NCT06297863RecruitingPhase 2
Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke
Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke: a Multicenter, Randomised, Proof of Concept, Phase 2a/b Trial in Patients Treated With Mechanical Thrombectomy
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
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°).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 118 (estimated)
- First submitted
- 26 Feb 2024
- Start date
- 1 Mar 2025
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- University of Milano Bicocca
- Diseases
- Stroke
- NCT number
- NCT06297863
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 118
- From 1 Mar 2025 to the primary completion date, 30 Sept 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
Other illness
- Vomiting upon stroke onset.
- History of glaucoma.
- History or imaging findings of intracranial hypertension of any aetiology
Other
- Impaired consciousness, defined as NIHSS score of 2 or 3 of the item 1a (level of consciousness): not alert, requires repeated stimulation or unresponsive.
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale Civile SS. Nicola e Filippo Avezzano Pronto Soccorso Coordinator of this site? Confirm its status | Avezzano | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Not yet recruiting |
| Azienda Ospedaliera Policlinico Universitario "G. Martino" Coordinator of this site? Confirm its status | Messina | Italy | Not yet recruiting |
| Fondazione IRCCS San Gerardo dei Tintori - Monza Coordinator of this site? Confirm its status | Monza | Italy | Recruiting |
| Azienda Ospedaliero Universitaria Policlinico Umberto I Coordinator of this site? Confirm its status | Roma | Italy | Not yet recruiting |
| Ospedale Santa Maria della Misericordia Coordinator of this site? Confirm its status | Udine | Italy | Not yet recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.