Indigo Aspiration System for Deep Vein Thrombosis

Recruiting at 37 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

Trial Summary

What is the purpose of this trial?

The objective of this study is to demonstrate the safety and efficacy of the Indigo Aspiration system for percutaneous mechanical thrombectomy in a population presenting with obstruction due to deep vein thrombosis (DVT) who are eligible for treatment.

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.

How is the Indigo Aspiration System treatment different from other treatments for deep vein thrombosis?

The Indigo Aspiration System is unique because it uses a vacuum pump to actively remove blood clots without the need for clot-dissolving drugs, reducing the risk of bleeding complications. This system provides immediate restoration of blood flow and is minimally invasive, making it a promising option when traditional clot-dissolving treatments are not suitable or have failed. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

References

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

Mechanical Venous Thrombectomy Using Indigo Aspiration System: A Case Report. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Indigo® Aspiration System for thrombectomy in pulmonary embolism. [2023]

3. Italy pubmed.ncbi.nlm.nih.gov

Advantages to Indigo mechanical thrombectomy for ALI: device and technique. [2016]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Balloon-Assisted Endovascular Thrombectomy for Tibial Thromboembolism. [2022]

5. Netherlands 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. [2022]