Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages Any age
• All sexes
• No healthy volunteers
• Child, Adult, Older adult

Study population: The INDIGO System is intended for use in patients with acute lower limb artery occlusion, acute superior mesenteric artery occlusion, or severe acute deep vein thrombosis who require immediate treatment and for whom it is difficult to perform surgical thrombectomy or who are expected to have no effective therapeutic effect.

Trial locations and contacts

1 site in 1 country.

About this study

Conditions

Acute Limb Ischemia, Arterial Occlusion Mesenteric Artery Superior, Acute DVT of Lower Extremity

Being tested

Mechanical aspiration thrombectomy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Mechanical aspiration thrombectomyDevice

  Mechanical thrombectomy is an endovascular technique for removing blood clots from vessels. Penumbra's Indigo system actively extracts thrombus using a continuous vacuum pump, enabling aspiration of thrombus of various sizes and lengths.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. ALI: Target Limb Salvage

   Target lower extremity salvage rate at (defined as: freedom from major amputation at or proximal to the ankle)

   Measured: 30 days post-treatment and 6 months post-treatment

2. ALI: Technical Success

   Primary technical success should be defined per vessel treated on an intent-to-treat basis and applies only to segment treated with Indigo. Defined as successful use of the device to re-establish any antegrade flow and complete or near complete (95% by volume) removal of thrombus as assessed by visual analysis of angiographic images or by other objective imaging such as DUS, CTA, or MRA.

   Measured: Intraoperative

3. ALI: Major device-related bleeding in ALI patients

   Major bleeding events as defined by ISTH

   Measured: Periprocedural

4. SMA: Technical success

   Restoration of antegrade blood flow without the need for other revascularization procedures such as vascular surgery or bypass.

   Measured: Intraoperative

5. SMA: Device-related Distal Embolization

   A distal filling defect with an abrupt cut-off, determined to be new since the pre-procedure angiogram, present at the end of the procedure, and clinically significant requiring intervention other than Indigo use. If the area in question was not clearly visualized, filling defects distal to the target lesion cannot be categorized as emboli.

   Measured: Intraoperative

6. DVT: Technical success

   Complete or near complete (75% or more) reduction in venous thrombosis, as assessed by visual evaluation of intraoperative venography

   Measured: Intraoperative

7. DVT: Major Device-Related Bleeding

   Major device-related bleeding as defined by ISTH

   Measured: Periprocedural

8. DVT: New Symptomatic Pulmonary Embolism (PE)

   Symptomatic new PE objectively confirmed on Computed Tomographic Pulmonary Angiography (CTPA), echocardiography, MRI, or invasive contrast pulmonary angiography.

   Measured: 30 days post-treatment

9. DVT: Clinically significant re-thrombosis of the target venous segment

   Re-thrombosis of target vein segment requiring re-intervention within 30 days

   Measured: 30 days post-treatment

10. All Disease States: Device-related Serious adverse effects (SAE) and mortality

    Device related SAE and all-cause mortality

    Measured: 6 months post-treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted6 Jun 2024
2. Study start7 Dec 2023
3. Primary completion25 Jul 2025
4. Study completion25 Jul 2025

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Acute Limb IschemiaStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.