Using a new method to treat acute limb ischemia
The Role of Pharmaco-mechanical Thrombectomy in Management of Acute Lower Extremity Arterial Ischemia
This study is testing a new way to treat people with severe leg blood flow problems to see if it can restore blood flow faster and with fewer complications than current methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assiut University Academic / other |
| Locations | 1 site (Asyūţ) |
| Trial ID | NCT06222658 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to improve the treatment of acute lower extremity arterial ischemia (ALLI) by employing a combination of balloon maceration and pharmacomechanical thrombectomy (PMT) using the AngioJet Thrombectomy System. The goal is to quickly restore blood flow while minimizing complications associated with traditional thrombolytic therapies and open surgery. The study will include patients experiencing acute or subacute limb ischemia due to thrombotic or embolic occlusions. By addressing the limitations of existing treatment options, this approach seeks to enhance patient outcomes and reduce the risk of limb amputation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have experienced symptoms of acute limb ischemia within the last 14 days.
Not a fit: Patients with irreversible limb ischemia, those with certain vascular conditions, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this method could significantly reduce the risk of limb amputation and improve recovery times for patients with acute limb ischemia.
How similar studies have performed: Previous studies have indicated that pharmacomechanical thrombectomy can provide rapid reperfusion and has a favorable risk profile, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Asyūţ
- Asyut University Hospital — Asyūţ, Egypt (Recruiting)
Study contacts
- Study coordinator: ahmed m rashed
- Email: ahmedrashed9933@gmail.com
- Phone: 00201064252719
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.