Acute Limb IschemiaNCT06222658
The Role of Pharmaco-mechanical Thrombectomy in Management of Acute Lower Extremity Arterial Ischemia
A study testing pharmaco-mechanichal thrombectomy in people with Acute Limb Ischemia, run by Assiut University at 1 site in Egypt.
Trial summary
The goal of our protocol is to re-establish patency in ALLI, by combining both balloon maceration of a thrombus and angiojet PMT thus decreasing complications associated with prolonged periods of thrombolytic exposure while avoid open surgical risk . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Limb Ischemia
- What is being tested?
- pharmaco-mechanichal thrombectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2024to 20 Dec 2025
- 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
- Age ≥ 18 years
- Symptom onset within 14 days for acute limb ischemia or within 30 days for subacute limb ischemia due to embolic or thrombotic occlusion of a native arteries, bypass graft, or arterial stent.
- Rutherford category I, IIa or IIb
Who cannot join
- ALLI secondary to dissections, vasculitis, and/or target vessel trauma
- Pregnancy or positive pregnancy test
- Rutherford category III Irreversible (neglected) limb ischemia
- patients allergic to contrast agent,
- serum creatine>300 mmol/L
Trial locations and contacts
1 site in 1 country.
About this study
The goal of our protocol is to re-establish patency in ALLI, by combining both balloon maceration of a thrombus and angiojet PMT thus decreasing complications associated with prolonged periods of thrombolytic exposure while avoid open surgical risk .
Read the detailed description
Acute lower extremity arterial ischemia (ALLI) is a common emergency in vascular surgery that has a high risk of limb amputation and mortality .It is caused by the blockage of an arterial flow to an extremity, which can be either thrombotic or embolic . Timely diagnosis and proper treatment for ALI are critical as to save limb viability .
Treatment options include surgical embolectomy, catheter-directed thrombolysis (CDT) , as well as pharmacochemical thrombectomy , Each of those approaches has its own disadvantages.
Fogarty manoeuvre embolectomy although flexible technique that can be used in a variety of situation, it is an open surgical procedure, carries the risk of complications such as bleeding and wound healing disorders. Additionally, it may impose a risk of arterial wall injury in the presence of underlying arterial lesions.
While CDT avoids common surgical complication its advantages include high risk of thrombo-lytic bleeding, residual thrombosis and long operation time and hospital stay.
As to address those limitations previous research has shown that using PMT as a first-line treatment for ALI provides rapid reperfusion to the extremity, reduces procedure time, and has an low risk profile .
The AngioJet Thrombectomy System (Boston Scientific Corporation, Marlborough, MA, USA) is a rheolytic PMT device that utilizes pressurized saline jets to generate a localized low-pressure zone (Bernoulli principle that results in fragmentation of the thrombus at the distal tip of the catheter.
The saline jets also provide the driving force through which the macerated thrombus particles are removed from the lesion site through the catheter. Several studies have demonstrated the effectiveness of the AngioJet system .
The goal of our protocol is to re-establish patency in ALLI, by combining both balloon maceration of a thrombus and angiojet PMT thus decreasing complications associated with prolonged periods of thrombolytic exposure while avoid open surgical risk .
- Conditions
- Acute Limb Ischemia
- Being tested
- pharmaco-mechanichal thrombectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmaco-mechanichal thrombectomyDevice
Also called Angiojet thrombectomy catheter
pharmaco-mechanichal thrombectomy in acute limb ischemia
| Study group | Role | What they receive |
|---|---|---|
| Patient assigned to pharmacomechanichal thrombectomy | Experimental | Not described Receives: Device: pharmaco-mechanichal thrombectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure success
completion of the endovascular procedure without the need for further intervention for revascularization and an absence of substantial or complete occlusion in any vessel at final angiography
Measured: immediately after angiography
Amputation-free survival
freedom from amputation to the treated limb or mortality at follow-up at 30 days, 6 months and 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start20 Jan 2024 (estimated)
- Primary completion20 Sep 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Limb IschemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Rashed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222658
- Sponsor's protocol ID
- PMT in acute limb ischemia
- Status last verified
- Jan 2024
- First submitted
- 26 Sep 2023
- Last updated
- 25 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ascher E, Kibrik P, Rizvi SA, Alsheekh A, Marks N, Hingorani A. Fast-track thrombolysis protocol for acute limb ischemia. J Vasc Surg. 2021 Mar;73(3):950-959. doi: 10.1016/j.jvs.2020.03.061. Epub 2020 May 11.
PubMed 32437952Leung DA, Blitz LR, Nelson T, Amin A, Soukas PA, Nanjundappa A, Garcia MJ, Lookstein R, Simoni EJ. Rheolytic Pharmacomechanical Thrombectomy for the Management of Acute Limb Ischemia: Results From the PEARL Registry. J Endovasc Ther. 2015 Aug;22(4):546-57. doi: 10.1177/1526602815592849. Epub 2015 Jun 24.
PubMed 26109628
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Pharmaco-mechanical Thrombectomy in Management of Acute Lower Extremity Arterial Ischemia
- ClinicalTrials.gov ID
- NCT06222658
- Acronym / sponsor ID
- PMT in acute limb ischemia
- Conditions
- Acute Limb Ischemia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 20 Jan 2024 (estimated)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 25 Jan 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.
The goal of our protocol is to re-establish patency in ALLI, by combining both balloon maceration of a thrombus and angiojet PMT thus decreasing complications associated with prolonged periods of thrombolytic exposure while avoid open surgical risk .
Detailed description
Acute lower extremity arterial ischemia (ALLI) is a common emergency in vascular surgery that has a high risk of limb amputation and mortality .It is caused by the blockage of an arterial flow to an extremity, which can be either thrombotic or embolic . Timely diagnosis and proper treatment for ALI are critical as to save limb viability .
Treatment options include surgical embolectomy, catheter-directed thrombolysis (CDT) , as well as pharmacochemical thrombectomy , Each of those approaches has its own disadvantages.
Fogarty manoeuvre embolectomy although flexible technique that can be used in a variety of situation, it is an open surgical procedure, carries the risk of complications such as bleeding and wound healing disorders. Additionally, it may impose a risk of arterial wall injury in the presence of underlying arterial lesions.
While CDT avoids common surgical complication its advantages include high risk of thrombo-lytic bleeding, residual thrombosis and long operation time and hospital stay.
As to address those limitations previous research has shown that using PMT as a first-line treatment for ALI provides rapid reperfusion to the extremity, reduces procedure time, and has an low risk profile .
The AngioJet Thrombectomy System (Boston Scientific Corporation, Marlborough, MA, USA) is a rheolytic PMT device that utilizes pressurized saline jets to generate a localized low-pressure zone (Bernoulli principle that results in fragmentation of the thrombus at the distal tip of the catheter.
The saline jets also provide the driving force through which the macerated thrombus particles are removed from the lesion site through the catheter. Several studies have demonstrated the effectiveness of the AngioJet system .
The goal of our protocol is to re-establish patency in ALLI, by combining both balloon maceration of a thrombus and angiojet PMT thus decreasing complications associated with prolonged periods of thrombolytic exposure while avoid open surgical risk .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient assigned to pharmacomechanichal thrombectomy | Experimental | Device: pharmaco-mechanichal thrombectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Symptom onset within 14 days for acute limb ischemia or within 30 days for subacute limb ischemia due to embolic or thrombotic occlusion of a native arteries, bypass graft, or arterial stent.
- Rutherford category I, IIa or IIb
Key exclusion criteria (5 listed)
- ALLI secondary to dissections, vasculitis, and/or target vessel trauma
- Pregnancy or positive pregnancy test
- Rutherford category III Irreversible (neglected) limb ischemia
- patients allergic to contrast agent,
- serum creatine>300 mmol/L
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 |
|---|---|---|
| pharmaco-mechanichal thrombectomyAlso: Angiojet thrombectomy catheterpharmaco-mechanichal thrombectomy in acute limb ischemia | Device | Patient assigned to pharmacomechanichal thrombectomy |
Primary outcome
Procedure success
Time frame: immediately after angiography
completion of the endovascular procedure without the need for further intervention for revascularization and an absence of substantial or complete occlusion in any vessel at final angiography
Amputation-free survival
Time frame: 1 year
freedom from amputation to the treated limb or mortality at follow-up at 30 days, 6 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2024.
- Background: PubMed 32437952Ascher E, Kibrik P, Rizvi SA, Alsheekh A, Marks N, Hingorani A. Fast-track thrombolysis protocol for acute limb ischemia. J Vasc Surg. 2021 Mar;73(3):950-959. doi: 10.1016/j.jvs.2020.03.061. Epub 2020 May 11.
- Background: PubMed 26109628Leung DA, Blitz LR, Nelson T, Amin A, Soukas PA, Nanjundappa A, Garcia MJ, Lookstein R, Simoni EJ. Rheolytic Pharmacomechanical Thrombectomy for the Management of Acute Limb Ischemia: Results From the PEARL Registry. J Endovasc Ther. 2015 Aug;22(4):546-57. doi: 10.1177/1526602815592849. Epub 2015 Jun 24.
- Rheolytic Pharmacomechanical Thrombectomy for the Management of Acute Limb Ischemia: Results From the PEARL RegistryLink provided by the sponsor.
- Fast-track thrombolysis protocol for acute limb ischemiaLink provided by the sponsor.
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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 pharmaco-mechanichal thrombectomy in people with Acute Limb Ischemia, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 5 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 25 Jan 2024. 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 Egypt. 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 ahmed m rashed (00201064252719, ahmedrashed9933@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure success (time frame: immediately after angiography). The study lists 2 primary outcomes in all. 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 NCT06222658, which also lists 2 linked publications.
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 25 Jan 2024.