PROTECTOR: Evaluating the Safety and Effectiveness of the Protrieve Sheath in Preventing Clinically Significant Intraprocedural Pulmonary Embolism by Providing Embolic Protection in the IVC During Thrombectomy Procedures to Treat DVT
Status: Recruiting
Location: See all (15) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The Protrieve PROTECTOR Study is a prospective, single-arm, multicenter study of the Protrieve Sheath.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥ 18 years
• Planned intervention for DVT presenting with one or more of the following characteristics indicative of elevated risk for PE:
‣ Bilateral iliofemoral DVT
⁃ Clot extending into or located in the IVC
⁃ In-stent thrombosis
⁃ Presence of thrombosed IVC filter
⁃ Other features that the investigator deems put the subject at elevated risk for thromboembolism
• Willing and able to provide informed consent
Locations
United States
California
Hoag Hospital
RECRUITING
Newport Beach
Connecticut
Yale University
RECRUITING
New Haven
Florida
Baptist Health South Florida
RECRUITING
Miami
Indiana
IU Health Methodist Hospital
RECRUITING
Indianapolis
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Maryland
MedStar Union Memorial Hospital
RECRUITING
Baltimore
New Jersey
Englewood Hospital
RECRUITING
Englewood
Nevada
University Medical Center Southern Nevada
RECRUITING
Las Vegas
New York
NYU Langone Medical Center
RECRUITING
New York
Pennsylvania
Hospital of the University of Pennsylvania
RECRUITING
Philadelphia
Allegheny General Hospital
RECRUITING
Pittsburgh
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
University of Texas Medical Branch
RECRUITING
Galveston
University of Texas MD Anderson Cancer Center
RECRUITING
Houston
West Virginia
West Virginia University Hospital
RECRUITING
Morgantown
Contact Information
Primary
James Allen
james.allen2@stryker.com
6512798587
Backup
Chris Ottaviano
chris.ottaviano@stryker.com
6096344571
Time Frame
Start Date: 2025-03-05
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 60
Treatments
Experimental: Protrieve Sheath
The Protrieve Sheath is intended for embolic protection in the inferior vena cava (IVC) to prevent clinically significant intraprocedural pulmonary embolism during mechanical thrombectomy procedures in patients with high risk of embolization.
Related Therapeutic Areas
Sponsors
Leads: Inari Medical