Radial Versus Femoral Access For Thrombectomy in Patients With Acute Basilar Artery Occlusion

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJinling Hospital, China

About this trial

Stroke is one of the most important diseases endangering the health and quality of life of Chinese people. Acute ischemic stroke (AIS) is commonly caused by cerebrovascular stenosis or occlusion. The most effective treatment for AIS is timely and successful angiographic reperfusion.

Due to the large diameter and obvious positioning of bilateral femoral arteries, the transfemoral artery (TFA) using Seldinger's technique has been the most commonly used approach for endovascular treatment. However, recent studies have suggested that the radial artery is an ideal puncture site for cerebrovascular intervention. Small sample studies have confirmed that endovascular recanalization for acute anterior circulation large vessel occlusion via TRA has been safe and effective. Still, there are some complex approaches needed to be converted to TFA. There has been no difference in total operation duration and fluoroscopy time between TRA and TFA, but the TRA group had higher radiation dose and shorter hospital stays than the TFA group. In addition, TRA tends to be more convenient than TFA, especially for posterior circulation lesions.

However, the current studies are based on a single center with a small sample size, and there has been still a lack of large-sample randomized controlled experiments to verify the safety and effectiveness of posterior endovascular recanalization via TRA.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Acute ischemic stroke in the posterior circulation confirmed by symptoms and imaging examinations.

Basilar artery occlusion confirmed by computed tomographic angiography (CTA), magnetic resonance angiography (MRA), or digital subtraction angiography (DSA).

Age ≥ 18 years.

Time from symptom onset to randomization within 24 hours of the estimated time of basilar artery occlusion.

Disqualifiers

Pre-stroke disability with mRS score ≥ 3.

Pregnant or lactating women.

Allergic to contrast agents or nitinol devices.

Participation in other clinical trials.

Trial design

Design model

Parallel

Treatments tested in this trial

  • endovascular recanalization via radial approach

    Procedure/Surgery

    Patients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via radial approach

  • endovascular recanalization via femoral approach

    Procedure/Surgery

    Patients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via femoral approach

Treatment groups

386 Participants
are divided into 2 treatment groups
Group A: the radial groupExperimental treatment 1 intervention
Group B: the femoral groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The proportion of favorable neurological function at 90 days (defined as mRS score ≤ 3)

mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome)

Time frame
90 days after randomization

Secondary outcomes

1

Procedure time

Procedure time of the endovascular thrombectomy

Time frame
immediately after procedure
2

The proportion of mRS score 0-2 at 90 days

mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).

Time frame
90 days after randomization
3

Ordinal distribution of mRS score at 90 days

mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).

Time frame
90 days after randomization
4

Ordinal shift analysis of mRS at 90 days

mRS is short for modified Ranking score (ranging from 0 to 6, with higher values indicating a worse functional outcome).

Time frame
90 days after randomization

Other outcomes

1

The rate of successful cerebrovascular angiography

Whether the diagnostic cerebrovascular angiography is finished successfully.

Time frame
immediately after procedure
2

The rate of successful vascular recanalization (defined as mTICI 2b/c)

mTICI is short for modified Thrombolysis in cerebral Infarction (ranging from 0 to 3, with higher values indicating a better reperfusion state).

Time frame
Immediately after the thrombectomy procedure is completed
3

Time to first ambulation

The time until the patient could walk after the operation.

Time frame
within 90 days after randomization
4

X-ray radiation dose

Radiation dose during the operation.

Time frame
immediately after procedure

Sponsors and contacts

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