The Role of Pharmaco-mechanical Thrombectomy in Management of Acute Lower Extremity Arterial Ischemia
1 other identifier
interventional
50
1 country
1
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2023
CompletedStudy Start
First participant enrolled
January 20, 2024
CompletedFirst Posted
Study publicly available on registry
January 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2025
CompletedJanuary 25, 2024
January 1, 2024
1.7 years
September 26, 2023
January 15, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (1)
Patient assigned to pharmacomechanichal thrombectomy
EXPERIMENTALInterventions
pharmaco-mechanichal thrombectomy in acute limb ischemia
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asyut University Hospital
Asyut, Egypt
Related 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.
PMID: 32437952BACKGROUNDLeung 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.
PMID: 26109628BACKGROUND
Related Links
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- dr
Study Record Dates
First Submitted
September 26, 2023
First Posted
January 25, 2024
Study Start
January 20, 2024
Primary Completion
September 20, 2025
Study Completion
December 20, 2025
Last Updated
January 25, 2024
Record last verified: 2024-01