Viper Catheter System for Pulmonary Embolism

(ENGULF Trial)

Recruiting at 22 trial locations

Overseen By Debra Cogan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Endovascular Engineering

Must not be taking: Thrombolytics, Anticoagulants

Disqualifiers: Massive PE, Pulmonary hypertension, Heart failure, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 48 hours

181 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing the safety and feasibility of a new device called the Viper Catheter System, which is designed to remove blood clots from the lungs of patients with serious but not fully blocking clots. The device works by being inserted into the blood vessels and physically extracting the clots to help restore normal blood flow.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using thrombolytics (medications that dissolve blood clots), you must not have used them within 30 days before the trial.

What data supports the effectiveness of the Viper Catheter System treatment for pulmonary embolism?

The research highlights that catheter-based therapies, like the Viper Catheter System, are evolving and have been used effectively for treating pulmonary embolism by mechanically removing clots. Similar treatments, such as suction thrombectomy, have shown promise in managing acute pulmonary embolism, suggesting potential effectiveness for the Viper Catheter System. ^{1 2 3 4 5}

How does the Viper Catheter System treatment for pulmonary embolism differ from other treatments?

The Viper Catheter System is a catheter-based treatment for pulmonary embolism that likely involves mechanical thrombectomy, which removes clots without the need for thrombolytic drugs (medications that dissolve clots). This approach can reduce the risk of bleeding compared to traditional treatments that use these drugs. ^{1 4 5 6 7}

Research Team

Andrew Klein, MD

Principal Investigator

Piedmont Heart

Julie Bulman, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

This trial is for adults aged 22 to 90 with acute submassive pulmonary embolism, stable blood pressure and heart rate, and evidence of a blockage in the lung arteries. They must be able to consent and have not used certain blood thinners recently. Excluded are those with severe heart issues, recent major surgery or trauma, extreme obesity, or conditions affecting life expectancy.

Inclusion Criteria

My doctor agrees I am fit for the procedure.

RV/LV ratio of ≥ 0.9 (Enrollment qualification assessment based on Investigator's interpretation of RV/LV ratio at baseline)

Systolic blood pressure ≥ 90 mmHg (initial SBP may be ≥ 80 mmHg if the pressure recovers to ≥ 90 mmHg with fluids)

Exclusion Criteria

I need oxygen because of a lung condition.

My doctor thinks I have less than a year to live because of my advanced cancer.

I was diagnosed with a severe pulmonary embolism.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo thrombectomy using the Hēlo PE Thrombectomy System for acute submassive pulmonary embolism

48 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on RV/LV ratio reduction and adverse events

48 hours

Long-term follow-up

Participants may be monitored for additional safety and effectiveness outcomes beyond the initial follow-up period

4 weeks

Treatment Details

Interventions

• Viper Catheter System

Trial Overview The study tests the Viper Catheter System's safety and feasibility for removing clots from lung arteries in patients with a type of lung blockage called acute submassive pulmonary embolism. It's an initial evaluation using this novel device on eligible participants.

Participant Groups

Group I: Investigational Device Experimental Treatment 1 Intervention

The study design includes two cohorts: a Pre-Pivotal Cohort of up to 50 subjects (25 Feasibility and up to 25 Roll-Ins), and a Pivotal Cohort enrolling up to 131 subjects, to yield 100 evaluable subjects at 48 hours post procedure.

Viper Catheter System is already approved in United States for the following indications:

Approved in United States as Viper Catheter System for:

• Acute submassive pulmonary embolism

Who Is Running the Clinical Trial?

Endovascular Engineering

Lead Sponsor

Trials

1

Recruited

180+

Findings from Research

Aspiration catheters (like JETi®, Penumbra Indigo®, and Aspirex®) were found to be significantly more effective than standard fragmentation catheters in treating large-burden pulmonary embolism, achieving faster recanalization times and removing a greater percentage of thrombus (86.1% vs. 31.7%).

While all catheters were able to achieve some level of recanalization, the study demonstrated that aspiration techniques are superior for effectively clearing clots, with only minimal residual thrombus remaining in the pulmonary artery after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Aspiration Catheters with Modified Standard Catheters for Treatment of Large Pulmonary Embolism Using an In-vitro Patho-Physiological Model. Schubert, F., Tamura, M., Bezela, S., et al.[2022]

In a preclinical study using a porcine model, the React68 and React71 aspiration catheters demonstrated effective recanalization rates for treating large vessel occlusion (LVO), showing no significant difference compared to the ACE68 catheter.

Both React68 and React71 catheters exhibited a strong safety profile, with no physical or neurological deficits observed in treated animals, and minimal tissue disruption without signs of inflammation or significant damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy Evaluation of Aspiration Thrombectomy With Large Bore Catheters in a Porcine Model. Jankowitz, BT., Gross, BA., Mintz, E., et al.[2020]

Vacuum-assisted thrombectomy (VAT) using the AngioVac system was successfully performed on a patient with right heart thrombus (RHT) and acute pulmonary embolism (PE), demonstrating its potential as a treatment option for high-risk patients who cannot undergo surgery or thrombolysis.

Multidisciplinary collaboration, such as the Pulmonary Embolism Response Team (PERT) model, can enhance procedural success and improve patient outcomes in managing complex cases of PE and RHT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AngioVac aspiration of right atrial cardiac pacemaker lead-associated thrombus with concurrent PE under fluoroscopic and transesophageal echocardiographic guidance: a multidisciplinary collaboration for improved patient outcome. Yu, T., Yang, EH., Ranade, M.[2021]

Acute pulmonary embolism (PE) is a serious condition affecting over 100,000 people annually in the U.S., and while standard treatment involves anticoagulation, some patients require more advanced interventions due to severe symptoms.

Recent advancements in catheter-based therapies, such as catheter-directed thrombolysis and suction thrombectomy, offer targeted treatment options that can improve outcomes for patients with acute PE, emphasizing the importance of a multidisciplinary approach in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contemporary Management of Acute Pulmonary Embolism: Evolution of Catheter-based Therapy. Carlon, TA., Goldman, DT., Marinelli, BS., et al.[2022]

The dedicated pigtail catheter system successfully recanalized 55% of pulmonary embolic occlusions in an animal study involving ten dogs, demonstrating its efficacy in treating pulmonary embolism.

The catheter's embolus fragmentation technique significantly reduced the increase in pulmonary arterial pressure by 72%, indicating its potential to improve hemodynamic stability during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The diagnosis and fragmentation therapy of acute massive pulmonary embolism with a rotatable pigtail catheter: experimental studies]. Schmitz-Rode, T., Günther, RW., Neuerburg, J., et al.[2016]

Many patients with high-risk pulmonary embolism cannot receive thrombolytic therapy due to contraindications, highlighting the need for alternative treatments.

Catheter-based therapies, including newer techniques like pulmonary embolectomy, are gaining interest as potential options for these patients, although more data is needed to support their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Catheter-Based Embolectomy for Acute Pulmonary Embolism: Devices, Technical Considerations, Risks, and Benefits. Jaber, WA., McDaniel, MC.[2019]

The FlowTriever System is a mechanical thrombectomy device that effectively treats pulmonary embolism (PE) without the bleeding risks associated with thrombolytic drugs, making it a safer option for patients at intermediate and high risk.

Clinical data from multiple studies, including the FlowTriever Pulmonary Embolectomy Clinical Study, demonstrate the device's safety and effectiveness in resolving vascular occlusions and improving patient outcomes in PE cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FlowTriever System for Pulmonary Embolism: A Review of Clinical Evidence. Haner Wasserstein, D., Frishman, WH.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of Aspiration Catheters with Modified Standard Catheters for Treatment of Large Pulmonary Embolism Using an In-vitro Patho-Physiological Model. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy Evaluation of Aspiration Thrombectomy With Large Bore Catheters in a Porcine Model. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

AngioVac aspiration of right atrial cardiac pacemaker lead-associated thrombus with concurrent PE under fluoroscopic and transesophageal echocardiographic guidance: a multidisciplinary collaboration for improved patient outcome. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Contemporary Management of Acute Pulmonary Embolism: Evolution of Catheter-based Therapy. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

[The diagnosis and fragmentation therapy of acute massive pulmonary embolism with a rotatable pigtail catheter: experimental studies]. [2016]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Catheter-Based Embolectomy for Acute Pulmonary Embolism: Devices, Technical Considerations, Risks, and Benefits. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

FlowTriever System for Pulmonary Embolism: A Review of Clinical Evidence. [2023]