Intracranial Thrombosis Aspiration Catheter for Recanalization in Acute Ischemic Stroke Therapy (RECOVER)

Not Applicable

• Conditions: Large Vessel Occlusion; Acute Ischemic Stroke; Cerebrovascular Disorders
• Interventions: Device: Aspiration Catheter; Device: Solitaire FR

• Registration Number: NCT03753061
• Lead Sponsor: Ministry of Science and Technology of the People´s Republic of China

Brief Summary

This study is a prospective, multi-center, open-label, end-point blinded, randomized, parallel positive control, non-inferiority clinical trial, with a purpose to evaluate the safety and efficacy of Hemo Jirui intracranial thrombus aspiration catheter system for endovascular treatment of acute ischemic stroke by comparison with stent retriever (Solitaire FR). The trial is anticipated to last from November 2018 to May 2019, with 204 subjects recruited from 15-20 clinical trial centers in China.

Detailed Description

This study is a prospective, multi-center, open-label, end-point blinded, parallel positive controlled, non-inferiority clinical trial. Patients with acute ischemic stroke (AIS) who meet inclusion criteria would be enrolled in this study. Led by Beijing Tiantan Hospital affiliated to Capital Medical University, this study is planned to be carried out in 15-20 clinical trial institutions in China. There will be 102 patients enrolled in each group. Patients in the experimental group will be treated with the intracranial thrombus aspiration catheter, product of Hemo Jirui. Patients in the control group will be treated with stent retriever (Solitaire FR).

In this trial, relevant examinations of safety and efficacy assessments were performed immediately after the procedure, at 24 hours, 7 days, 30 days, and 90 days. Primary efficacy endpoint will be the immediate recanalization rate (mTICI 2b-3) of target vessel after the procedure. Secondary efficacy endpoints will include: (1) Proportion of functional independence (mRS 0-2) at 90 days; (2) ordinal shift analysis of mRS at 90 days; (3) immediate recanalization rate (mTICI 2b-3) of the first pass of thrombectomy device; (4) immediate recanalization rate (mTICI 2b-3) of the last pass of thrombectomy device; (5)procedure time (randomization to recanalization); (6) Change in NIHSS score at 24hours; (7) Change in NIHSS score at 7 days or discharge (whichever comes first); (8) mTICI grading of target vessel revealed by CTA or MRA at 22-36 hours; (9) The extent of anterior circulation infarction at 22-36 hours, as measured by ASPECTS on CT or MRI. Safety endpoints will include: (1) All-cause mortality at 90 days; (2) stroke-related mortality at 90 days; (3) stroke recurrence rate within 90 days; (4) any type of intracranial hemorrhagic transformation within 22-36 hours, including parenchymal, subarachnoid or ventricular hemorrhage; (5) symptomatic intracranial hemorrhage (sICH) within 22-36 hours, as confirmed by any intracranial hemorrhage on CT or MRI associated with ≥ 4 points of worsening on NIHSS or even contributing to death; (5) procedural complications or serious adverse events procedural complications or serious adverse events (SAEs) within 90 days.

The trial is anticipated to last from November 2018 to May 2019, all the related investigative organization and individuals will obey the Declaration of Helsinki and Chinese Good Clinical Practice standard. The trial has been approved by Institutional Review Board (IRB) and Ethics Committee(EC) in Being Tiantan hospital, Capital Medical University.

Study Timeline

• Study First Submitted: 2018-11-21
• Study Start: 2018-11-22
• Study First Submitted QC: 2018-11-23
• Study First Posted: 2018-11-26
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19
• Primary Completion: 2020-03-20
• Study Completion: 2020-03-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

1. Age ≥ 18 years.
2. Symptoms and signs in accordance with anterior circulation ischemia and large vessel occlusion (ICA, MCA-M1 or M2) confirmed by CTA/MRA/DSA.
3. Pre-stroke Modified Rankin Scale（mRS）0-1.
4. NIHSS score ≥ 6 points at time of randomization.
5. The patients should receive endovascular treatment within 8 hours of estimated time of large vessel occlusion (LVO) onset, and have an ASPECTS ≥ 6 points on non-enhanced CT.
6. If intravenous thrombolysis with tPA (IVT) is considered as part of standard medical management, IVT should be started within 4.5 hours of estimated time of LVO. Furthermore, in AIS patients with an unknown time of onset, IVT guided by a mismatch between DWI and FLAIR in the region of ischemia is also recommended.
7. Written informed consent obtained from patient or patient's legally authorized representative.

Exclusion Criteria

1. Acute posterior circulation cerebral infarction comfirmed by CT or MRI.
2. Any type of cerebral hemorrhage (only microbleeds are allowed) on neuroimaging.
3. Large (more than one-third of the MCA) regions of clear hypodensity on the baseline CT scan or ASPECTS < 7 points or significant mass effect with midline shift.
4. Proven occlusion of the common carotid artery.
5. Known or suspected chronic occlusion of target vessel.
6. Known life threatening allergy (more than rash) to iodinated contrast agent.
7. Arterial tortuosity and other problems that would prevent the device from reaching the target vessel.
8. Known hereditary or acquired hemorrhagic diathesis, coagulation factor deficiency.
9. Baseline platelet count < 50000/µL.
10. Severe heart, liver or kidney failure and other serious or terminal illness.
11. Major surgery within the past 2 weeks
12. Haemorrhage of the gastrointestinal or urinary tract within the past 3 weeks.
13. Baseline blood glucose < 2.7 or > 22.2 mmol/L.
14. Baseline blood pressure > 185/110 mmHg, or aggressive treatment (intravenous medication) necessary to reduce blood pressure to these limits
15. Pregnant or lactating or positive pregnancy test on admission.
16. Dementia or psychiatric disease that would confound the neurological or functional evaluations.
17. Life expectancy less than 1 year.
18. Current participation in another drug or device research.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspiration Catheter	Aspiration Catheter	Mechanical thrombectomy with Aspiration Catheter.
Stent Retriever (Solitaire FR)	Solitaire FR	Mechanical thrombectomy with Solitaire FR.

Primary Outcome Measures

Name	Time	Method
Instant recanalization rate (mTICI 2b-3) of target vessel after the procedure	immediate

Secondary Outcome Measures

Name	Time	Method
Instant recanalization rate (mTICI 2b-3) after the first thrombectomy	immediate
Instant recanalization rate (mTICI 2b-3) after the last thrombectomy	immediate
The extent of anterior circulation infarction at 22-36 hours, as measured by ASPECTS on CT or MRI	22-36 hours
Procedure time (randomization to recanalization)	procedure
Proportion of functional independence (mRS 0-2) at 90 days	90 days
Change in NIHSS score at 24±2 hours	24 hours
mTICI grading of target vessel revealed by CTA or MRA at 22-36 hours	22-36 hours
Ordinal shift analysis of mRS at 90 days	90 days
Change in NIHSS score at 7±1 days or discharge (whichever comes first)	7 days

Trial Locations

Locations (23)

Luoyang Central Hospital; 🇨🇳 Luoyang, Henan, China

Affiliated Hospital of Hebei University; 🇨🇳 Baoding, Hebei, China

Zhengzhou Central Hospital; 🇨🇳 Zhengzhou, Henan, China

Taihe Hospital; 🇨🇳 Shiyan, Hubei, China

Tangshan People's Hospital; 🇨🇳 Tangshan, Hebei, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Yantaishan Hospital; 🇨🇳 Yantai, Shandong, China

Baotou Central Hospital; 🇨🇳 Baotou, Neimenggu, China

Weihai Central Hospital; 🇨🇳 Weihai, Shandong, China

Tangdu Hospital; 🇨🇳 Xi'an, Shaanxi, China

Henan Province People's Hospital; 🇨🇳 Zhengzhou, Henan, China

The Affiliated Hospital of Xuzhou Medical University; 🇨🇳 Xuzhou, Jiangsu, China

Liaocheng People's Hospital; 🇨🇳 Liaocheng, Shandong, China

Qingdao Central Hospital; 🇨🇳 Qingdao, Shandong, China

Tianjin First Central Hospital; 🇨🇳 Tianjin, Tianjin, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, Tianjin, China

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Luhe Hospital Medical University; 🇨🇳 Beijing, Beijing, China

The Second Affiliated Hospital of Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China

The First Affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China

First Hospital of Shanxi Medical University; 🇨🇳 Taiyuan, Shanxi, China