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

NCT ID: NCT05903560

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 386 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-22
• Study Completion Date: 2025-09-30

Brief Summary

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

the radial group

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

Group Type: EXPERIMENTAL

endovascular recanalization via radial approach

Intervention Type: PROCEDURE

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

the femoral group

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

Group Type: ACTIVE_COMPARATOR

endovascular recanalization via femoral approach

Intervention Type: PROCEDURE

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

Interventions

endovascular recanalization via radial approach

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

Intervention Type: PROCEDURE

endovascular recanalization via femoral approach

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

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

3. Age ≥ 18 years.

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

5. Baseline NIHSS score ≥ 10 before randomization.

6. Intact dual circulation of the hand assessed by the modified Allen's test.

7. Written informed consent from patients or their legally authorized representatives.

Exclusion Criteria

1. Pre-stroke disability with mRS score ≥ 3.

2. Pregnant or lactating women.

3. Allergic to contrast agents or nitinol devices.

4. Participation in other clinical trials.

5. Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110mmHg, and can not be controlled by antihypertensive drugs.

6. Known genetic or acquired bleeding diathesis, lack of coagulation factors; or oral anticoagulant therapy with INR > 1.7.

7. Baseline lab values: blood glucose < 50mg/dL (2.8mmol/L) or > 400mg/dL (22.2 mmol/L), platelet count < 50*109 /L, or hematocrit < 25%.

8. Life expectancy less than 1 year.

9. Lost to follow-up within 90 days (e.g. no fixed residence, overseas patients, etc.).

10. Acute ischemic stroke within 48 hours after percutaneous coronary intervention, cerebrovascular intervention, or major surgery (patients can be included if more than 48 hours).

11. Clinical manifestations of central nervous system vasculitis.

12. Premorbid nervous system diseases or mental disorders hindering the assessment of the disease.

13. Diseases or anatomical abnormalities that make it difficult for radial or femoral artery puncture, sheath insertion or instrument delivery, such as local infection, anatomical abnormalities confirmed by ultrasound or other imaging examinations, previous interventional or open surgery.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinling Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Xinfeng Liu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xinfeng Liu, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Jinling Hospital, China

Locations

Department of Neurology, Jinling Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Rui Liu, MD

Role: CONTACT

liurui8616@163.com

+86 2584801861

Xinfeng Liu, MD

Role: CONTACT

xfliu2@vip.163.com

+86 2584801861

Facility Contacts

Xinfeng Liu, MD

Role: primary

xfliu2@vip.163.com

02580860124

Other Identifiers

RACE-BAO

Identifier Type: -

Identifier Source: org_study_id