Venous ThromboembolismPROTECTORNCT06495996
The Protrieve PROTECTOR Study
A study testing Percutaneous mechanical thrombectomy (PMT) in people with Venous Thromboembolism and Deep Venous Thrombosis, run by Inari Medical at 15 sites in United States.
Trial summary
The Protrieve PROTECTOR Study is a prospective, single-arm, multicenter study of the Protrieve Sheath. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Deep Venous Thrombosis
- What is being tested?
- Percutaneous mechanical thrombectomy (PMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 15 sitesUnited States
- Study dates
- 5 Mar 2025to 6 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current symptomatic PE
- Known anatomic inability to place Protrieve device via jugular vein access site
- Presence of clot extending to the IVC-Right Atrial junction or in the SVC
- Subject is pregnant
- Severe allergy to iodinated contrast agents that cannot be mitigated
- 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
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- 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
- Subject is participating in another study that may interfere with this study
- Subject has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the subject
- Subject has previously completed or withdrawn from this study
- Limb-threatening circulatory compromise (e.g., phlegmasia)
- Uncontrolled severe hypertension on repeated readings (systolic > 180mmHg or diastolic > 105mmHg)
- Severe allergy, hypersensitivity to, or thrombocytopenia from heparin
- Inability to provide therapeutic anticoagulation per Investigator discretion
- Known hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period
- Inability to be a candidate for intervention due to medical or technical reasons based on physician judgement
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
MedStar Union Memorial Hospital
Baltimore, Maryland, 21218
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Englewood Hospital
Englewood, New Jersey, 07631
University of Texas Medical Branch
Galveston, Texas, 77555
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
IU Health Methodist Hospital
Indianapolis, Indiana, 46204
University Medical Center Southern Nevada
Las Vegas, Nevada, 89102
Baptist Health South Florida
Miami, Florida, 33176
West Virginia University Hospital
Morgantown, West Virginia, 26506
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Yale University
New Haven, Connecticut, 06510
NYU Langone Medical Center
New York, New York, 10016
Hoag Hospital
Newport Beach, California, 92663
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
About this 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
The Protrieve PROTECTOR Study is a prospective, single-arm, multicenter study of the Protrieve Sheath.
Read the 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.
- Conditions
- Venous Thromboembolism, Deep Venous Thrombosis
- Being tested
- Percutaneous mechanical thrombectomy (PMT)
- Keywords
- Venous Thromboembolism, Deep Venous Thrombosis, Percutaneous Mechanical Thrombectomy
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous mechanical thrombectomy (PMT)Device
Percutaneous mechanical thrombectomy (PMT) is the endovascular removal of thrombus by catheter-based mechanical or aspiration methods. The term PMT generally describes interventional procedures performed without the use of lytic agents and frequently involves instrumentation in extensive amounts of fresh thrombus.
| Study group | Role | What they receive |
|---|---|---|
| Protrieve Sheath | Experimental | 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. Receives: Device: Percutaneous mechanical thrombectomy (PMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Effectiveness Measure:
- Clinically significant PE
Measured: 24 Hours (+-12 Hours)
Primary Safety Measure:
- Protrieve device-related Major Adverse Events (MAEs)
- Major Protrieve access site complications
Measured: 24 Hours (+-12 Hours)
Secondary outcomes (5)
Capture of Thromboembolic Material
- Capture and removal of thromboembolic material in the Protrieve funnel, as assessed by proportion of study cases where any material was either entrapped in the funnel or removed via Protrieve
Measured: 24 Hours (+-12 Hours)
Device Success
- Device success, defined as successful delivery, deployment, and retrieval of the Protrieve device without complications
Measured: 24 Hours (+-12 Hours)
Venous Access Routes
- Thrombectomy via supplementary venous access routes
Measured: 24 Hours (+-12 Hours)
Estimated Percentage of the Protrieve Funnel Obstructed
- Estimated percentage of the Protrieve funnel obstructed by clot, as observed by visual inspection or imaging
Measured: 24 Hours (+-12 Hours)
Blood Transfusions
- Blood transfusions associated with Protrieve Sheath access site bleeding
Measured: 24 Hours (+-12 Hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start5 Mar 2025
- Primary completion6 Nov 2025
- Study completion6 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inari Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ripal Gandhi, MD, Principal investigator, Baptist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06495996
- Sponsor's protocol ID
- 23-003
- Acronym
- PROTECTOR
- Status last verified
- Oct 2026
- First submitted
- 3 Jul 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06495996
- Acronym / sponsor ID
- PROTECTOR / 23-003
- Conditions
- Venous Thromboembolism, Deep Venous Thrombosis
- Keywords
- Venous Thromboembolism, Deep Venous Thrombosis, Percutaneous Mechanical Thrombectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Inari MedicalIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 6 Nov 2025 (actual)
- Study completion
- 6 Nov 2025 (actual)
- First posted
- 11 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Protrieve Sheath | Experimental | Device: Percutaneous mechanical thrombectomy (PMT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Planned intervention for DVT presenting with one or more of the following characteristics indicative of elevated risk for PE:
- Willing and able to provide informed consent
Key exclusion criteria (16 listed)
- Current symptomatic PE
- Known anatomic inability to place Protrieve device via jugular vein access site
- Presence of clot extending to the IVC-Right Atrial junction or in the SVC
- Subject is pregnant
- Severe allergy to iodinated contrast agents that cannot be mitigated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous mechanical thrombectomy (PMT)Percutaneous mechanical thrombectomy (PMT) is the endovascular removal of thrombus by catheter-based mechanical or aspiration methods. The term PMT generally describes interventional procedures performed without the use of lytic agents and frequently involves instrumentation in extensive amounts of fresh thrombus. | Device | Protrieve Sheath |
Primary outcome
Primary Effectiveness Measure:
Time frame: 24 Hours (+-12 Hours)
a. Clinically significant PE
Primary Safety Measure:
Time frame: 24 Hours (+-12 Hours)
1. Protrieve device-related Major Adverse Events (MAEs) 2. Major Protrieve access site complications
5 secondary outcomes
Capture of Thromboembolic Material
Time frame: 24 Hours (+-12 Hours)
Device Success
Time frame: 24 Hours (+-12 Hours)
Venous Access Routes
Time frame: 24 Hours (+-12 Hours)
Estimated Percentage of the Protrieve Funnel Obstructed
Time frame: 24 Hours (+-12 Hours)
Blood Transfusions
Time frame: 24 Hours (+-12 Hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ripal Gandhi, MD principal investigator
Baptist Hospital
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous mechanical thrombectomy (PMT) in people with Venous Thromboembolism and Deep Venous Thrombosis, run by Inari Medical at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Effectiveness Measure: (time frame: 24 Hours (+-12 Hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.