Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT06222658
Status:
RECRUITING
Last Update Posted:
2024-01-25
First Post:
2023-09-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of Pharmaco-mechanical Thrombectomy in Management of Acute Lower Extremity Arterial Ischemia
Sponsor:
Assiut University
Organization:
Study Overview
Official Title:
The Role of Pharmaco-mechanical Thrombectomy in Management of Acute Lower Extremity Arterial Ischemia
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 .
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 .
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: