Overview

This trial was last updated 6 days ago.
Condition intracranial aneurysm
Treatments penumbra smart coiltm, penumbra coil 400tm (pc400), penumbra occlusion devicetm(pod)
Phase phase 4
Sponsor Penumbra Inc.
Start date June 2016
End date March 2019
Trial size 1000 participants
Trial identifier NCT02729740, CLP 10023

Summary

The primary objective of this study is to gather post market data on the Penumbra SMART Coil™ System in the treatment of intracranial aneurysms and other malformations.

Recruiting in the following locations…

United States Tennessee and Virginia
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Coil technology has evolved considerably since the initial introduction of the GDC coil over 25 years ago. In recent history, coil development has mostly focused on the delivery system, or pusher technology, and detachment. The new Penumbra SMART Coil not only addresses improvements in the delivery system, but importantly incorporates new technology into the actual coil implant itself. Penumbra SMART technology enables an individual coil to become progressively softer as it is deployed, utilizes advanced materials to improve stretch resistance, and incorporates new processes to create accurate complex and helical shapes.
penumbra smart coiltm
Current coils available to physicians have three principal levels of softness, Standard, Soft and Extra Soft. A conventional coil currently has only one level of softness, derived from using smaller platinum filaments than a Standard coil to make Soft and Extra Soft coils. The level of softness of the Penumbra SMART Coil is determined not only by the diameter of the platinum filament, but also by a proprietary structural element inside the coil. This unique development enables the Penumbra SMART Coil to become progressively softer along the length of a single individual coil as it is being deployed.
penumbra coil 400tm (pc400), penumbra occlusion devicetm(pod)
Other Penumbra Coils available as standard of care

Primary Outcomes

Measure
Ability to achieve adequate occlusion of the aneurysm sac by the SMART Coils
time frame: 1-2 hrs within the procedure
Number of times re-access with guidewire was required due to catheter kickout
time frame: 1-2 hrs within the procedure
Procedural device-related serious adverse events at immediate post-procedure
time frame: 1-2 hrs within the procedure
Retreatment at follow-up
time frame: One year from enrollment

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: Patients enrolled in this study must sign Informed Consent and be treated according to the cleared indications for the Smart, PC 400, and POD, which include the embolization of: - Intracranial aneurysms - Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae Exclusion Criteria: - Life expectancy less than one year - Smart, PC 400, or POD account for less than 75% of total number of coils opened - Participation in another clinical investigation that could confound the evaluation of the study device

Additional Information

Official title SMART - A Prospective, Multicenter Study Assessing the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil
Description This is a prospective, multi-center study of patients treated in accordance with the cleared indications for the Penumbra SMART CoilTM System (Smart), Penumbra Coil 400TM (PC 400), and Penumbra Occlusion DeviceTM (POD). Data for each patient are collected in accordance with the standard of care at each participating hospital through one-year follow-up. Approximately 1,000 patients with intracranial aneurysms or other malformations treated by the SMART CoilTM System at up to 100 centers will be enrolled. It is anticipated patient enrollment will take 3 years. All patients are to be assessed in accordance with the standard of care at each participating hospital through one year follow-up.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Penumbra Inc..