Aspiration Thrombectomy for Cancer

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Overseen ByVarshana Gurusamy, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how aspiration thrombectomy can improve the quality of life for cancer patients with intermediate-risk pulmonary embolism (PE), a blockage in the lung's blood vessels. It also evaluates the safety of this procedure for these patients. The trial uses a specific tool, the Penumbra Element Sheath, to perform the thrombectomy. Cancer patients with a confirmed PE through a specific scan might be suitable candidates for this trial. As an unphased trial, it offers patients the chance to contribute to important research that could enhance future treatment options for others.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it allows for standard concurrent chemotherapy, immunotherapy, or targeted therapy, so you may be able to continue those treatments.

What prior data suggests that aspiration thrombectomy is safe for cancer patients with intermediate risk PE?

Research has shown that using the Penumbra Element Sheath for aspiration thrombectomy is generally safe and well-tolerated. One study found that patients treated with this method had shorter hospital stays, indicating a smoother recovery. Another set of data showed that this approach not only improves health outcomes but also reduces overall healthcare needs, suggesting the treatment is both effective and manageable for patients.

Regarding safety, previous trials have reported low rates of serious complications. For example, one study on deep vein thrombosis reported no deaths in certain patient groups, indicating a relatively low risk of severe side effects.

Overall, the evidence supports the safety of aspiration thrombectomy for treating blood clots, making it a promising option for those considering joining a clinical trial.12345

Why are researchers excited about this trial?

Aspiration thrombectomy is unique because it offers a new way to remove blood clots in cancer patients by using a mechanical suction device called the Penumbra Element Sheath. Unlike traditional treatments that may rely on medications or invasive surgery to dissolve or remove clots, this method directly extracts the clot, potentially reducing the risk of bleeding and other complications. Researchers are excited about this treatment because it could provide a quicker, more targeted approach to managing clots, leading to faster recovery and improved outcomes for patients with cancer-related thrombosis.

What evidence suggests that aspiration thrombectomy is effective for cancer patients with intermediate risk PE?

Research shows that the Penumbra Element Sheath effectively removes blood clots. In this trial, participants will receive treatment with the Penumbra Element Sheath. Studies have found that this procedure aids recovery and improves health outcomes. It is considered safe and efficiently speeds up recovery. Evidence from various studies, including STRIKE-PE and STRIDE, supports its potential as a treatment for blood clots. Overall, this method offers promising results, especially in improving the quality of life for patients with conditions like intermediate-risk pulmonary embolism (PE).26789

Who Is on the Research Team?

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Varshana Gurusamy, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for cancer patients who have a condition called intermediate risk pulmonary embolism (PE). Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and not have conditions that could interfere with the study or their safety.

Inclusion Criteria

I have been diagnosed with cancer before.
Confirmed PE based on computed tomographic pulmonary angiography (CTPA) imaging showing a filling defect in at least one main or proximal lobar pulmonary artery
Classification of intermediate risk PE as defined by the institutional PERT algorithm
See 8 more

Exclusion Criteria

Allergy, hypersensitivity, or heparin-induced thrombocytopenia (HIT)
Pregnancy
Patients on ECMO
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo computer-assisted vacuum thrombectomy (CAVT) for intermediate risk pulmonary embolism

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments at 48 hours and 90 days post-procedure

12 weeks
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Aspiration Thrombectomy

Trial Overview

The study is examining the use of Computer-assisted Vacuum Thrombectomy (CAVT) in treating PE among cancer patients. It aims to assess both the safety of this procedure and its impact on patients' quality of life after treatment.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Treatment with Penumbra Element SheathExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

Citations

Seven New Data Sets Demonstrate Penumbra's Computer ...

The data showed that CAVT as a frontline therapy for blood clots not only improved clinical and functional outcomes but can also help reduce overall healthcare ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/PMC10546392

Aspiration thrombectomy with the Penumbra System for ...

Background: The purpose of this study was to report the safety and performance of aspiration thrombectomy with the Penumbra System for patients ...

3.

penumbrainc.com

penumbrainc.com/sir-2025/

Latest Data on Penumbra's CAVT Technology to Be ...

New data from the ongoing STRIKE-PE and STRIDE studies will be presented at the Society of Interventional Radiology (SIR) Annual Scientific Meeting.

Computer-Aided Thrombus Removal Using Penumbra's ...

The Lightning Intelligent Aspiration System (Penumbra, Inc.) shows potential to be a successful treatment option for thrombotic disease.

Outcomes From Mechanical Thrombectomy for Deep Vein ...

These results suggest that all MT interventions may be unequal in terms of outcomes and resources, with the CT device associated with lower in-hospital ...

Latest Data Show Patients Managed with Penumbra's ...

The research shows that patients who are managed with Penumbra's CAVT experience shorter hospital stays and are more likely to be discharged to ...

A prospective, multicenter, randomized controlled trial ...

The STORM-PE trial will help inform future guidelines and standards of care related to frontline treatment using mechanical thrombectomy with CAVT.

Venous Health and Economic Optimization With CAVT

A 17-F, 65-cm Element sheath was placed, intended to facilitate the delivery of the 16-F aspiration catheter with the Select +™ dilator (Penumbra, Inc.) ...

Outcomes From Mechanical Thrombectomy for Deep Vein ...

The all-cause in-hospital mortality rate for patients with isolated IVC thrombus was 10% (n = 2/20), 0% (n = 0/18), and 0% (n = 0/23) for the AJ ...