Clinical trial NCT06495996: The Protrieve PROTECTOR Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Venous Thromboembolism
Deep Venous Thrombosis
Keywords: Venous Thromboembolism
Deep Venous Thrombosis
Percutaneous Mechanical Thrombectomy
Lead sponsor: Inari Medical
Sponsor class: INDUSTRY
First posted: 2024-07-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The Protrieve PROTECTOR Study is a prospective, single-arm, multicenter study of the Protrieve Sheath.

Detailed description: The primary study objective is to evaluate 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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Planned intervention for DVT presenting with one or more of the following characteristics indicative of elevated risk for PE:

   1. Bilateral iliofemoral DVT
   2. Clot extending into or located in the IVC
   3. In-stent thrombosis
   4. Presence of thrombosed IVC filter
   5. Other features that the investigator deems put the subject at elevated risk for thromboembolism
3. Willing and able to provide informed consent

Exclusion Criteria:

1. Current symptomatic PE
2. Known anatomic inability to place Protrieve device via jugular vein access site
3. Presence of clot extending to the IVC-Right Atrial junction or in the SVC
4. Subject is pregnant
5. Severe allergy to iodinated contrast agents that cannot be mitigated
6. INR \> 1.7 if not currently on anticoagulation therapy, platelets \< 50,000/μl which cannot be corrected prior to enrollment, or Hemoglobin \< 8.0 g/dL
7. Severe renal impairment in patients who are not yet on dialysis that in the Investigator's discretion would pose risk to the patient with the use of marketed contrast agents
8. Subject is participating in another study that may interfere with this study
9. Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject
10. Subject has previously completed or withdrawn from this study
11. Limb-threatening circulatory compromise (e.g., phlegmasia)
12. Uncontrolled severe hypertension on repeated readings (systolic \> 180mmHg or diastolic \> 105mmHg)
13. Severe allergy, hypersensitivity to, or thrombocytopenia from heparin
14. Inability to provide therapeutic anticoagulation per Investigator discretion
15. Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period
16. Inability to be a candidate for intervention due to medical or technical reasons based on physician judgement

Primary outcomes:
measure: Primary Effectiveness Measure:
timeFrame: 24 Hours (+-12 Hours)
measure: Primary Safety Measure:
timeFrame: 24 Hours (+-12 Hours)
Secondary outcomes:
measure: Capture of Thromboembolic Material
timeFrame: 24 Hours (+-12 Hours)
measure: Device Success
timeFrame: 24 Hours (+-12 Hours)
measure: Venous Access Routes
timeFrame: 24 Hours (+-12 Hours)
measure: Estimated Percentage of the Protrieve Funnel Obstructed
timeFrame: 24 Hours (+-12 Hours)
measure: Blood Transfusions
timeFrame: 24 Hours (+-12 Hours)
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Hoag Hospital
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Miami
country: United States
facility: Baptist Health South Florida
state: Florida
city: Indianapolis
country: United States
facility: IU Health Methodist Hospital
state: Indiana
city: Baltimore
country: United States
facility: MedStar Union Memorial Hospital
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Englewood
country: United States
facility: Englewood Hospital
state: New Jersey
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
city: Morgantown
country: United States
facility: West Virginia University Hospital
state: West Virginia
Study officials:
affiliation: Indiana University Health Methodist Hospital
name: Sabah D Butty, MD
role: PRINCIPAL_INVESTIGATOR
References: