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

Primary Purpose

Acute Ischemic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
endovascular recanalization via radial approach
endovascular recanalization via femoral approach
Sponsored by
Jinling Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Baseline NIHSS score ≥ 10 before randomization. Intact dual circulation of the hand assessed by the modified Allen's test. Written informed consent from patients or their legally authorized representatives. Exclusion Criteria: Pre-stroke disability with mRS score ≥ 3. Pregnant or lactating women. Allergic to contrast agents or nitinol devices. Participation in other clinical trials. Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110mmHg, and can not be controlled by antihypertensive drugs. Known genetic or acquired bleeding diathesis, lack of coagulation factors; or oral anticoagulant therapy with INR > 1.7. 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%. Life expectancy less than 1 year. Lost to follow-up within 90 days (e.g. no fixed residence, overseas patients, etc.). Acute ischemic stroke within 48 hours after percutaneous coronary intervention, cerebrovascular intervention, or major surgery (patients can be included if more than 48 hours). Clinical manifestations of central nervous system vasculitis. Premorbid nervous system diseases or mental disorders hindering the assessment of the disease. 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.

Sites / Locations

  • Department of Neurology, Jinling HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

the radial group

the femoral group

Arm Description

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

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

Outcomes

Primary Outcome Measures

favorable neurological function
favorable neurological function (defined as mRS score ≤ 3)

Secondary Outcome Measures

Procedure time
Procedure time of the endovascular thrombectomy

Full Information

First Posted
June 6, 2023
Last Updated
July 27, 2023
Sponsor
Jinling Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT05903560
Brief Title
Radial Versus Femoral Access For Thrombectomy in Patients With Acute Basilar Artery Occlusion
Official Title
Radial Versus Femoral Access For Thrombectomy in Patients With Acute Basilar Artery Occlusion
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 22, 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jinling Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
386 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the radial group
Arm Type
Experimental
Arm Description
Patients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via radial approach randomly
Arm Title
the femoral group
Arm Type
Active Comparator
Arm Description
Patients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via femoral approach randomly
Intervention Type
Procedure
Intervention Name(s)
endovascular recanalization via radial approach
Intervention Description
Patients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via radial approach
Intervention Type
Procedure
Intervention Name(s)
endovascular recanalization via femoral approach
Intervention Description
Patients with basilar artery occlusion within 24 hours of onset will be chosen to receive endovascular recanalization via femoral approach
Primary Outcome Measure Information:
Title
favorable neurological function
Description
favorable neurological function (defined as mRS score ≤ 3)
Time Frame
at 90 days post-operation
Secondary Outcome Measure Information:
Title
Procedure time
Description
Procedure time of the endovascular thrombectomy
Time Frame
at the operation 1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Baseline NIHSS score ≥ 10 before randomization. Intact dual circulation of the hand assessed by the modified Allen's test. Written informed consent from patients or their legally authorized representatives. Exclusion Criteria: Pre-stroke disability with mRS score ≥ 3. Pregnant or lactating women. Allergic to contrast agents or nitinol devices. Participation in other clinical trials. Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110mmHg, and can not be controlled by antihypertensive drugs. Known genetic or acquired bleeding diathesis, lack of coagulation factors; or oral anticoagulant therapy with INR > 1.7. 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%. Life expectancy less than 1 year. Lost to follow-up within 90 days (e.g. no fixed residence, overseas patients, etc.). Acute ischemic stroke within 48 hours after percutaneous coronary intervention, cerebrovascular intervention, or major surgery (patients can be included if more than 48 hours). Clinical manifestations of central nervous system vasculitis. Premorbid nervous system diseases or mental disorders hindering the assessment of the disease. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rui Liu, MD
Phone
+86 2584801861
Email
liurui8616@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xinfeng Liu, MD
Phone
+86 2584801861
Email
xfliu2@vip.163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xinfeng Liu, MD
Organizational Affiliation
Department of Neurology, Jinling Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurology, Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinfeng Liu, MD
Phone
02580860124
Email
xfliu2@vip.163.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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