Investigation of Clot in Ischemic Stroke and Hematoma Evacuation

Ischemic Stroke Clinical Trial

— INSIGHT  

Official title:

Investigation of Clot in Ischemic Stroke and Hematoma Evacuation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04693767
• Other study ID #: CLP 15131
• Status: Active, not recruiting
• Start date: February 16, 2021
• Est. completion date: July 2023

Study information

• Verified date: December 2022
• Source: Penumbra Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study is to collect and analyze specimen from ischemic stroke patients undergoing thrombectomy procedures and from patients undergoing minimally invasive surgery for intracranial hematoma evacuation.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 400
• Est. completion date: July 2023
• Est. primary completion date: July 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 Years of Age
• Frontline treatment with: Penumbra System for ischemic stroke patients eligible for mechanical thrombectomy or Artemis Neuro Evacuation device for intracranial hematoma evacuation in patients eligible for minimally invasive surgery (MIS)
• Extracted thrombus/embolus
• Informed consent is obtained from either the patient or legally authorized representative (LAR)

Exclusion Criteria:

• Pregnancy or positive pregnancy test according to site routine practice (only required for women of child bearing potential; serum or urine acceptable)
• Currently participating in an investigational drug or device clinical trial that may confound the ability to capture clot and/or influence clot composition. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible

Related Conditions & MeSH terms

• Cerebral Infarction
• Hematoma
• Intracranial Hematoma
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Other:
• Mechanical thrombectomy
Clot specimen collection Extracranial blood collection
• Minimally invasive surgery
Clot specimen collection Arterial blood collection

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Miami Valley Hospital	Dayton	Ohio
United States	SSM St. Clare Healthcare	Fenton	Missouri
United States	Greenville Memorial / Prisma Health	Greenville	South Carolina
United States	University of Texas Health Center, Memorial Hermann Medical Center	Houston	Texas
United States	Indiana University Health Methodist Hospital	Indianapolis	Indiana
United States	St. Dominic Jackson Memorial Hospital	Jackson	Mississippi
United States	Baptist Medical Center	Jacksonville	Florida
United States	Fort Sanders Regional Medical Center	Knoxville	Tennessee
United States	University of Kentucky	Lexington	Kentucky
United States	Norton Neuroscience Institute	Louisville	Kentucky
United States	Methodist University	Memphis	Tennessee
United States	Banner Desert Medical Center	Mesa	Arizona
United States	Mount Sinai	New York	New York
United States	Christiana Care	Newark	Delaware
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Banner University Medical Center - Phoenix	Phoenix	Arizona
United States	MaineHealth	Portland	Maine
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Adventist Healthcare Shady Grove Medical Center	Rockville	Maryland
United States	Swedish Health Services, Swedish Cherry Hill	Seattle	Washington
United States	Stony Brook University	Stony Brook	New York
United States	Tacoma General Hosptial	Tacoma	Washington
United States	Westchester Medical Center	Valhalla	New York
United States	George Washington University	Washington	District of Columbia
United States	Metro Health	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clot specimen histology	Numbers of clot specimen for histology analysis	Clot specimen obtained during procedure
Primary	Blood and clot specimen transcriptomics	Numbers of blood and clot for RNA sequency	Blood and clot specimen obtained during procedure
Primary	Blood and clot specimen proteomics	Numbers of blood and clot specimen for proteomic analysis	Blood and clot specimen obtained during procedure
Primary	Blood and clot specimen genomics	Numbers of blood and clot specimen for single nucleotide polymorphisms (SNPs)	Blood and clot specimen obtained during procedure