Acute Ischemia of Lower LimbINDIANNCT03386370
The Indigo System in Acute Lower Limb Malperfusion
A study testing "Indigo" Mechanical Thrombectomy System in people with Acute Ischemia of Lower Limb, run by Azienda Ospedaliera Universitaria Senese at 1 site in Italy.
Trial summary
To evaluate, in a controlled setting, the early safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (San Francisco, California), and to define optimal technique for the use of these systems in patients with confirmed peripheral acute occlusions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemia of Lower Limb
- What is being tested?
- "Indigo" Mechanical Thrombectomy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2017to May 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient presenting with an acute occlusion of lower limb arteries (thrombosis no longer than 14 days)
- Patient presenting a score from I to IIb following Rutherford classification for acute limb ischemia
- Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study
- Patient is >18 years old
- Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
- Patient is eligible for treatment with the Indigo System (Penumbra)
Who cannot join
- Estimated time of intraluminal thrombus > 14 days
- Patients refusing treatment
- Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
- Patients with a history of prior life-threatening contrast medium reaction
- Life expectancy of less than six months
- Any patient considered to be hemodynamically unstable at onset of procedure
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Vascular Surgery, University of Siena
Siena, 53100
Gianmarco de Donato, MD
Carlo Setacci, MD
About this study
Official title: Indian Registry (The INDigo System in Acute Lower Limb malperfusioN)
To evaluate, in a controlled setting, the early safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (San Francisco, California), and to define optimal technique for the use of these systems in patients with confirmed peripheral acute occlusions.
- Conditions
- Acute Ischemia of Lower Limb
- Being tested
- "Indigo" Mechanical Thrombectomy System
- Keywords
- Acute ischemia, Lower Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Indigo" Mechanical Thrombectomy SystemDevice
Removal of acute clot (< 14 days) from the artery causing lower limb ischemia, using the "Indigo" System by Penumbra
| Study group | Role | What they receive |
|---|---|---|
| Treatment by "Indigo" mechanical thrombectomy system | Other | Acute or Chronic clot: if chronic (> 14 days) no intervention given via Indigo Receives: Device: "Indigo" Mechanical Thrombectomy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical success of the thromboaspiration with the Indigo system.
The primary endpoint of the study is the technical success of the thromboaspiration with the Indigo system. Assessment of vessel patency will be recorded using the Thrombolysis in Myocardial Infarction (TIMI) score classifications both before and after use of the device.
Measured: At intra-procedural completion angiography
Secondary outcomes (3)
Clinical success at 1 month follow-up.
Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
Measured: 1 month
Safety Rate at discharge: Serious adverse event.
Safety rate at discharge, defined as absence of any serious adverse events (SAE). A SAE is defined as any clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability.
Measured: 1 month
Primary Patency
Primary patency at 1 month. Primary patency is defined as a target lesion without a hemodynamically significant stenosis/reocclusion on duplex ultrasound (>50%,) and without target lesion reintervention (TLR) within 1 month.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2017
- Study start1 Sep 2017
- Primary completionMar 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemia of Lower LimbStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Senese
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Setacci, Gianmarco de Donato, Azienda Ospedaliera Universitaria Senese
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03386370
- Sponsor's protocol ID
- Indian001
- Acronym
- INDIAN
- Status last verified
- Jan 2019
- First submitted
- 18 Dec 2017
- Last updated
- 10 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Yamada R, Adams J, Guimaraes M, Schonholz C. Advantages to Indigo mechanical thrombectomy for ALI: device and technique. J Cardiovasc Surg (Torino). 2015 Jun;56(3):393-400. Epub 2015 Feb 3.
PubMed 25644826
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indian Registry (The INDigo System in Acute Lower Limb malperfusioN)
- ClinicalTrials.gov ID
- NCT03386370
- Acronym / sponsor ID
- INDIAN / Indian001
- Conditions
- Acute Ischemia of Lower Limb
- Keywords
- Acute ischemia, Lower Limb
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria SeneseUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 29 Dec 2017 (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.
To evaluate, in a controlled setting, the early safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (San Francisco, California), and to define optimal technique for the use of these systems in patients with confirmed peripheral acute occlusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment by "Indigo" mechanical thrombectomy system | Other | Device: "Indigo" Mechanical Thrombectomy SystemAcute or Chronic clot: if chronic (> 14 days) no intervention given via Indigo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient presenting with an acute occlusion of lower limb arteries (thrombosis no longer than 14 days)
- Patient presenting a score from I to IIb following Rutherford classification for acute limb ischemia
- Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study
- Patient is >18 years old
- Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
Key exclusion criteria (6 listed)
- Estimated time of intraluminal thrombus > 14 days
- Patients refusing treatment
- Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
- Patients with a history of prior life-threatening contrast medium reaction
- Life expectancy of less than six months
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 |
|---|---|---|
| "Indigo" Mechanical Thrombectomy SystemRemoval of acute clot (< 14 days) from the artery causing lower limb ischemia, using the "Indigo" System by Penumbra | Device | Treatment by "Indigo" mechanical thrombectomy system |
Primary outcome
Technical success of the thromboaspiration with the Indigo system.
Time frame: At intra-procedural completion angiography
The primary endpoint of the study is the technical success of the thromboaspiration with the Indigo system. Assessment of vessel patency will be recorded using the Thrombolysis in Myocardial Infarction (TIMI) score classifications both before and after use of the device.
3 secondary outcomes
Clinical success at 1 month follow-up.
Time frame: 1 month
Safety Rate at discharge: Serious adverse event.
Time frame: 1 month
Primary Patency
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2019.
- Background: PubMed 25644826Yamada R, Adams J, Guimaraes M, Schonholz C. Advantages to Indigo mechanical thrombectomy for ALI: device and technique. J Cardiovasc Surg (Torino). 2015 Jun;56(3):393-400. Epub 2015 Feb 3.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Indigo" Mechanical Thrombectomy System in people with Acute Ischemia of Lower Limb, run by Azienda Ospedaliera Universitaria Senese at 1 site in Italy.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 10 Jan 2019. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gianmarco de Donato, MD (+390577585123, dedonato@unisi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success of the thromboaspiration with the Indigo system. (time frame: At intra-procedural completion angiography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03386370, which also lists 1 linked publication.
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 10 Jan 2019.