Acute Ischemic StrokePISTARNCT06071091
Permanent Intracranial Stenting for Acute Ischemic Stroke Related to a Refractory Large Vessel Occlusion
A study testing Intracranial stenting and Optimal medical care, without additional endovascular procedures in people with Acute Ischemic Stroke, run by Assistance Publique - Hôpitaux de Paris at 13 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Intracranial stenting and Optimal medical care, without additional endovascular procedures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 13 sitesFrance
- Study dates
- 8 Nov 2023to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years
- Acute ischemic stroke secondary to an occlusion of the internal carotid artery termination OR the 1st or 2nd segment of the middle cerebral artery OR the basilar artery and/or the 4th segment of the vertebral artery radiologically proven (CT Angiography or angio-MRI)
- Patient within the authorised timeframe for a MT, according to the AHA/ASA 2019 grade I recommendations
- Refractory intracranial large vessel occlusion defined as :
- Persistent arterial occlusion (mTICI 0 or I) after a minimum of 3 mechanical thrombectomy passes using direct aspiration or a stent retriever OR Early arterial reocclusion (<10 minutes) after at least one pass OR Underlying stenosis (estimated between 70 and 99%)
- ASPECT Score for CT or DWI-ASPECTS for MRI or pc(-DWI)- ASPECTS (posterior circulation) ≥ 5
- Independent patient before stroke (mRS 0-2)
- Patient's or her/his trusted relative's consent or emergency procedure consent
Who cannot join
- Proximal intracranial vascular occlusion not confirmed on angiography
- Intracranial bleeding <3 months or intracranial bleeding during TM procedure prior to inclusion
- Contraindication to a dual antiplatelet therapy
- Mechanical thrombectomy procedure requiring carotid or vertebral arterial access by direct puncture
- Proof of significant ischemic lesions in a vascular territory not affected by the occlusion
- Proven allergy to iodinated contrast material
Show all 13Show fewer
- Patient known for severe renal impairment with creatinine clearance < 30ml/min
- Pregnant or breastfeeding women
- Tandem occlusion (defined as the association of an intracranial occlusion to a cervical steno-occlusive lesion on the same arterial axis that needs additional endovascular manœuvers for the cervical lesion)
- Major comorbidities that could hinder the improvement or the follow up of the patient or the benefit of the intervention
- Unaffiliation to the French Social Security system
- Patient under juridic protection
- Patient participating in another interventional trial
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
CHU Amiens
Amiens, 80054
CHU Bordeaux (Pellegrin Hospital)
Bordeaux, 33000
Henri-Mondor Hospital (APHP)
Créteil, 94000
Henri-Mondor Hospital (APHP)
Créteil, 94010
Bicêtre Hospital (AP-HP)
Le Kremlin-Bicêtre, 94270
Bicêtre Hospital (APHP)
Le Kremlin-Bicêtre, 94270
CHU Lille (Roger Salengro Hospital)
Lille, 59037
CHU Montpellier - Gui de Chauliac
Montpellier, 34295
CHRU de Nancy
Nancy, 54035
Lariboisière Hospital (APHP)
Paris, 75010
APHP • Assistance Publique des Hôpitaux de Paris, Pitié-Salpêtrière hospital
Paris, 75013
CHU Poitiers
Poitiers, 86021
Foch Hospital
Suresnes, 92150
About this study
Official title: Comparison of Permanent Intracranial Stenting Versus no Stenting in Stroke Secondary to Refractory Acute Proximal Vascular Occlusion: a Multicenter Randomized Controlled Trial
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.
Read the detailed description
These past recent years, mechanichal thrombectomy has become the standard treatment for acute ischemic strokes due to large vessel occlusions. Mechanical thrombectomy failure occurs in about 10 to 30% of cases with disastrous consequences for these patients. Indeed, reperfusion failures are associated with 30.5% mortality rates and only 21% of all patients are able to achieve functional independence at 3 months.
In order to treat these refractory large vessel occlusions many techniques and devices have been developped. Rescue Intracranial Stenting (RIS) is the most studied technique and the most promising one. However, RIS requires strong antithrombotic medications to ensure stent patency, which may increase the risk of hemorrhagic complications.
The investigators recently performed a meta-analysis of observational data, that showed that RIS in refractory large vessel occlusions allowed significant improvements in functional outcome at 3 months. The rate of good functional outcome at 3 months went from 21% in the control group (no RIS) to 43% in the RIS group. Mortality was also significantly reduced from 30.5% (control group) to 18.8% in the RIS group. Furthermore, RIS did not increase the rate of symptomatic intracranial hemorrhage.
Of course, this meta-analysis is only based on observational data and needs to be confirmed in a randomized trial to bring the highest level of evidence.
Refractory large vessel occlusions are commonly caused by an underlying intracranial atherosclerotic plaque. Since the SAMMPRIS trial, most of the indications for the endovascular treatment of intracranial atherosclerotic stenoses have been removed. Nevertheless, there are subsets of patients who actually benefit from intracranial stenting such as patients with refractory large vessel occlusions or patients with hemodynamically significant stenoses. As such, the PISTAR trial could be a way of validating intracranial stenting in this indication.
All patients admitted for a mechanical thrombectomy will be screened before the procedure. If the patient fulfills the preoperative elligibility criteria, she/he will be informed of the possibility of being included in case of a refractory occlusion. If the patients' clinical state does not allow her/him to give informed consent, she/he can still be included using an emergency consent procedure. Consents to pursue the study will be sought as soon as possible, from the patient or her/his trusted relative.
If the patient meets all remaining elligibility criteria during the mechanical thrombectomy in particular if the occlusion is considered as refractory, she/he can be included and randomized.
Randomization will be performed using a minimization procedure based on the recruiting center, the administration of IV thrombolysis and the location of the occlusion (anterior versus posterior circulation). The randomzation will be centralized using an online e-crf platform.
The patient can be randomized in one of the two following arms
- Intervention arm : RIS + best medical treatment In this arm, a dedicated antithrombotic protocol will be initiated before the deployment of the stent. The choice of antithrombotics and the need to perform additional endovascular manœuvres such as balloon angioplasty will be left at the operator's discretion. A standard protocol for antithrombotics is proposed.
- Control arm : best medical treatment with no additional thrombectomy passes In this arm, the procedure is stopped and a last control angiogram is performed to confirm the absence of reperfusion. Any additional medical treatment is allowed.
Follow up visits will be performed immediately after the procedure (V0), at 24hrs (V1), 72hs (V2) and 1 month (V3). The end-research visit will be performed at 3 months (+/- 15 days) and a remote safety visit will be performed at 6 months.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Intracranial stenting, Optimal medical care, without additional endovascular procedures
- Keywords
- Brain, Intracranial, Ischemia, Stroke, Mechanical Thrombectomy, Intracranial Occlusion, Refractory Occlusion, Interventional, Angioplasty, Stenting
- Medical subject headings
- Ischemic Stroke, Ischemia, Stroke, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracranial stentingDevice
In order to promote the efficacy of the stent to reopen the target vessel, there are two requirments prior stenting: First, balloon angioplasty can be performed at operators' discretion based on angiographic findings. Second, a dual antiplatelet therapy protocol is considered essential to maintain stent patency, and therefore should be introduced before stent implantation whenever possible.
Permanent Intracranial can then be performed according to the standard technique: An autoexpandable intracranial stent (Neuroform Atlas 4x24mm) is deployed though a dedicated microcatheter over the target refractory occlusion The only stent system allowed is the Neuroform Atlas 4x24mm (Stryker Neurovascular) The anti-thrombotic drugs used, their route of administration, the choice of navigation equipment are left to the discretion of the team in charge of the patient. A standardized anti-thrombotic protocol will be proposed as an indication.
Optimal medical care, without additional endovascular proceduresOther
The control group represents the standard therapeutic strategy for refractory vascular occlusions, which consists of stopping the procedure without performing any additional mechanical thrombectomy attempts.
In this group, the procedure will be stopped after randomization and a control seriography will be performed to confirm the persistent nature of the intracranial occlusion.
The patient will benefit from the best medical care available, which may include any medical treatment including a dual anti-platelet therapy if the therapeutic team deems it necessary (Standard medical care may also include (non-exhaustive list):
- Nursing
- Nursing care
- Symptomatic treatments: analgesics for example
- Systematic clinical monitoring and control imaging if necessary
- Rehabilitation if necessary)
| Study group | Role | What they receive |
|---|---|---|
| Intracranial stenting | Experimental | Rescue Intracranial Stenting + best medical treatment Receives: Device: Intracranial stenting |
| Best medical management alone | Active comparator | Best medical treatment with no additional thrombectomy passes Receives: Other: Optimal medical care, without additional endovascular procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of independent patients
Rate of independent patients at 3 months, defined as a modified Rankin Scale (mRS) 0-2, evaluated by a trained health professional, blinded to the randomization arm.
Min=0 ; Max=6 (lower is better)
Measured: 3 months
Secondary outcomes (24)
Mortality
Mortality rate at 6 months
Measured: 6 months
Excellent functional outcome
Rate of excellent functional prognosis defined as a modified Rankin Scale (mRS) score of 0-1 at 3 months Min=0 ; Max=6 (lower is better)
Measured: 3 months
modified Rankin Scale (mRS)
Distribution of mRS scores at 3 months Min=0 ; Max=6 (lower is better)
Measured: 3 months
Successful reperfusion
Successful reperfusion rate (Score modified Thrombolysis In Cerebral Infarction [mTICI] ≥IIb) Min=0 ; Max=3 (higher is better)
Measured: End of procedure (up to 4 hours)
Excellent reperfusion
Excellent reperfusion rate (defined as modified Thrombolysis In Cerebral Infarction [mTICI] score ≥IIc) Min=0 ; Max=3 (higher is better)
Measured: End of procedure (up to 4 hours)
Symptomatic ischemic recurrence
Rate of symptomatic ischemic recurrence (≥4 points of National Institutes of Health Stroke Scale (NIHSS) compared to the lowest NIHSS score during management) certified by imaging within 3 months.
Min=0 ; Max=42 (lower is better)
Measured: 3 months
Rate of patients requiring a new mechanical thrombectomy
Rate of patients requiring a new mechanical thrombectomy within the group of patients with symtomatic ischemic recurrence
Measured: 3 months
Neurologic recovery
Neurologic recovery at 24 hours, according to the National Institutes of Health Stroke Scale (NIHSS) score as compared to initial NIHSS score Min=0 ; Max=42 (lower is better)
Measured: 24 hours
Neurologic recovery
Neurologic recovery at 72 hours, according to the National Institutes of Health Stroke Scale (NIHSS) score as compared to initial NIHSS score Min=0 ; Max=42 (lower is better)
Measured: 72 hours
Periprocedural time (time between arterial puncture and successful reperfusion (if obtained))
Time between arterial puncture and successful reperfusion (if obtained)
Measured: End of procedure (up to 4 hours)
Periprocedural time (Time between onset of symptoms (or "last seen normal") and successful reperfusion (if obtained))
Time between onset of symptoms (or "last seen normal") and successful reperfusion (if obtained)
Measured: End of procedure (up to 4 hours)
Periprocedural time (Time between randomization and successful reperfusion (if obtained))
Time between randomization and successful reperfusion (if obtained)
Measured: End of procedure (up to 4 hours)
Procedure duration
Time between arterial puncture and arterial closure
Measured: End of procedure (up to 4 hours)
Intracranial hemorrhagic complications
Rate of symptomatic intracranial haemorrhage at 6 months defined as any intracranial haemorrhage responsible for neurological deterioration (≥4 NIHSS points compared to the lowest NIHSS score during management)
Measured: 6 months
Distribution of intracranial hemorrhagic complications
Distribution of intracranial hemorrhagic complications according to the Heidelberg classification
Measured: 6 months
Serious extracranial hemorrhagic complications
Rate of serious extra-cranial hemorrhagic complications at 6 months, defined as any extra-cranial bleeding complication requiring re-hospitalization and/or surgery and/or blood transfusion
Measured: 6 months
All procedural complications
Rate of all procedural complications, including vascular perforation, dissection, embolism in a territory not previously affected by the ischemia and serious complications on the arterial access (as defined below)
Measured: Up to 6 months
Vascular perforation
Rate of vascular perforation during the procedure
Measured: End of procedure (up to 4 hours)
Dissection
Rate of dissection during the procedure
Measured: End of procedure (up to 4 hours)
Embolism in a territory not previously affected by the ischemia
Rate of embolism in a territory not previously affected by the ischemia, during the procedure
Measured: End of procedure (up to 4 hours)
Serious complication on the arterial access
Rate of serious complications on the arterial access, defined as any superficial hematoma with deglobulisation [loss of 2 Hb points on the NFS] and/or requiring a transfusion, retroperitoneal hematoma with or without deglobulisation, arterial pseudo-aneurysm at the puncture site requiring surgical treatment, femoral artery occlusion and/or acute limb ischemia, puncture site abscess.
Measured: 6 months
Vascular reocclusion
Rate of vascular reocclusion on 24-hour imaging
Measured: 24 hours
Adverse events
Rate of adverse events at 6 months
Measured: 6 months
Serious adverse events
Rate of serious adverse events at 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start8 Nov 2023
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 346 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin PREMAT, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06071091
- Sponsor's protocol ID
- APHP210091
- Other IDs
- 2022-A00570-43
- Acronym
- PISTAR
- Status last verified
- Jan 2024
- First submitted
- 4 Sep 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Publications
Premat K, Dechartres A, Baptiste A, Guedon A, Mazighi M, Spelle L, Denier C, Tuilier T, Hosseini H, Lapergue B, Di Maria F, Bricout N, Henon H, Gory B, Richard S, Chivot C, Courselle A, Velasco S, Lamy M, Costalat V, Arquizan C, Marnat G, Sibon I, Lenck S, Shotar E, Allard J, Sourour N, Degos V, Alamowitch S, Clarencon F. Comparison of rescue intracranial stenting versus best medical treatment alone in acute refractory large vessel occlusion: study protocol for the PISTAR multicenter randomized trial. J Neurointerv Surg. 2025 Mar 17;17(4):360-367. doi: 10.1136/jnis-2024-021502.
PubMed 38538057
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Permanent Intracranial Stenting Versus no Stenting in Stroke Secondary to Refractory Acute Proximal Vascular Occlusion: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06071091
- Acronym / sponsor ID
- PISTAR / APHP210091
- Conditions
- Acute Ischemic Stroke
- Keywords
- Brain, Intracranial, Ischemia, Stroke, Mechanical Thrombectomy, Intracranial Occlusion, Refractory Occlusion, Interventional
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 346 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 8 Nov 2023 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
These past recent years, mechanichal thrombectomy has become the standard treatment for acute ischemic strokes due to large vessel occlusions. Mechanical thrombectomy failure occurs in about 10 to 30% of cases with disastrous consequences for these patients. Indeed, reperfusion failures are associated with 30.5% mortality rates and only 21% of all patients are able to achieve functional independence at 3 months.
In order to treat these refractory large vessel occlusions many techniques and devices have been developped. Rescue Intracranial Stenting (RIS) is the most studied technique and the most promising one. However, RIS requires strong antithrombotic medications to ensure stent patency, which may increase the risk of hemorrhagic complications.
The investigators recently performed a meta-analysis of observational data, that showed that RIS in refractory large vessel occlusions allowed significant improvements in functional outcome at 3 months. The rate of good functional outcome at 3 months went from 21% in the control group (no RIS) to 43% in the RIS group. Mortality was also significantly reduced from 30.5% (control group) to 18.8% in the RIS group. Furthermore, RIS did not increase the rate of symptomatic intracranial hemorrhage.
Of course, this meta-analysis is only based on observational data and needs to be confirmed in a randomized trial to bring the highest level of evidence.
Refractory large vessel occlusions are commonly caused by an underlying intracranial atherosclerotic plaque. Since the SAMMPRIS trial, most of the indications for the endovascular treatment of intracranial atherosclerotic stenoses have been removed. Nevertheless, there are subsets of patients who actually benefit from intracranial stenting such as patients with refractory large vessel occlusions or patients with hemodynamically significant stenoses. As such, the PISTAR trial could be a way of validating intracranial stenting in this indication.
All patients admitted for a mechanical thrombectomy will be screened before the procedure. If the patient fulfills the preoperative elligibility criteria, she/he will be informed of the possibility of being included in case of a refractory occlusion. If the patients' clinical state does not allow her/him to give informed consent, she/he can still be included using an emergency consent procedure. Consents to pursue the study will be sought as soon as possible, from the patient or her/his trusted relative.
If the patient meets all remaining elligibility criteria during the mechanical thrombectomy in particular if the occlusion is considered as refractory, she/he can be included and randomized.
Randomization will be performed using a minimization procedure based on the recruiting center, the administration of IV thrombolysis and the location of the occlusion (anterior versus posterior circulation). The randomzation will be centralized using an online e-crf platform.
The patient can be randomized in one of the two following arms
- Intervention arm : RIS + best medical treatment In this arm, a dedicated antithrombotic protocol will be initiated before the deployment of the stent. The choice of antithrombotics and the need to perform additional endovascular manœuvres such as balloon angioplasty will be left at the operator's discretion. A standard protocol for antithrombotics is proposed.
- Control arm : best medical treatment with no additional thrombectomy passes In this arm, the procedure is stopped and a last control angiogram is performed to confirm the absence of reperfusion. Any additional medical treatment is allowed.
Follow up visits will be performed immediately after the procedure (V0), at 24hrs (V1), 72hs (V2) and 1 month (V3). The end-research visit will be performed at 3 months (+/- 15 days) and a remote safety visit will be performed at 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracranial stenting | Experimental | Device: Intracranial stentingRescue Intracranial Stenting + best medical treatment |
| Best medical management alone | Active comparator | Other: Optimal medical care, without additional endovascular proceduresBest medical treatment with no additional thrombectomy passes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age>18 years
- Acute ischemic stroke secondary to an occlusion of the internal carotid artery termination OR the 1st or 2nd segment of the middle cerebral artery OR the basilar artery and/or the 4th segment of the vertebral artery radiologically proven (CT Angiography or angio-MRI)
- Patient within the authorised timeframe for a MT, according to the AHA/ASA 2019 grade I recommendations
- Refractory intracranial large vessel occlusion defined as :
- Persistent arterial occlusion (mTICI 0 or I) after a minimum of 3 mechanical thrombectomy passes using direct aspiration or a stent retriever OR Early arterial reocclusion (<10 minutes) after at least one pass OR Underlying stenosis (estimated between 70 and 99%)
Key exclusion criteria (13 listed)
- Proximal intracranial vascular occlusion not confirmed on angiography
- Intracranial bleeding <3 months or intracranial bleeding during TM procedure prior to inclusion
- Contraindication to a dual antiplatelet therapy
- Mechanical thrombectomy procedure requiring carotid or vertebral arterial access by direct puncture
- Proof of significant ischemic lesions in a vascular territory not affected by the occlusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracranial stentingIn order to promote the efficacy of the stent to reopen the target vessel, there are two requirments prior stenting: First, balloon angioplasty can be performed at operators' discretion based on angiographic findings. Second, a dual antiplatelet therapy protocol is considered essential to maintain stent patency, and therefore should be introduced before stent implantation whenever possible. Permanent Intracranial can then be performed according to the standard technique: An autoexpandable intracranial stent (Neuroform Atlas 4x24mm) is deployed though a dedicated microcatheter over the target refractory occlusion The only stent system allowed is the Neuroform Atlas 4x24mm (Stryker Neurovascular) The anti-thrombotic drugs used, their route of administration, the choice of navigation equipment are left to the discretion of the team in charge of the patient. A standardized anti-thrombotic protocol will be proposed as an indication. | Device | Intracranial stenting |
| Optimal medical care, without additional endovascular proceduresThe control group represents the standard therapeutic strategy for refractory vascular occlusions, which consists of stopping the procedure without performing any additional mechanical thrombectomy attempts. In this group, the procedure will be stopped after randomization and a control seriography will be performed to confirm the persistent nature of the intracranial occlusion. The patient will benefit from the best medical care available, which may include any medical treatment including a dual anti-platelet therapy if the therapeutic team deems it necessary (Standard medical care may also include (non-exhaustive list): * Nursing * Nursing care * Symptomatic treatments: analgesics for example * Systematic clinical monitoring and control imaging if necessary * Rehabilitation if necessary) | Other | Best medical management alone |
Primary outcome
Rate of independent patients
Time frame: 3 months
Rate of independent patients at 3 months, defined as a modified Rankin Scale (mRS) 0-2, evaluated by a trained health professional, blinded to the randomization arm. Min=0 ; Max=6 (lower is better)
24 secondary outcomes
Mortality
Time frame: 6 months
Excellent functional outcome
Time frame: 3 months
modified Rankin Scale (mRS)
Time frame: 3 months
Successful reperfusion
Time frame: End of procedure (up to 4 hours)
Excellent reperfusion
Time frame: End of procedure (up to 4 hours)
Symptomatic ischemic recurrence
Time frame: 3 months
Rate of patients requiring a new mechanical thrombectomy
Time frame: 3 months
Neurologic recovery
Time frame: 24 hours
Neurologic recovery
Time frame: 72 hours
Periprocedural time (time between arterial puncture and successful reperfusion (if obtained))
Time frame: End of procedure (up to 4 hours)
Periprocedural time (Time between onset of symptoms (or "last seen normal") and successful reperfusion (if obtained))
Time frame: End of procedure (up to 4 hours)
Periprocedural time (Time between randomization and successful reperfusion (if obtained))
Time frame: End of procedure (up to 4 hours)
Procedure duration
Time frame: End of procedure (up to 4 hours)
Intracranial hemorrhagic complications
Time frame: 6 months
Distribution of intracranial hemorrhagic complications
Time frame: 6 months
Serious extracranial hemorrhagic complications
Time frame: 6 months
All procedural complications
Time frame: Up to 6 months
Vascular perforation
Time frame: End of procedure (up to 4 hours)
Dissection
Time frame: End of procedure (up to 4 hours)
Embolism in a territory not previously affected by the ischemia
Time frame: End of procedure (up to 4 hours)
Serious complication on the arterial access
Time frame: 6 months
Vascular reocclusion
Time frame: 24 hours
Adverse events
Time frame: 6 months
Serious adverse events
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Derived from this study: PubMed 38538057Premat K, Dechartres A, Baptiste A, Guedon A, Mazighi M, Spelle L, Denier C, Tuilier T, Hosseini H, Lapergue B, Di Maria F, Bricout N, Henon H, Gory B, Richard S, Chivot C, Courselle A, Velasco S, Lamy M, Costalat V, Arquizan C, Marnat G, Sibon I, Lenck S, Shotar E, Allard J, Sourour N, Degos V, Alamowitch S, Clarencon F. Comparison of rescue intracranial stenting versus best medical treatment alone in acute refractory large vessel occlusion: study protocol for the PISTAR multicenter randomized trial. J Neurointerv Surg. 2025 Mar 17;17(4):360-367. doi: 10.1136/jnis-2024-021502.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin PREMAT, MD principal investigator
Assistance Publique - Hôpitaux de Paris
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracranial stenting and Optimal medical care, without additional endovascular procedures in people with Acute Ischemic Stroke, run by Assistance Publique - Hôpitaux de Paris at 13 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of independent patients (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06071091, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.