Lower Limb IschemiaNCT03295539
Acute Limb Ischaemia (ALI) Management With 'Indigo' Mechanical Aspiration System
A study testing 'Indigo' Mechanical thrombectomy system in people with Lower Limb Ischemia, run by Lancashire Care NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
International Multi-Centre registry recording comprehensive data on the use of 'Indigo' Mechanical thrombectomy system by Penumbra Inc for the removal of acute clot causing acute or critical limb ischaemia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lower Limb Ischemia
- 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
- 400 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2017to 1 Mar 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Acute lower limb Ischaemia with acute soft clot.
Who cannot join
- Calcified plaques/ chronic disease causing critical limb Ischaemia
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Interventional Radiology
Preston, Lancashire, PR2 7HR
BELLA HUASEN, MD, 00447871800565, doctorbella.h@gmail.com
About this study
Official title: MulticentRe pOst-market exPeriencE With the INdigo Thrombectomy System for the Treatment of Acute Lower Limb Ischaemia : (Re-Open Registry)
International Multi-Centre registry recording comprehensive data on the use of 'Indigo' Mechanical thrombectomy system by Penumbra Inc for the removal of acute clot causing acute or critical limb ischaemia.
Read the detailed description
A detailed registry has been designed and approved to be used world wide in vascular and trauma centres, already providing endovascular service for the management of critical limb ischaemia (CLI).
Recent campaigns have shown little is done to improve flow to the lower limbs (legs) of patients to avoid amputation rates. During this time many devises have been used and available on the market. The 'Indigo' system by Penumbra was originally designed from the acute stroke system "ACE". Similar principles were applied in designing the 'Indigo' system. This is currently being used in many centres to manage acute clot causing lower limb ischaemia, however no official registry or international clinical trial has been done to show its significance in managing this disease.
The investigator groups, have created this to come up with enough data to evaluate the Indigo system in the management of (ALI) and offer tips and tricks to other clinicians. The aim is for a single arm, multicenter, retrospective analysis of patients in whom (ALI) was performed with the Penumbra/Indigo System (study device), and gather greater data and information than the PRISM trial in 2013-2014 which obtained only 79 patients.
- Conditions
- Lower Limb Ischemia
- Being tested
- 'Indigo' Mechanical thrombectomy system
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 from the artery causing ischaemia, using the mechanical aspiration system by Penumbra Inc called "INDIGO"
| Study group | Role | What they receive |
|---|---|---|
| Acute or Chronic clot | Other | If chronic clot, 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 using the Indigo system.
Intraoperative technical success defined as the restoration of antegrade blood flow with complete or near complete (95% by volume) removal of the thrombus or embolus (70% threshold). This is assessed using imaging modalities (USS/Doppler/Fluroscopy) and clinical assessment of the affected limb.
See for this definition the enclosed citation. In conclusion, the primary outcome measure will be improvement in blood flow across a lesion assessed by the improvement in Thrombolysis in Myocardial Infarction (TIMI) score that was adapted to peripheral arteries. Concomitant balloon angioplasty or stent placement in addition to VAT was considered a complementary treatment. Additional thrombectomy treatments, such as thrombolysis and mechanical thrombectomy, were considered technical failures.Target lesions were grouped anatomically into above-the-knee(ATK) or below-the-knee(BTK) lesions.
Measured: Time to event anaylsis. Primary patency results are immediate after the case on the final angiogram images.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start1 Nov 2017 (estimated)
- Primary completion1 Oct 2018 (estimated)
- Study completion1 Mar 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 Lower 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lancashire Care NHS Foundation Trust
- Sponsor type
- Research network
- Collaborators
- St. Franziskus Hospital
- Responsible party
- Principal investigator, Bella Huasen, Lancashire Care NHS Foundation Trust
- Investigators
- Bella Huasen, MD, Study chair, Lancashire NHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295539
- Sponsor's protocol ID
- Indigo2017
- Status last verified
- Oct 2017
- First submitted
- 6 Sep 2017
- Last updated
- 20 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The registry and data in-put
Publications
Karnabatidis D, Spiliopoulos S, Tsetis D, Siablis D. Quality improvement guidelines for percutaneous catheter-directed intra-arterial thrombolysis and mechanical thrombectomy for acute lower-limb ischemia. Cardiovasc Intervent Radiol. 2011 Dec;34(6):1123-36. doi: 10.1007/s00270-011-0258-z. Epub 2011 Sep 1.
PubMed 21882081
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MulticentRe pOst-market exPeriencE With the INdigo Thrombectomy System for the Treatment of Acute Lower Limb Ischaemia : (Re-Open Registry)
- ClinicalTrials.gov ID
- NCT03295539
- Acronym / sponsor ID
- Indigo2017
- Conditions
- Lower Limb Ischemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Lancashire Care NHS Foundation TrustResearch network
- Collaborators
- St. Franziskus Hospital
- Study start
- 1 Nov 2017 (estimated)
- Primary completion
- 1 Oct 2018 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 28 Sep 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.
International Multi-Centre registry recording comprehensive data on the use of 'Indigo' Mechanical thrombectomy system by Penumbra Inc for the removal of acute clot causing acute or critical limb ischaemia.
Detailed description
A detailed registry has been designed and approved to be used world wide in vascular and trauma centres, already providing endovascular service for the management of critical limb ischaemia (CLI).
Recent campaigns have shown little is done to improve flow to the lower limbs (legs) of patients to avoid amputation rates. During this time many devises have been used and available on the market. The 'Indigo' system by Penumbra was originally designed from the acute stroke system "ACE". Similar principles were applied in designing the 'Indigo' system. This is currently being used in many centres to manage acute clot causing lower limb ischaemia, however no official registry or international clinical trial has been done to show its significance in managing this disease.
The investigator groups, have created this to come up with enough data to evaluate the Indigo system in the management of (ALI) and offer tips and tricks to other clinicians. The aim is for a single arm, multicenter, retrospective analysis of patients in whom (ALI) was performed with the Penumbra/Indigo System (study device), and gather greater data and information than the PRISM trial in 2013-2014 which obtained only 79 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute or Chronic clot | Other | Device: 'Indigo' Mechanical thrombectomy systemIf chronic clot, no intervention given via Indigo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Acute lower limb Ischaemia with acute soft clot.
Key exclusion criteria (1 listed)
- Calcified plaques/ chronic disease causing critical limb Ischaemia
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 from the artery causing ischaemia, using the mechanical aspiration system by Penumbra Inc called "INDIGO" | Device | Acute or Chronic clot |
Primary outcome
Technical success using the Indigo system.
Time frame: Time to event anaylsis. Primary patency results are immediate after the case on the final angiogram images.
Intraoperative technical success defined as the restoration of antegrade blood flow with complete or near complete (95% by volume) removal of the thrombus or embolus (70% threshold). This is assessed using imaging modalities (USS/Doppler/Fluroscopy) and clinical assessment of the affected limb. See for this definition the enclosed citation. In conclusion, the primary outcome measure will be improvement in blood flow across a lesion assessed by the improvement in Thrombolysis in Myocardial Infarction (TIMI) score that was adapted to peripheral arteries. Concomitant balloon angioplasty or stent placement in addition to VAT was considered a complementary treatment. Additional thrombectomy treatments, such as thrombolysis and mechanical thrombectomy, were considered technical failures.Target lesions were grouped anatomically into above-the-knee(ATK) or below-the-knee(BTK) lesions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Results publication: PubMed 21882081Karnabatidis D, Spiliopoulos S, Tsetis D, Siablis D. Quality improvement guidelines for percutaneous catheter-directed intra-arterial thrombolysis and mechanical thrombectomy for acute lower-limb ischemia. Cardiovasc Intervent Radiol. 2011 Dec;34(6):1123-36. doi: 10.1007/s00270-011-0258-z. Epub 2011 Sep 1.
- Individual participant dataSharing planned: Yes. The registry and data in-put
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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.
Bella Huasen, MD study chair
Lancashire NHS
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 Lower Limb Ischemia, run by Lancashire Care NHS Foundation Trust at 1 site in United Kingdom.
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: status not confirmed, as of the sponsor's last update on 20 Oct 2017. 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 United Kingdom. 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 Bella Huasen, MD (00447871800565, doctorbella.h@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Technical success using the Indigo system. (time frame: Time to event anaylsis. Primary patency results are immediate after the case on the final angiogram images.). 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 NCT03295539, 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 20 Oct 2017; AzTrials last refreshed its copy on 6 Nov 2026.