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Head Down Tilt 15° to Increase Collateral Flow in Acute Ischemic Stroke - Trial NCT06297863

Access comprehensive clinical trial information for NCT06297863 through Pure Global AI's free database. This Phase 2 trial is sponsored by University of Milano Bicocca and is currently Not yet recruiting. The study focuses on Acute Ischemic Stroke. Target enrollment is 118 participants.

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NCT06297863
Phase 2
Not yet recruiting
procedure
Trial Details
ClinicalTrials.govNCT06297863
View on ClinicalTrials.gov
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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

Study Focus

Acute Ischemic Stroke

HEAD DOWN TILT -10° to -15°

Interventional

procedure

Sponsor & Location

University of Milano Bicocca

Timeline & Enrollment

Phase 2

Oct 01, 2024

Dec 31, 2026

118 participants

Primary Outcome

Good collateral status

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°).

ICD-10 Classifications

Stroke, not specified as haemorrhage or infarction
Sequelae of stroke, not specified as haemorrhage or infarction
Cerebral infarction
Cerebral infarction, unspecified
Transient cerebral ischaemic attack, unspecified

Data Source

ClinicalTrials.gov

NCT06297863

Non-Device Trial