An interventional study of pharmaco-mechanichal thrombectomy in Acute Limb Ischemia, sponsored by Assiut University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-25.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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 .
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 .
2,058 studies on the registry are indexed under Ischemia; 347 are open to participants now.
This study's planned enrollment of 50 is below the median of 80 across 1,359 interventional studies indexed under Ischemia.
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Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Rutherford category I, IIa or IIb
Exclusion Criteria:
Device: pharmaco-mechanichal thrombectomy
pharmaco-mechanichal thrombectomy in acute limb ischemia
Also known as: Angiojet thrombectomy catheter
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
Time frame: 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
Time frame: 1 year
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Assiut University