NCT06071091: PISTAR

Permanent Intracranial Stenting for Acute Ischemic Stroke Related to a Refractory Large Vessel Occlusion

Active, enrolled NA Last updated 9 January 2024

What this trial tests

NA trial testing Intracranial stenting in Acute Ischemic Stroke in 346 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

8 November 2023

Primary endpoint
1 February 2027

1 August 2027

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	346
Start date	8 November 2023
Primary completion	1 February 2027
Estimated completion	1 August 2027
Sites	13 locations across France

Drugs / interventions tested

• Intracranial stenting
• Optimal medical care, without additional endovascular procedures

Conditions studied

• Acute Ischemic Stroke — all drugs for Acute Ischemic Stroke →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Acute Ischemic Stroke. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Clot extraction failure during mechanical thrombectomy is a major concern in the management of acute ischemic stroke related to large vessel occlusions. Indeed, it can occur in up to 10 to 30% of cases and, therefore, is associated with a very poor prognosis. These refractory occlusions frequently occur when an underlying intracranial atherosclerotic disease is present. Thus, one of the most promising rescue technique consists of placing a permanent intracranial stent, under dual antiplatelet therapy over the target refractory occlusion. This strategy is well studied in coronary occlusions where the atheroscotic mechanism is highly prevalent. However, as the ischemiated brain is at much higher risk of hemorrhagic complications, such strategy entails a greater risk. This raises the question of whether such risk is worth the reward of obtaining reperfusion. The investigators designed this randomized study in order to evaluate whether a strategy combining rescue pemanent intracranial stenting with the best medical treatment is superior to the best medical treatment alone in acute refractory large vessel occlusions.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comparison of rescue intracranial stenting versus best medical treatment alone in acute refractory large vessel occlusion: study protocol for the PISTAR multicenter randomized trial.
   Premat K, Dechartres A, Baptiste A, Guedon A, et al · · 2025 · cited 4× · PMID 38538057 · DOI 10.1136/jnis-2024-021502
2. Unmet Needs in Acute Ischemic Stroke: Overcoming Recalcitrant Clots.
   Mirza M, Ulfert C, Ulfert C, McCarthy R, et al · · 2025 · PMID 40576345 · DOI 10.1097/crd.0000000000000977