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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and effectiveness of a new device, the Viper Catheter System, for treating submassive pulmonary embolism—a serious but not immediately life-threatening blood clot in the lungs. The trial aims to determine if the device can safely remove these clots. Individuals who have experienced sudden symptoms of a submassive pulmonary embolism for 14 days or less may qualify. As an unphased trial, it offers patients the chance to contribute to pioneering research that could lead to new treatment options.

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 prior data suggests that the Viper Catheter System is safe for pulmonary embolism treatment?

Research shows that the Viper Catheter System is designed to safely remove blood clots from the lungs. This system is being tested for its effectiveness in treating pulmonary embolism (PE), a condition where blood clots block blood flow in the lungs.

Although specific safety data for the Viper Catheter System is limited, the trial's focus on safety ensures close monitoring of any side effects. In its early stages, the trial aims to gather initial safety information, with researchers carefully observing for any unwanted side effects.

In similar treatments for PE using other catheter systems, researchers have observed improvements in heart function without major safety issues. This is promising, but it's important to remember that every new treatment can have different effects.

For those considering joining this trial, safety remains a top priority. The research team will provide detailed information about any potential risks and benefits before participation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Viper Catheter System is unique because it offers a new way to treat pulmonary embolism by directly targeting the blood clot in the lungs. Unlike traditional treatments that may rely on blood thinners or surgical procedures, this catheter system uses a minimally invasive approach to physically break up and remove the clot. Researchers are excited because this method could potentially provide faster relief and reduce the risk of complications associated with more invasive surgeries or prolonged medication use.

What evidence suggests that the Viper Catheter System is effective for pulmonary embolism?

Research has shown that the Viper Catheter System, which participants in this trial may receive, effectively treats acute submassive pulmonary embolism, or blood clots in the lung arteries. Early trial results indicated that the device successfully removed blood clots in all patients studied. This suggests the Viper Catheter System could be a promising tool for addressing this serious condition. While more information will provide further insights, these early findings are encouraging for those considering this treatment option. ^{1 2 3 6 7}

Who Is on the Research Team?

Andrew Klein, MD

Principal Investigator

Piedmont Heart

Julie Bulman, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Are You a Good Fit for This Trial?

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.

Prior PE within last 6 months

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. withpower.com withpower.com/trial/phase-4feb8

Viper Catheter System for Pulmonary Embolism 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11635272/

Research progress in interventional therapy for acute ... ... effectiveness of the Viper Catheter System (Hēlo). According to preliminary trial results, emboli were successfully removed using the device in all patients.

3. acc.org acc.org/Latest-in-Cardiology/Articles/2023/07/01/42/Peripheral-Matters-Pulmonary-Embolism-State-of-the-Union-and-Future-Directions

Peripheral Matters | Pulmonary Embolism: State of the ... This review aims to provide a summary of the current treatment paradigms for those with intermediate-high- and high-risk PE, and to discuss ongoing trials.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9676610/

Early-term outcomes of the pulmonary embolism response ... Pulmonary embolism response teams (PERT) might improve outcomes of pulmonary embolism with faster evaluation and increased usage of advanced treatment methods.

5. withpower.com withpower.com/clinical-trials/for-pulmonary-embolism

Top Pulmonary Embolism Clinical Trials | Power 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 ...

6. researchgate.net researchgate.net/publication/387106551_Research_progress_in_interventional_therapy_for_acute_intermediate-high-risk_and_high-risk_pulmonary_embolism

Research progress in interventional therapy for acute ... the effects of Bashir catheters for intermediate-risk PE. The data showed that the RV/LV ratio improved by. 33.3% within 48 h after surgery, ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/P130005b.pdf

fda summary of safety and effectiveness data (ssed) System (OAS) is a percutaneous, catheter-based orbital atherectomy system designed to ... Pulmonary embolism. 0 (0.0%). 0. 1 (0.2%). 1. 1 (0.2%).