding Hemorrhage

Interventions

Obsidio™ Conformable EmbolicDEVICE

Embolization with Obsidio™ Conformable Embolic.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is ≥ 18 years of age * Signed informed consent\* * Patient is to undergo or has undergone embolization with Obsidio™ Conformable Embolic * Patient is willing and able to comply with protocol requirements, including all procedures, clinical evaluations, and follow-up visits \*Patients being treated for control of bleeding/hemorrhage who are unable to consent prior to their procedure, can be enrolled if the informed consent is provided and signed within 72 hours of the index procedure Exclusion Criteria: * Patient has a life expectancy \< 30 days * Contraindications to receiving Obsidio™ Conformable Embolic per the Instructions For Use (IFU) * Embolization for uterine fibroids, prostate artery, genicular artery, ovarian vein, spermatic vein, pulmonary arteriovenous malformations, bronchial artery, asymptomatic benign tumors, portal vein, varices, lymphatic/thoracic duct, nonvascular channel (e.g. ureter, intestinal fistula) * Patients with more than 2 discrete lesions, defined as a treatment area that may be fed by one or more vessels

Locations (20)

Mayo Clinic Hospital

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Primary effectiveness endpoint

The primary effectiveness endpoint is technical success, which is defined as occlusion of the target vessel(s) after embolization with Obsidio™ Conformable Embolic as assessed via angiography or demonstration of a cast of Obsidio occluding the artery on fluoroscopy or image acquisition immediately following the index procedure.

Time frame: Immediately following index procedure

Primary safety endpoint

The primary safety endpoint is freedom from major adverse events defined as non-target embolization events that meet serious adverse event criteria, unintended target organ or soft tissue infarction, vessel perforation/injury and catheter entrapment through 30 days of the index procedure.

Time frame: 30 days following index procedure

Data from ClinicalTrials.gov

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