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Completed

NCT Number: NCT02729740

Assessment of the Embolization of Neurovascular Lesions Using the Penumbra Smart Coil

The primary objective of this study is to gather post market data on the Penumbra SMART COIL® System (Smart System) in the treatment of intracranial aneurysms and other malformations.

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Key information

Conditions

Intracranial Aneurysm Aneurysm Arteriovenous Malformations Brain Diseases Cardiovascular Abnormalities Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Intracranial Arterial Diseases Nervous System Diseases Vascular Diseases Vascular Malformations

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal University, Saskatoon, Canada

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About this study

This is a prospective, multi-center registry of patients treated in accordance with the cleared indications for the Smart System (Smart), Penumbra Coil 400TM (PC 400), and Penumbra Occlusion Device (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 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients enrolled in this study must sign the Informed Consent Form 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 implanted
  • Participation in another clinical investigation that could confound the evaluation of the registry device

Treatment and study plan

Penumbra Smart Coil

Device

Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)

Device

Other Penumbra Coils available as standard of care

Primary outcomes

  1. Number of Participants Achieving Adequate Occlusion Immediate Post Procedure

    Time frame: Immediate Post Procedure

    Based on investigator's adjudication of adequate occlusion given anatomical and other considerations immediate post-procedure.

  2. Number of Times Re-access With Guidewire Was Required Due to Catheter Kickout

    Time frame: Immediate Post Procedure

    Re-access attempts due to catheter kick-out across all coils

  3. Number of Procedural Device-related Serious Adverse Events at Immediate Post-procedure

    Time frame: Immediate Post Procedure

  4. Number of Participants Requiring Retreatment Through Follow-up

    Time frame: One year from enrollment

Sponsors and collaborators

Lead sponsor

Penumbra Inc.

Industry

Registry information

Official study title

SMART - A Prospective, Multicenter Registry Assessing the Embolization of Neurovascular Lesions Using the Penumbra SMART COIL® System

Acronym: SMART

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 6, 2016
Registry last updated
Mar 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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