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COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device

Sponsor
Penumbra Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03464565
Collaborator
(none)
650
Enrollment
42
Locations
18.5
Actual Duration (Months)
15.5
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this registry is to collect performance and safety data on the Penumbra System including the 3D Revascularization Device in a real world patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).

Condition or Disease Intervention/Treatment Phase
  • Device: Penumbra System

Detailed Description

Registry Objective: The primary objective of this registry is to collect real-world performance and safety data on Penumbra System including the 3D Revascularization Device in a patient population with acute ischemic stroke (AIS) secondary to intracranial large vessel occlusion (LVO).

Registry Design: This will be a prospective, single-arm, multi-center observational registry and will include patients that present with either anterior or posterior LVO who are eligible for mechanical thrombectomy using the Penumbra System.

Registry Duration: Subjects will be in the registry for approximately 90 days from enrollment to last follow-up.

Study Design

Study Type:
Observational
Actual Enrollment :
650 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
COMPLETE: International Acute Ischemic Stroke Registry With the Penumbra System Aspiration Including the 3D Revascularization Device
Actual Study Start Date :
Jul 2, 2018
Actual Primary Completion Date :
Jan 17, 2020
Actual Study Completion Date :
Jan 17, 2020

Arms and Interventions

Arm Intervention/Treatment
Patients with acute ischemic stroke secondary to LVO

Device: Penumbra System
Penumbra System

Outcome Measures

Primary Outcome Measures

  1. mTICI Score [Post Procedure]

    Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a modified treatment in cerebral infarction (mTICI) score 2b or higher. mTICI scale ranges 0 to 3 higher values represent better outcomes.

  2. Functional Subject Outcome [90 days post]

    Functional subject outcome at 90 days post-procedure as defined by a modified Rankin Scale (mRS) 0-2. mRS scale ranges 0 to 6 higher values represent a worse outcome.

  3. All-cause mortality at 90 days [90 days]

    All-cause mortality at 90 days

Secondary Outcome Measures

  1. Incidence of device and procedure related Serious Adverse Events (SAEs) [Within 24 hours of procedure]

  2. Occurrence of embolization in previously uninvolved (or new) territories (ENT) [During Procedure]

    Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure

  3. Occurrence of symptomatic intracranial hemorrhages (sICH) [24 Hours Post Procedure]

  4. Time to Revascularization [During Procedure]

  5. Length of hospital stay [Through discharge, up to study completion at approximately 90 days]

  6. Discharge Facility [Through discharge, up to study completion at approximately 90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Patient age ≥ 18

  • Pre-stroke mRS 0-1

  • Patient experiencing acute ischemic stroke secondary to intracranial large vessel occlusion who are eligible for mechanical thrombectomy using the Penumbra System

  • Planned frontline treatment with Penumbra System

  • Signed informed consent per Institution Review Board/Ethics Committee

Exclusion Criteria:

  • Any comorbid disease or condition expected to compromise survival or ability to complete follow-up assessments through 90 days.

  • Currently participating in an investigational (drug, device, etc) clinical trial that will confound study endpoints. Patients in observational, natural history, and/or epidemiological studies not involving intervention are eligible.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Banner Desert Medical Center Mesa Arizona United States 85202
2 Eden Medical Center Castro Valley California United States 94546
3 St. Jude Medical Center Fullerton California United States 92835
4 Cedar Sinai Medical Center Los Angeles California United States 90048
5 Mercy San Juan Medical Center Sacramento California United States 95608
6 Los Robles Hospital Thousand Oaks California United States 91360
7 RIA Englewood Colorado United States 80112
8 Yale New Haven Hospital New Haven Connecticut United States 06519
9 Jackson Memorial Hospital Miami Florida United States 33136
10 Naples Community Hospital Naples Florida United States 34102
11 AdventHealth Orlando Orlando Florida United States 32803
12 University of Kansas Medical Center Kansas City Kansas United States 66106
13 Oschner Medical Center New Orleans Louisiana United States 70121
14 Brigham & Women's Hospital Boston Massachusetts United States 02115
15 SSM St. Clare Healthcare Saint Louis Missouri United States 63026
16 The Valley Hospital Ridgewood New Jersey United States 07450
17 Northwell Health Manhasset New York United States 11042
18 Mount Sinai New York New York New York United States 10029
19 NYU Langone Hospital-Brooklyn New York New York United States 11220
20 Mercy St. Vincent Medical Center Toledo Ohio United States 43608
21 Thomas Jefferson University Hospital Philadelphia Pennsylvania United States 19107
22 Palmetto Health Richland Hospital Columbia South Carolina United States 29203
23 Erlanger Health System Chattanooga Tennessee United States 37403
24 Fort Sanders Regional Medical Center Knoxville Tennessee United States 37916
25 Methodist University Hospital Memphis Tennessee United States 38104
26 Valley Baptist Medical Center Harlingen Texas United States 78550
27 Houston Methodist Hospital Houston Texas United States 77030
28 McAllen Medical Center McAllen Texas United States 78503
29 Swedish Medical Center-Cherry Hill Seattle Washington United States 98122
30 CHU de Bordeaux - Hôpital Pellegrin Bordeaux France 33000
31 Foundation Ophthalmic Adolphe De Rothschild Paris France 75019
32 Charité - Universitätsmedizin Berlin Berlin Germany 10117
33 Klinikum Chemnitz gGmbH Chemnitz Germany 09116
34 Universitätsklinikum Erlangen Erlangen Germany 91054
35 Universitätsklinikum Schleswig-Holstein Campus Lübeck Lübeck Germany 23538
36 Universitätsklinikum Magdeburg A. ö. R. Magdeburg Germany 39120
37 Samodzielny Publiczny Szpital Kliniczny Lublin Poland 20 - 954
38 Davidovsky Moscow City Hospital №23 Moscow Russian Federation 109240
39 City Clinical Hospital No. 1 Moscow Russian Federation 119049
40 Multidisciplinary City Hospital №2 Saint Petersburg Russian Federation 194354
41 Hospital Universitari Vall d'Hebron Barcelona Spain 08035
42 Hospital Clínico Universitario Virgen de la Arrixaca Murcia Spain 30120

Sponsors and Collaborators

  • Penumbra Inc.

Investigators

  • Principal Investigator: Osama O Zaidat, MD, Mercy St. Vincent Medical Center
  • Principal Investigator: Johanna Fifi, MD, Mount Sinai Health System
  • Principal Investigator: Ameer E. Hassan, MD, McAllen Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT03464565
Other Study ID Numbers:
  • 12965
First Posted:
Mar 14, 2018
Last Update Posted:
Dec 22, 2020
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Penumbra Inc.
Large Vessel Occlusion
Acute Ischemic Stroke
Mechanical Thrombectomy
Penumbra System
3D Revascularization
Additional relevant MeSH terms:
Stroke
Ischemic Stroke
Ischemia

Study Results

No Results Posted as of Dec 22, 2020