The Role of Pharmaco-mechanical Thrombectomy in Management of Acute Lower Extremity Arterial Ischemia

Acute Limb Ischemia Clinical Trial

Official title:

The Role of Pharmaco-mechanical Thrombectomy in Management of Acute Lower Extremity Arterial Ischemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06222658
• Other study ID #: PMT in acute limb ischemia
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2024
• Est. completion date: December 20, 2025

Study information

• Verified date: January 2024
• Source: Assiut University
• Contact: ahmed m rashed
• Phone: 00201064252719
• Email: ahmedrashed9933[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 .

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 20, 2025
• Est. primary completion date: September 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Limb Ischemia
• Ischemia

Intervention

Device:
• pharmaco-mechanichal thrombectomy
pharmaco-mechanichal thrombectomy in acute limb ischemia

Locations

Country	Name	City	State
Egypt	Asyut University Hospital	Asyut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

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. — View Citation

Leung 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	immediately after angiography
Primary	Amputation-free survival	freedom from amputation to the treated limb or mortality at follow-up at 30 days, 6 months and 1 year	1 year

External Links

•   Fast-track thrombolysis protocol for acute limb ischemia
•   Rheolytic Pharmacomechanical Thrombectomy for the Management of Acute Limb Ischemia: Results From the PEARL Registry