The CHALLENGER Registry

Not yet recruitingOBSERVATIONAL
Enrollment

100

Participants

Timeline

Start Date

March 1, 2026

Primary Completion Date

March 1, 2028

Study Completion Date

March 1, 2028

Conditions
Chronic Subdural Hemorrhage (cSDH)
Interventions
DEVICE

Numen SILK coil embolization system

The Numen SILK coil embolization system is designed to be used in conjunction with the NumenFR detachment system. It consists of two main parts: • Introducer Sheath: The purpose of this sheath is to facilitate the introduction of the coil into the microcatheter. • Coil System: Composed of the pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion. The NumenFR detachment system is a sterile, handheld, single-patient use device designed for use with the Numen SILK coil embolization system and is operated by two pre-loaded batteries

Trial Locations (1)

10029

Icahn School of Medicine at Mount Sinai, New York

All Listed Sponsors
collaborator

MicroPort NeuroTech Co., Ltd.

INDUSTRY

lead

Icahn School of Medicine at Mount Sinai

OTHER

NCT07197840 - The CHALLENGER Registry | Biotech Hunter | Biotech Hunter