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Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil (SMART)

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ClinicalTrials.gov Identifier: NCT02729740
Recruitment Status : Active, not recruiting
First Posted : April 6, 2016
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Intracranial Aneurysm Device: Penumbra SMART CoilTM Device: Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD) Phase 4

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: SMART - A Prospective, Multicenter Study Assessing the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil
Study Start Date : June 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Penumbra SMART CoilTM System
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.
Device: 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.

Device: Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)
Other Penumbra Coils available as standard of care




Primary Outcome Measures :
  1. Ability to achieve adequate occlusion of the aneurysm sac by the SMART Coils [ Time Frame: 1-2 hrs within the procedure ]
    This a measure of the ability of the Smart Coils to occlude the aneurysm sac expressed as % occlusion of the volume.

  2. Number of times re-access with guidewire was required due to catheter kickout [ Time Frame: 1-2 hrs within the procedure ]
  3. Procedural device-related serious adverse events at immediate post-procedure [ Time Frame: 1-2 hrs within the procedure ]
  4. Retreatment at follow-up [ Time Frame: One year from enrollment ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729740


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Sponsors and Collaborators
Penumbra Inc.

Responsible Party: Penumbra Inc.
ClinicalTrials.gov Identifier: NCT02729740     History of Changes
Other Study ID Numbers: CLP 10023
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Penumbra Inc.:
Penumbra Smart coils
PC 400
AV malformations
AV fistulae

Additional relevant MeSH terms:
Aneurysm
Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases