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Taking people in ItalyPhase 2

Head-Down Tilt Positioning Tested in Acute Stroke Patients Before Thrombectomy

Tests head-down tilt positioning in adults with acute ischemic stroke before thrombectomy.

Key facts

Who runs it
University of Milano Bicocca
Where
Avezzano, Florence, Messina, Monza, Roma, and Udine, ItalySee the 6 sites
Trial code
Registry title
Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke
Status
Recruiting
Phase
Phase 2
People taking part
118 people, planned
Started
1 Mar 2025
Expected to end
31 Dec 2026
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • HEAD DOWN TILT -10° to -15°
Record updated
6 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a sudden stroke caused by a blocked brain artery (M1 segment of the middle cerebral artery), who will have a thrombectomy.

Age
18 years or older
Sex
All sexes can join
Disease stage
Acute ischemic stroke from a blockage of the left or right middle cerebral artery (M1 segment), not including a blockage at the end of the internal carotid artery plus M1
Earlier treatment
The decision has been made to treat with mechanical thrombectomy, with or without a clot-dissolving drug given into a vein

Main reasons for not taking part

  • Reduced alertness at stroke onset (NIHSS item 1a score of 2 or 3)
  • Vomiting when the stroke began
  • History of glaucoma
  • Raised pressure inside the skull, now or in the past
  • Serious breathing, lung or heart problems, or body mass index (BMI) above 35, or being pregnant

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)
  • Vomiting upon stroke onset
  • History of glaucoma
  • History or imaging findings of intracranial hypertension of any aetiology
  • 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

Where in Italy

  • Ospedale Civile SS. Nicola e Filippo Avezzano Pronto SoccorsoAvezzano, ItalyContact: Simona Sacco, MD, PhD (principal investigator)Not yet recruiting
  • Azienda Ospedaliero-Universitaria CareggiFlorence, ItalyContact: Enrico Fainardi, MD, PhD (principal investigator)Not yet recruiting
  • Azienda Ospedaliera Policlinico Universitario "G. Martino"Messina, ItalyContact: Sergio Vinci, MD, PhD (principal investigator)Not yet recruiting
  • Fondazione IRCCS San Gerardo dei Tintori - MonzaMonza, ItalyContact: Simone Beretta, MD, PhD (principal investigator)Taking people
  • Azienda Ospedaliero Universitaria Policlinico Umberto IRoma, ItalyContact: Danilo Toni, MD, PhD (principal investigator)Not yet recruiting
  • Ospedale Santa Maria della MisericordiaUdine, ItalyContact: Francesco Janes, MD, PhD (principal investigator)Not yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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°).

The 2 groups in the trial

  • HEAD DOWN TILT -10° to -15° (HDT15)Treatment being tested

    HDT15 will be applied in the intervention group in 2 different settings: * in the Emergency Room, by tilting the stretcher to lower the head by -10° to -15° relative to the body of the patient; the degree of tilting will be checked using a dedicated digital inclinometer or a mobile phone app * in the Angiography Suite, by tilting the angiography table to lower the head by -10° to -15° relative to the body of the patient, depending on the actual technology of the angiography system of each clinical site; the degree of tilting will be automatically checked using the angiography system HDT15 will start as soon as possible following randomisation in the Emergency Room (i.e. after vascular neuroimaging), and will be maintained during the transfer to the Angiography Suite, as well as during the entire thrombectomy procedure. HDT15 will end after the completion of mechanical thrombectomy.

    Treatment: HEAD DOWN TILT -10° to -15°

  • USUAL POSITIONINGNo study treatment, for comparison

    Patients randomised in the control group will be maintained in the usual position during the emergency room phase (0° to +30°) and on the angiography table (0°), according to standard practice. Mechanical thrombectomy will be performed as per usual care.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Plain-language title
Head-Down Tilt Positioning Tested in Acute Stroke Patients Before ThrombectomyGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
6 May 2026