Indigo Aspiration System for Deep Vein Thrombosis

Recruiting at 39 trial locations

Overseen By Erin Archard

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Penumbra Inc.

Must not be taking: Anticoagulants, Thrombolytics

Disqualifiers: Prior DVT, Pulmonary embolism, Cancer, 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: 30

Duration: Index Procedure

290 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the Indigo Aspiration System to determine its safety and effectiveness in removing blood clots in people with deep vein thrombosis (DVT). DVT occurs when clots form in deep veins, often in the legs, causing pain and swelling. The trial targets individuals who have experienced symptoms for less than two weeks and whose clots affect specific veins in the leg. Participants should not have previous blood clots in the same leg or certain medical conditions that could interfere with the treatment. As an unphased trial, this study provides participants the chance to contribute to important research that could lead to new treatment options for DVT.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have a contraindication (reason not to use) to anticoagulants, which are blood-thinning medications.

What prior data suggests that the Indigo Aspiration System is safe for treating deep vein thrombosis?

Research shows that the Indigo Aspiration System is generally well-tolerated by patients. In studies with patients who had a pulmonary embolism (a blockage in the lung arteries), the system showed a low rate of serious side effects. This suggests it might also be safe for other conditions, like deep vein thrombosis (DVT), where a blood clot forms in a deep vein, usually in the leg.

Other studies have found it to be a safe and effective tool for removing blood clots in veins and arteries. Specifically, it has been successfully used for clots in the arms, supporting its reliability for treating DVT.

While these studies are encouraging, individual experiences can differ, so discussing any concerns with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Indigo Aspiration System is unique because it offers a minimally invasive approach to treating deep vein thrombosis (DVT). Unlike traditional treatments like anticoagulants, which can take a long time to dissolve clots and carry risk of bleeding, this system directly removes the clot using a catheter-based device. Researchers are excited because it has the potential to quickly restore blood flow, potentially reducing complications and improving patient outcomes more efficiently.

What evidence suggests that the Indigo Aspiration System is effective for deep vein thrombosis?

Research has shown that the Indigo Aspiration System effectively treats deep vein thrombosis (DVT), a condition where blood clots form in deep veins. Studies have found that this system can help clear blocked veins by removing blood clots. Early results suggest that this treatment might reduce the risk of postthrombotic syndrome (PTS), which can cause long-term leg pain and swelling. Used in real-world situations, the system has shown promising results in reducing vein blockages and improving blood flow. Overall, the Indigo Aspiration System has proven safe and effective for treating DVT. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a type of blood clot in the leg called Deep Vein Thrombosis (DVT) affecting certain veins. Participants must have had symptoms for less than two weeks and be able to give informed consent. People can't join if they have severe reactions to anticoagulants or contrast dye, life expectancy under one year, high-risk pulmonary embolism, bleeding disorders, are pregnant, or have other conditions that affect study participation.

Inclusion Criteria

Informed consent is obtained per Institutional Review Board requirements

I am receiving my first treatment with the Indigo Aspiration System for my vein condition.

I have a blood clot in my leg that extends to my lower abdomen.

Exclusion Criteria

I cannot take blood thinners due to health reasons.

I received clot-dissolving medication for a deep vein thrombosis within the last 14 days.

My cancer is spreading, getting worse, or I've had treatment in the 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 percutaneous mechanical thrombectomy using the Indigo Aspiration System

Index Procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Visits at baseline, 30 days, 180 days, 12 months, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Indigo Aspiration System

Trial Overview The BOLT study is testing the safety and effectiveness of the Indigo Aspiration System. This device is used in a procedure to remove clots from veins in patients with DVT. The goal is to see how well it works when it's the first treatment option chosen by doctors.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 1 Intervention

Use of Indigo Aspiration System in patients with obstruction due to DVT

Indigo Aspiration System is already approved in United States for the following indications:

Approved in United States as Indigo Aspiration System for:

• Removal of fresh, soft emboli and thrombi from vessels of the peripheral arterial and venous systems
• Treatment of pulmonary embolism

Who Is Running the Clinical Trial?

Penumbra Inc.

Lead Sponsor

Trials

38

Recruited

10,800+

Published Research Related to This Trial

A 30-year-old female with cerebral venous sinus thrombosis underwent successful endovascular thrombectomy using Penumbra's Indigo Aspiration System, which is typically used for peripheral thromboembolism, demonstrating its safety and efficacy in the cerebral venous system.

The combination of mechanical thrombectomy and anticoagulation treatment led to excellent functional outcomes and near-complete thrombus removal, highlighting the potential of this minimally invasive approach for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mechanical Venous Thrombectomy Using Indigo Aspiration System: A Case Report. Ota, RA., Neves, G., Montalvan, VC., et al.[2023]

The study introduces a new method for endovascular thrombectomy using the Penumbra Indigo® Aspiration System with balloon assistance, specifically targeting thromboembolic occlusions in the tibioperoneal trunk and tibial arteries.

This technique enhances the effectiveness of suction thrombectomy by utilizing a shorter, larger-diameter aspiration catheter, which addresses the limitations of traditional longer, smaller catheters, potentially improving outcomes for patients with acute limb ischemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balloon-Assisted Endovascular Thrombectomy for Tibial Thromboembolism. Roush, WP., Peters, A., Vogel, TR., et al.[2022]

The Penumbra Indigo® Aspiration System is an FDA-approved device that offers a new percutaneous option for treating pulmonary embolism, particularly in patients at intermediate risk, by achieving rapid recanalization of the pulmonary artery.

Recent studies show that using this device leads to better radiographic outcomes with low rates of major adverse events, suggesting it is a safe and effective alternative to traditional therapies for certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indigo® Aspiration System for thrombectomy in pulmonary embolism. Raza, HA., Horowitz, J., Yuriditsky, E.[2023]

Aspiration thrombectomy using the Indigo™ system offers a safer alternative to catheter-directed thrombolysis (CDT) for treating acute limb ischemia, as it avoids the risk of major complications like hemorrhagic stroke associated with lytic infusion.

The Indigo™ system effectively restores blood flow immediately without the need for lytic agents, making it a promising first-line treatment option for patients with acute limb ischemia, especially when thrombolysis is contraindicated or has failed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advantages to Indigo mechanical thrombectomy for ALI: device and technique. Yamada, R., Adams, J., Guimaraes, M., et al.[2016]

The Indigo System for vacuum-assisted catheter direct thrombus aspiration (IS-CDTA) achieved a technical success rate of 70% in treating acute lower limb ischemia (ALLI) in a study of 33 procedures involving 29 patients, with success increasing to 90% when followed by catheter-directed thrombolysis.

The study found that a shorter time from the onset of symptoms to the IS-CDTA procedure (median of 10 hours for good outcomes) significantly correlated with better treatment outcomes, highlighting the importance of timely intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Aspiration Thrombectomy with the Indigo System for Acute Lower Limb Ischemia: Preliminary experience and analysis of parameters affecting the outcome. Rossi, M., Tipaldi, MA., Tagliaferro, FB., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05003843

BOLT: Study of the Indigo® Aspiration System When Used ... The objective of this study is to demonstrate the safety and efficacy of the Indigo Aspiration system for percutaneous mechanical thrombectomy.

2. penumbrainc.com penumbrainc.com/clinical-evidence/

Clinical Evidence A Prospective, Multicenter Study of Patients with Deep Vein Thrombosis to Evaluate the Safety and Efficacy of the Indigo Aspiration System. Learn More. 1; 2 · 3 ...

3. evtoday.com evtoday.com/articles/2022-july/penumbras-indigo-system-with-lightning-intelligent-aspiration

Penumbra's Indigo™ System With Lightning™ Intelligent ... Early endovascular treatment of acute iliocavofemoral deep vein thrombosis (DVT) has been shown to reduce the incidence of postthrombotic syndrome (PTS) and ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2772930324013723

Outcomes From Mechanical Thrombectomy for Deep Vein ... We used a large, nationally representative, real-world database to compare outcomes in patients with DVT receiving MT with the AngioJet (AJ), ClotTriever (CT), ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9783165/

Catheter-Directed Interventions for the Treatment of Lower ... The ClotTreiver Outcomes (CLOUT) registry evaluated the effectiveness of the ClotTriever system in treating patients with DVT in the femoral veins, iliac veins, ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1936879820320124

Indigo Aspiration System for Treatment of Pulmonary ... The Indigo aspiration system was associated with a significant reduction in the RV/LV ratio and a low major adverse event rate in submassive PE patients.

7. evtoday.com evtoday.com/articles/2020-july/venous-and-arterial-thrombus-removal-with-the-indigo-system-pulmonary-embolism-indication

Venous and Arterial Thrombus Removal With the Indigo ... The Indigo System can be considered a safe and efficient instrument for the removal of acute venous thrombosis of the upper limb. In cases of heavy clot burden, ...

8. trial.medpath.com trial.medpath.com/clinical-trial/5b529094c7bcf98c/nct05003843-bolt-study-deep-vein-thrombosis-indigo-system

Study of the Indigo® Aspiration System When Used in Patients ... The objective of this study is to demonstrate the safety and efficacy of the Indigo Aspiration system for percutaneous mechanical thrombectomy in a ...