Combining procedures to improve blood flow during stroke treatment
Safety and Efficacy of Mechanical Thrombectomy Utilizing Reversal Flow
This study is testing a new way to improve blood flow during stroke treatment to see if combining different techniques can make the procedure safer and more effective for patients with blocked arteries in the brain.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MediSys Health Network Academic / other |
| Locations | 1 site (Jamaica, New York) |
| Trial ID | NCT06721338 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the safety and effectiveness of mechanical thrombectomy for stroke patients by integrating blood flow reversal techniques. The procedure involves accessing the common femoral artery to navigate to the brain and remove blockages causing ischemic strokes. By combining established methods, the study seeks to minimize complications and reduce the risk of subsequent strokes during treatment. The primary focus is on demonstrating the feasibility and safety of this innovative approach in patients with large vessel occlusions.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a large vessel occlusion and specific imaging criteria indicating a recent stroke.
Not a fit: Patients with posterior circulation occlusions or those with severe baseline functional impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce complications during stroke treatment and improve patient outcomes.
How similar studies have performed: While combining these specific procedures is novel, similar approaches in mechanical thrombectomy have shown promise in improving outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18-year-old * Last known well less than 24 hours * Large vessel occlusion of intra-cranial ICA or MCA M1 segment * ASPECTS of 4 or above * Baseline modified Rankin scale of 3 or less. * More than 20 ml penumbra on CTP * Less than 100 ml infarct core on CTP Exclusion Criteria: • Large vessel occlusion on the posterior circulation, with tandem occlusion, has known history of patent foramen ovale, has deep venous thrombosis of lower extremity, absent family members to consent, large established stroke on CT/CT Perfusion with ASPECTS \<5, the individual consenting is a non-English speaker, and poor baseline function will be excluded from the study
Where this trial is running
Jamaica, New York
- Jamaica Hospital Medical Center — Jamaica, New York, United States (Recruiting)
Study contacts
- Study coordinator: Mohsen Nouri, MD
- Email: mnouri@jhmc.org
- Phone: 646-880-7742
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.