Acute Limb IschemiaJapanIndigoPMSNCT06446024
Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan
An observational study of Acute Limb Ischemia and Arterial Occlusion Mesenteric Artery Superior, run by Penumbra Inc. at 1 site in Japan.
Trial summary
This study aims to confirm the safety and effectiveness of the INDIGO Aspiration System in patients requiring immediate treatment for acute lower extremity artery occlusion, acute superior mesenteric artery occlusion, or severe acute deep vein thrombosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Limb Ischemia, Arterial Occlusion Mesenteric Artery Superior, Acute DVT of Lower Extremity
- What is being tested?
- Mechanical aspiration thrombectomy
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteJapan
- Study dates
- 7 Dec 2023to 25 Jul 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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.
Who may be able to join
- Patients who meet Appropriate Use Criteria per local Japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis.
Who cannot join
- Patients who do not meet Appropriate Use Criteria per local Japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to confirm the safety and effectiveness of the INDIGO Aspiration System in patients requiring immediate treatment for acute lower extremity artery occlusion, acute superior mesenteric artery occlusion, or severe acute deep vein thrombosis. Primary objective of the study is to collect predetermined data on use, safety and effectiveness, including clinical and technical performance of the INDIGO System in Japan.
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Indigo Aspiration System treatment | Mechanical aspiration thrombectomy Receives: Device: Mechanical aspiration thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
ALI: Major device-related bleeding in ALI patients
Major bleeding events as defined by ISTH
Measured: Periprocedural
SMA: Technical success
Restoration of antegrade blood flow without the need for other revascularization procedures such as vascular surgery or bypass.
Measured: Intraoperative
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
DVT: Technical success
Complete or near complete (75% or more) reduction in venous thrombosis, as assessed by visual evaluation of intraoperative venography
Measured: Intraoperative
DVT: Major Device-Related Bleeding
Major device-related bleeding as defined by ISTH
Measured: Periprocedural
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
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
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.
- First posted6 Jun 2024
- Study start7 Dec 2023
- Primary completion25 Jul 2025
- 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.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446024
- Sponsor's protocol ID
- 27548
- Acronym
- JapanIndigoPMS
- Status last verified
- Feb 2026
- First submitted
- 13 May 2024
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Market Surveillance to Evaluate the Efficacy and Safety of the INDIGO Aspiration System in Japan
- ClinicalTrials.gov ID
- NCT06446024
- Acronym / sponsor ID
- JapanIndigoPMS / 27548
- Conditions
- Acute Limb Ischemia, Arterial Occlusion Mesenteric Artery Superior, Acute DVT of Lower Extremity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 6 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to confirm the safety and effectiveness of the INDIGO Aspiration System in patients requiring immediate treatment for acute lower extremity artery occlusion, acute superior mesenteric artery occlusion, or severe acute deep vein thrombosis. Primary objective of the study is to collect predetermined data on use, safety and effectiveness, including clinical and technical performance of the INDIGO System in Japan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1: Indigo Aspiration System treatment | – | Device: Mechanical aspiration thrombectomyMechanical aspiration thrombectomy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Patients who meet Appropriate Use Criteria per local Japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis.
Key exclusion criteria (1 listed)
- Patients who do not meet Appropriate Use Criteria per local Japanese requirements for acute lower limb artery, acute upper mesentery artery occlusions, or severe acute deep vein thrombosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical aspiration thrombectomyMechanical 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. | Device | Group 1: Indigo Aspiration System treatment |
Primary outcome
ALI: Target Limb Salvage
Time frame: 30 days post-treatment and 6 months post-treatment
Target lower extremity salvage rate at (defined as: freedom from major amputation at or proximal to the ankle)
ALI: Technical Success
Time frame: Intraoperative
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.
ALI: Major device-related bleeding in ALI patients
Time frame: Periprocedural
Major bleeding events as defined by ISTH
SMA: Technical success
Time frame: Intraoperative
Restoration of antegrade blood flow without the need for other revascularization procedures such as vascular surgery or bypass.
SMA: Device-related Distal Embolization
Time frame: Intraoperative
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.
DVT: Technical success
Time frame: Intraoperative
Complete or near complete (75% or more) reduction in venous thrombosis, as assessed by visual evaluation of intraoperative venography
DVT: Major Device-Related Bleeding
Time frame: Periprocedural
Major device-related bleeding as defined by ISTH
DVT: New Symptomatic Pulmonary Embolism (PE)
Time frame: 30 days post-treatment
Symptomatic new PE objectively confirmed on Computed Tomographic Pulmonary Angiography (CTPA), echocardiography, MRI, or invasive contrast pulmonary angiography.
DVT: Clinically significant re-thrombosis of the target venous segment
Time frame: 30 days post-treatment
Re-thrombosis of target vein segment requiring re-intervention within 30 days
All Disease States: Device-related Serious adverse effects (SAE) and mortality
Time frame: 6 months post-treatment
Device related SAE and all-cause mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Limb Ischemia and Arterial Occlusion Mesenteric Artery Superior, run by Penumbra Inc. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALI: Target Limb Salvage (time frame: 30 days post-treatment and 6 months post-treatment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.