Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06297863

Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke

Led by University of Milano Bicocca · Updated on 2026-05-06

118

Participants Needed

6

Research Sites

95 weeks

Total Duration

On this page

Sponsors

U

University of Milano Bicocca

Lead Sponsor

F

Fondazione IRCCS San Gerardo dei Tintori

Collaborating Sponsor

AI-Summary

What this Trial Is About

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°).

CONDITIONS

Official Title

Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 6 locations

1

Ospedale Civile SS. Nicola e Filippo Avezzano Pronto Soccorso

Avezzano, Italy, 67051

Not Yet Recruiting

2

Azienda Ospedaliero Universitaria Careggi

Florence, Italy, 50134

Not Yet Recruiting

3

Azienda Ospedaliera Policlinico Universitario "G. Martino"

Messina, Italy, 98124

Not Yet Recruiting

4

Fondazione IRCCS San Gerardo dei Tintori Monza

Monza, Italy, 20900

Actively Recruiting

5

Azienda Ospedaliero Universitaria Policlinico Umberto I

Roma, Italy, 00161

Not Yet Recruiting

6

Ospedale Santa Maria della Misericordia

Udine, Italy, 33100

Not Yet Recruiting

Loading map...

Research Team

S

Simone Beretta, MD, PhD

CONTACT

B

BiCRO (academic CRO)

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here