NCT06297863 Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke
| NCT ID | NCT06297863 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Milano Bicocca |
| Condition | Acute Ischemic Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 118 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 118 participants in total. It began in 2025-03-01 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The DOWN-SUITE study is multicenter, randomised, controlled, open-label clinical trial with blinded outcome assessment comparing collateral status in patients with acute ischemic stroke treated with an in-hospital application of head down tilt -10° to -15° (HDT15) versus usual positioning (0° to +30°) before endovascular mechanical thrombectomy. This study will involve adult patients who are eligible for mechanical thrombectomy and who have acute ischemic stroke due to left or right middle cerebral artery occlusion (M1 segment). The investigators hypothesise that HDT15, applied in acute ischemic stroke patients with a large vessel occlusion, will improve collateral circulation, prolong the survival of the ischemic penumbra and improve the clinical benefit from mechanical thrombectomy compared with standard of care (usual positioning 0° to +30°).
Eligibility Criteria
Inclusion Criteria: * Acute ischemic stroke due to left or right MCA occlusion of the M1 segment (excluding occlusion of the internal carotid artery terminus + M1) * Decision to treat with mechanical thrombectomy (with or without intravenous thrombolysis) * Informed consent obtained from patient or patient's next of kin, or emergency consent procedure Exclusion Criteria: * Impaired consciousness, defined as NIHSS score of 2 or 3 of the item 1a (level of consciousness): not alert, requires repeated stimulation or unresponsive. * Vomiting upon stroke onset. * History of glaucoma. * History or imaging findings of intracranial hypertension of any aetiology * Major breath disorders, defined as follows: * oxygen saturation ≤92% in room air at admission * severe chronic obstructive pulmonary disease (COPD) treated with long-term oxygen therapy. * severe heart failure with NYHA class 3 or 4 (breathlessness during ordinary physical activity or at rest). * Severe obesity, defined as body mass index (BMI) \> 35. * Patients participating in another interventional trial that would interfere with this study. * Female patients who are pregnant
Contact & Investigator
Simone Beretta, MD, PhD
PRINCIPAL INVESTIGATOR
University of Milano Bicocca
Frequently Asked Questions
Who can join the NCT06297863 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06297863 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06297863 currently recruiting?
Yes, NCT06297863 is actively recruiting participants. Contact the research team at simone.beretta@unimib.it for enrollment information.
Where is the NCT06297863 trial being conducted?
This trial is being conducted at Avezzano, Italy, Florence, Italy, Messina, Italy, Monza, Italy and 2 additional locations.
Who is sponsoring the NCT06297863 clinical trial?
NCT06297863 is sponsored by University of Milano Bicocca. The principal investigator is Simone Beretta, MD, PhD at University of Milano Bicocca. The trial plans to enroll 118 participants.
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