Percutaneous Mechanical Thrombectomy for Deep Vein Thrombosis

(PROTECTOR Trial)

Recruiting at 16 trial locations

Overseen By James Allen

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Inari Medical

Must not be taking: Heparin

Disqualifiers: Pregnancy, Severe hypertension, Renal impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new device called the Protrieve Sheath, designed to protect against dangerous blood clots in the lungs during deep vein thrombosis (DVT) procedures. It targets individuals with DVT at high risk for these clots, such as those with clots in both legs or in the main vein leading to the heart. Individuals advised by a doctor that their clots may cause complications might be suitable for this trial. This study could advance treatment options for managing DVT and preventing associated risks. As an unphased trial, it offers participants the chance to contribute to innovative research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on anticoagulation therapy, your INR (a blood test that measures how long it takes blood to clot) should be considered, and therapeutic anticoagulation must be possible according to the investigator's discretion.

What prior data suggests that the Protrieve Sheath is safe for embolic protection in the inferior vena cava?

Research has shown that the Protrieve Sheath is generally safe and well-tolerated by patients. In one study, 90% of patients experienced complete relief from swelling and pain after using it. Another study involving 17 patients who underwent vein procedures found success with the Protrieve Sheath and reported no major safety issues. These results suggest that the treatment is safe for individuals with deep vein problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Protrieve Sheath is unique because it offers embolic protection in the inferior vena cava (IVC) specifically during mechanical thrombectomy procedures. This is important because existing treatments for deep vein thrombosis, such as anticoagulants or traditional thrombectomy devices, do not specifically address the risk of pulmonary embolism during the procedure itself. By focusing on preventing embolization in real-time, the Protrieve Sheath could enhance the safety and effectiveness of mechanical thrombectomy, making researchers optimistic about its potential to improve patient outcomes.

What evidence suggests that the Protrieve Sheath is effective for preventing pulmonary embolism during mechanical thrombectomy?

Research has shown that the Protrieve Sheath, which participants in this trial will receive, effectively treats deep vein thrombosis (DVT). In earlier studies, 90% of patients experienced complete relief from swelling and pain. The sheath also prevented blood clots from moving during the procedure. Almost all patients achieved technical success, meaning the device worked as expected. Improvement in symptoms, known as clinical success, appeared in about 94% of patients. Overall, the Protrieve Sheath shows strong potential to help those with DVT. ^{1 2 5 6 7}

Who Is on the Research Team?

Sabah D Butty, MD

Principal Investigator

Indiana University Health Methodist Hospital

Are You a Good Fit for This Trial?

Adults over 18 with specific blood clot conditions like bilateral iliofemoral deep vein thrombosis, clots in the inferior vena cava (IVC), in-stent thrombosis, or a blocked IVC filter. Participants should be at high risk for blood clots traveling through the bloodstream and must consent to join.

Inclusion Criteria

Willing and able to provide informed consent

I am at high risk for blood clots in my lungs and need treatment.

Exclusion Criteria

My blood clotting and platelet levels are not within safe ranges for this trial.

Subject is pregnant

Subject is participating in another study that may interfere with this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo thrombectomy procedures using the Protrieve Sheath for embolic protection

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

24 hours

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Protrieve Sheath

Trial Overview The study is testing the Protrieve Sheath, a device used in percutaneous mechanical thrombectomy (PMT) to remove blood clots from within the heart's sac or arteries and veins without surgery.

How Is the Trial Designed?

Group I: Protrieve Sheath Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

Inari Medical

Lead Sponsor

Trials

18

Recruited

5,300+

Published Research Related to This Trial

The Trellis Thrombectomy System effectively removed 95% of thrombus in four patients with acute limb-threatening ischemia, demonstrating its efficacy in restoring blood flow.

There were no device-related complications reported, indicating that the Trellis device is a safe option for treating thrombosis in lower extremities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Trellis Thrombectomy System in the treatment of acute limb ischemia. Kasirajan, K., Ramaiah, VG., Diethrich, EB.[2017]

In a study of 25 patients with acute massive lower extremity deep venous thrombosis, percutaneous mechanical thrombectomy was found to be a safe and effective treatment, with no serious complications reported during hospitalization.

At 1-year follow-up, 88% of patients were asymptomatic within 24 hours, and there were no cases of recurrent deep venous thrombosis, indicating strong mid-term efficacy of the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous mechanical thrombectomy for acute massive lower extremity deep venous thrombosis. Shi, HJ., Huang, YH., Shen, T., et al.[2016]

In a study of 60 patients with proximal deep vein thrombosis, those who underwent percutaneous mechanical thrombectomy combined with long-term rivaroxaban treatment showed better outcomes, with 60% achieving partial recovery of vein lumen compared to 40% in the standard therapy group.

The thrombectomy group also experienced fewer severe venous outflow impairments (23.3%) compared to the standard therapy group (43.3%), indicating that this combined approach may enhance recovery and reduce complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Efficacy of percutaneous mechanical thrombectomy for proximal deep vein thrombosis]. Sukovatykh, BS., Sereditskiy, AV., Muradyan, VF., et al.[2022]

Catheter-directed thrombectomy using the FlowTriever system has shown promising results in treating patients with acute intermediate-high risk pulmonary embolism (PE), leading to rapid improvements in pulmonary artery pressure.

In three reported cases of submassive PE, immediate hemodynamic improvements were observed after successful mechanical thrombectomy, suggesting that this method could be a beneficial treatment option, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inari large-bore mechanical thrombectomy in intermediate-high risk submassive PE patients: Case series and literature review. Mathbout, MF., Hennawi, HA., Khedr, A., et al.[2022]

The Protrieve sheath was successfully used in a 39-year-old man with left-sided iliocaval DVT to prevent embolization during mechanical thrombectomy, demonstrating its potential to enhance safety in complex DVT treatments.

No complications occurred during the procedure, indicating that the Protrieve sheath effectively trapped and removed embolic material from the inferior vena cava, suggesting it could be a valuable tool in managing DVT cases that extend into the IVC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraprocedural Use of the Novel Protrieve Sheath Removes Embolus During Mechanical Thrombectomy of a Complex Iliocaval Deep Vein Thrombosis. Reynolds, KB.[2023]

Percutaneous thrombectomy (PT) is a safe and effective treatment for patients with intermediate- and high-risk pulmonary embolism (PE) who cannot receive thrombolytics, showing low in-hospital and 30-day mortality rates of 4% and 5%, respectively, based on a meta-analysis of 17 studies involving 455 patients.

The procedure significantly reduced pulmonary arterial pressures and improved heart function, with only a 4% incidence of major bleeding events, indicating that PT can be a viable option for patients at risk of bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous thrombectomy in patients with intermediate- and high-risk pulmonary embolism and contraindications to thrombolytics: a systematic review and meta-analysis. Milioglou, I., Farmakis, I., Wazirali, M., et al.[2023]

In a review of 8 cases of acute deep venous thrombosis treated with percutaneous mechanical thrombectomy, all patients achieved technical success with restored blood flow, indicating the procedure's effectiveness.

The treatment resulted in significant lysis of the thrombus, with only one patient experiencing mild post-thrombotic syndrome after six months, suggesting that the procedure is both safe and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Analysis of clinical therapeutic effect using percutaneous mechanical thrombectomy in the treatment of acute deep venous thrombosis]. Zhao, J., Zhao, K., Cao, Z., et al.[2018]

Mechanical thrombectomy using the Amplatz Thrombectomy Device was successful in recanalizing 83% of patients with proximal deep vein thrombosis (DVT), indicating its efficacy as a treatment option.

The procedure resulted in an average thrombus removal of 66%, with most patients experiencing minimal complications over a follow-up period of nearly 30 months, suggesting a favorable safety profile for this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical thrombectomy in patients with deep venous thrombosis. Delomez, M., Beregi, JP., Willoteaux, S., et al.[2019]

The FlowTriever System for percutaneous mechanical thrombectomy demonstrated significant effectiveness in improving right ventricular function in patients with acute intermediate-risk pulmonary embolism, with an average reduction in the RV/LV ratio of 0.38 (25.1%) within 48 hours post-procedure.

The procedure showed a favorable safety profile, with only 3.8% of patients experiencing major adverse events and a low incidence of major bleeding (1.0%), suggesting it may be a safer alternative to traditional thrombolysis methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Prospective, Single-Arm, Multicenter Trial of Catheter-Directed Mechanical Thrombectomy for Intermediate-Risk Acute Pulmonary Embolism: The FLARE Study. Tu, T., Toma, C., Tapson, VF., et al.[2020]

Aspiration thrombectomy using 9F or 10F catheters for acute lower extremity deep vein thrombosis (DVT) was found to be safe and effective, with a 100% clinical success rate and no procedure-related complications in a study of 68 patients.

The procedure resulted in significant symptom improvement and high patency rates at one year, with primary and secondary patency rates of 89.1% and 96.9%, respectively, indicating long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspiration thrombectomy using a large-size catheter for acute lower extremity deep vein thrombosis. Jia, Z., Tu, J., Zhao, J., et al.[2022]

Percutaneous mechanical thrombectomy (PMT) using the AngioJet device showed promising results in thrombus removal for patients with extensive deep venous thrombosis (DVT), with 24% achieving over 90% thrombus removal and 82% experiencing significant symptom improvement.

The procedure is considered minimally invasive and low-risk, with no complications directly related to the device, and it demonstrated good recurrence-free survival rates of 81.6% at 4 months and 51.8% at 11 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous AngioJet thrombectomy in the management of extensive deep venous thrombosis. Kasirajan, K., Gray, B., Ouriel, K.[2022]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S277268782500008X

Initial experience and early outcomes of treatment ... 90 % of patients had complete resolution of edema and pain. Conclusion. The initial single-center experience with the Protrieve sheath used in combination with ...

2. annalsofvascularsurgery.com annalsofvascularsurgery.com/article/S0890-5096(25)00458-3/pdf

Feasibility of the Protrieve Sheath for Embolic Protection ... The Protrieve Sheath demonstrated a high degree of effectiveness in managing embolic risk during venous thrombectomy, achieving technical and.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11479621/

Protrieve Sheath embolic protection during venous ... Outcomes. Technical success was achieved in all patients. Clinical success was achieved in 16 (94.1%) patients with improvement or resolution of ...

4. journals.sagepub.com journals.sagepub.com/doi/10.1177/00031348251341952

Early Experience Using Venous Sheath With Embolic ... Secondary outcomes included technical success, perioperative complications, and patency at 3 and 6 months. Results: Thirteen patients were ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0890509625004583

Feasibility of the Protrieve Sheath for Embolic Protection ... The Protrieve Sheath demonstrated a high degree of effectiveness in managing embolic risk during venous thrombectomy, achieving technical and clinical success ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06495996

NCT06495996 | The Protrieve PROTECTOR Study The primary study objective is to evaluate the safety and effectiveness of the Protrieve Sheath in preventing clinically significant intraprocedural pulmonary ...

7. journals.sagepub.com journals.sagepub.com/doi/full/10.1177/00031348251341952

Early Experience Using Venous Sheath With Embolic ... Secondary outcomes included technical success, perioperative complications, and patency at 3 and 6 months. Results: Thirteen patients were ...