Advancing Reperfusion Therapy for Ischemic Stroke: Perfusion-guided Endovascular Intervention for Medium Vessel Occlusion Therapy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Tiantan Hospital

About this trial

The investigators initiated a multicenter, prospective, randomized, open label, blinded-endpoint (PROBE) controlled trial to evaluate the efficacy and safety of perfusion-guided endovascular treatment (EVT) compared to standard medical care for patients with acute ischemic stroke due to medium vessel occlusion (MeVO) within 24 hours from symptom onset.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age≥18 years old;

Acute ischemic stroke symptom onset within 24 hours; including wake-up stroke and unwitnessed stroke, onset time refers to "last-seen normal time";

Primary medium vessel occlusions confirmed by CTA/MRA, including non-dominant proximal M2 or mid-distal M2/M3 segments of the middle cerebral artery (MCA), A1/A2/A3 segments of the anterior cerebral artery (ACA), and P1/P2/P3 segments of the posterior cerebral artery (PCA) and responsible for the signs and symptoms of acute ischemic stroke;

Pre-stroke modified Rankin scale (mRS) score ≤1;

Disqualifiers

Any evidence of intracranial hemorrhage on qualifying imaging;

Known (serious) sensitivity to radiographic contrast agents, nickel, titanium metals or their alloys and unable to complete CTP/PWI;

Known history of arterial tortuosity, pre-existing stent, other arterial disease and/or known disease at the arterial access site that would prevent the device from reaching the target vessel and/or preclude safe recovery after EVT;

Radiological confirmed evidence of mass effect or intracranial tumour (except small meningioma);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Endovascular treatment

    Procedure/Surgery

    EVT included thrombectomy with stent retrievers, thromboaspiration, intraarterial thrombolysis, balloon angioplasty, stenting, or a combination of these approaches at the discretion of the interventional team.

  • Best medical treatment (BMT)

    Drug

    Administration of BMT should be done according to routine clinical practice and current international guidelines. Administration of BMT must not be delayed by randomisation and should be done independently from participation in this trial.

Treatment groups

568 Participants
are divided into 2 treatment groups
Group A: Endovascular treatment (EVT) +Best medical treatmentExperimental treatment 1 intervention
Group B: Best medical treatment (BMT)Other 1 intervention

Trial outcomes

Primary outcomes

1

The proportion of patients who have a score of 0 or 1 on the modified Rankin Scale (mRS) at 90 days

The proportion of patients with an mRS score ≤ 1 at 90 days. The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.

Time frame
90 days

Secondary outcomes

1

Ordinal distribution of modified Rankin Scale (mRS) at 90 days

Ordinal distribution of mRS at 90 days (shift analysis). The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.

Time frame
90 days
2

The proportion of patients with an modified Rankin Scale (mRS) score of 0-2 at 90 days

The proportion of patients with an mRS score of 0-2 at 90 days. The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.

Time frame
90 days
3

The rate of early neurological improvement at 24 hours

The rate of early neurological improvement at 24 hours after randomization (defined as a National Institute of Health Stroke Scale \[NIHSS\] score ≤1 or ≥4 points compared with the baseline)

Time frame
24 hours
4

The proportion of patients with an modified Rankin Scale (mRS) score of 5-6 at 90 days

The proportion of patients with an mRS score of 0-2 at 90 days. The mRS score is a seven-point ordered categorical scale from 0 to 6 for functional neurological outcome, with 0 indicating no neurological symptoms and 6 indicating death.

Time frame
90 days

Other outcomes

1

The proportion of successful recanalization

The proportion of successful recanalization(eTICI 2b50-3) following EVT

Time frame
immediately after the intervention
2

The proportion of improvement on reperfusion at 24 hours after randomization

Improvement on reperfusion is defined as \>90% reduction in Tmax \> 6s lesion volume

Time frame
24 hours
3

The proportion of complete recanalization at 24 hours after randomization

Complete recanalization is defined as an Arterial Occlusion Lesion scale \[AOL\] score of 3 (scale range, 0 \[no recanalization\] to 3 \[complete recanalization\]).

Time frame
24 hours

Sponsors and contacts

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