Bleeding, Hemorrhage, Hypervascular Tumors
Conditions
Brief summary
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.
Interventions
DEVICEObsidio™ Conformable Embolic
Embolization with Obsidio™ Conformable Embolic.
Sponsors
Boston Scientific Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary effectiveness endpoint | Immediately following index procedure | 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. |
| Primary safety endpoint | 30 days following index procedure | 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. |
Countries
United States
Outcome results
None listed