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Search / Trial NCT04106583

Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities

Launched by PENUMBRA INC. · Sep 25, 2019

Trial Information

Current as of June 23, 2025

Completed

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patient age ≥ 18 years
  • Patient having embolization of intracranial aneurysms
  • WAVE Extra Soft Coil is final finishing coil
  • Penumbra SMART COIL System accounts for at least 75% of total number of coils implanted
  • Informed consent obtained per Institutional Review Board/Ethics Committee (IRB/EC) requirements
  • Exclusion Criteria:
  • Life expectancy less than 1 year
  • Patient previously enrolled in the SURF Study
  • Known multiple intracranial aneurysms requiring treatment during index procedure
  • Patient is unwilling or unable to comply with protocol follow up schedule and/or based on the Investigator's judgment the patient is not a good study candidate
  • Participation in an interventional drug or device study that may confound the results of the study

About Penumbra Inc.

Penumbra Inc. is a leading medical technology company focused on developing innovative solutions for neurovascular and peripheral vascular conditions. With a commitment to advancing patient care, Penumbra specializes in the design and manufacture of devices that enhance the treatment of complex medical conditions, including stroke and embolism. The company leverages cutting-edge technology and rigorous clinical research to deliver products that improve outcomes and enhance the quality of life for patients. Penumbra's dedication to innovation and collaboration with healthcare professionals positions it at the forefront of the medical device industry.

Locations

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Chicago, Illinois, United States

Dallas, Texas, United States

Pittsburgh, Pennsylvania, United States

Newport News, Virginia, United States

Valhalla, New York, United States

Danville, Pennsylvania, United States

Toronto, Ontario, Canada

New York, New York, United States

Oklahoma City, Oklahoma, United States

Tampa, Florida, United States

Basel, , Switzerland

Oklahoma City, Oklahoma, United States

Greenville, North Carolina, United States

Tampa, Florida, United States

Greenville, South Carolina, United States

Charleston, South Carolina, United States

New Orleans, Louisiana, United States

Miami, Florida, United States

Manhasset, New York, United States

Philadelphia, Pennsylvania, United States

Toledo, Ohio, United States

Dresden, , Germany

Chemnitz, , Germany

Thousand Oaks, California, United States

Manhasset, New York, United States

Stony Brook, New York, United States

Indianapolis, Indiana, United States

Buffalo, New York, United States

Indianapolis, Indiana, United States

Chattanooga, Tennessee, United States

Lübeck, , Germany

Toronto, Ontario, Canada

Barcelona, , Spain

Lakewood, Colorado, United States

Wyoming, Michigan, United States

Mcallen, Texas, United States

Dothan, Alabama, United States

Phoenix, Arizona, United States

Tucson, Arizona, United States

La Mesa, California, United States

Englewood, Colorado, United States

New Haven, Connecticut, United States

Tampa, Florida, United States

Joliet, Illinois, United States

Bridgeton, Missouri, United States

Knoxville, Tennessee, United States

Plano, Texas, United States

Calgary, , Canada

Bremen, , Germany

Novara, , Italy

San Sebastián, , Spain

Englewood, Colorado, United States

Miami, Florida, United States

Plano, Texas, United States

Toronto, , Canada

Patients applied

0 patients applied

Trial Officials

Clemens M Schirmer, MD

Principal Investigator

Geisinger Clinic

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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