Acute Ischemic StrokeEnTRIPSNCT04581759
Endovascular Treatment and RIPC in Acute Ischemic Stroke
A study testing RIPC device (IPC-906X) and foundational treatment in people with Acute Ischemic Stroke and Endovascular Treatment, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
Endovascular treatment（ET）is an effective therapy for acute ischemic stroke(AIS) with great vessel obstruction. However, acute complications such as high postoperative perfusion injury, hemorrhagic transformation and restenosis resulted in functional independence in only about 50% of patients 90 days after… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke, Endovascular Treatment
- What is being tested?
- RIPC device (IPC-906X) and foundational treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2021to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acute ischemic stroke（AIS） patients with large vessel occlusion (internal carotid artery system and vertebral basilar artery system) within 24 hours after onset, endovascular treatment (mechanical thrombotomy, intra-arterial thrombolysis, balloon dilatation or stent angioplastyand) successful opening were performed, and the definition of successful opening was defined by Modified Thrombolysis standard [Modified Thrombolysis in Cerebral infarction, mTICI]≥ 2B，The standards of endovascular interventional treatment are in line with the indications and contraindications formulated in the Chinese Guidelines for the Early Treatment of Acute Ischemic Stroke 2018；
- Modified Rankin scale score (mRS) ≤1 before onset:
- The Alberta Stroke Program Early CT score (ASPECTS)≥6 on admission;
- National Institute of Health Stroke Scale (NIHSS) score ≥6 on admission;
- Provision of written informed consent.
Who cannot join
- CT or MRI scan showed significant midline deviation and the mass effect;
- Glasgow(GCS) score ≤8 on admission;
- failure to accomplish 3-months and 6-months follow up;
- Severe cardiac, liver, or kidney disease, malignancy, severe coagulation dysfunction, severe anemia and systemic organ dysfunction;
- Pregnant or nursing women, or patients with moderate to severe mental disorders or dementia;
- Severe soft tissue injuries, fractures, thrombosis and other known peripheral vascular lesions of the upper limbs，active visceral hemorrhage, acute stage of fundus hemorrhage, cerebral aneurysm or cerebral arteriovenous malformation, and other unsuitable for bilateral upper arm compression.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Guogang Luo, doctor, 0086-13991974085, lguogang@163.com
About this study
Official title: Endovascular Treatment Combined With Remote Ischemic Postconditioning in Patients With Acute Ischemic Stroke Improves the Prognosis，a Multicenter, Randomized, Prospective Trial
Endovascular treatment（ET）is an effective therapy for acute ischemic stroke(AIS) with great vessel obstruction. However, acute complications such as high postoperative perfusion injury, hemorrhagic transformation and restenosis resulted in functional independence in only about 50% of patients 90 days after interventional surgery. Therefore, it is very important to protect the neurologic function after emergency endovascular treatment. The investigators' previous studies have shown that combined with intravenous thrombolytic therapy and remote postconditioning（RIPC）can significantly improve the neurological impairment and short-term and long-term prognosis in patients with acute stroke. In this multicenter, randomized controlled trial, the investigators assumed patients with acute ischemic stroke who had successfully revascularization after ET might benefit from RIPC as well. Patients in the RIPC group had five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm after ET. The primary endpoint measure was the proportion of patients with a favorable recovery of nerve function deficient assessed by Modified Rankin Scale （mRS≤2） 90 days after surgery. Secondary endpoints included the following: (1) Symptom endpoints: Neurological intelligence and function scores, postoperative hemorrhagic transformation rate, etc. (2) Blood index test: postoperative inflammatory factors, neuron-specific enolase (NSE) and other indicators. (3) Imaging endpoints: MRI-FLAIR , TCD, etc.
- Conditions
- Acute Ischemic Stroke, Endovascular Treatment
- Being tested
- RIPC device (IPC-906X), foundational treatment
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RIPC device (IPC-906X)Device
Patients in the RIPC group will have five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm twice a day after Mechanical Thrombectomy.
foundational treatmentDrug
foundational treatment, including free radical elimination in the acute stage, blood pressure and blood glucose stabilization, and antiplatelet (aspirin or/and clopidogrel ) and lipid-lowering (statins) drugs
| Study group | Role | What they receive |
|---|---|---|
| RIPC | Experimental | Patients in the RIPC group not only receive foundational treatment but also have five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm using a RIPC device (IPC-906X; Beijing Renqiao Institute of Neuroscience, Beijing, China) after endovascular treatment while in-hospital. Receives: Device: RIPC device (IPC-906X); Drug: foundational treatment |
| foundational treatment group (FT) | Sham comparator | Patients in the FT group only receive foundational treatment, including free radical elimination in the acute stage, blood pressure and blood glucose stabilization, and antiplatelet (aspirin or/and clopidogrel,100-300mg/d) and lipid-lowering (atorvastatin 20-60mg/d,rosuvastatin 10-20mg/d) drugs, during the study period without remote ischemic postconditioning after endovascular treatment. Receives: Drug: foundational treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin scale (mRS)
The percentage of patients with a favorable outcome from baseline at 90 days and 180 days postoperatively, defined as a score of 0 or 2 on the modified Rankin scale (mRS)（Notes:mRS score from 0-6, higher scores mean worse outcome）
Measured: 7days, 90 days and 180 days after the surgery and at discharge
Secondary outcomes (15)
The change of NIHSS score
The percentage of functional recovery from baseline at 90 days and 180 days postoperatively, as measured by the National Institute of Health Stroke Scale, short for NIHSS（Notes:NIHSS score from 0-42. higher scores mean worse outcome）
Measured: 7days, 90 days and 180 days after the surgery and at discharge
The change of Barthel Index
The change of functional recovery from baseline at 90 days and 180 days postoperatively, as measured by the Barthel Index （Notes:Barthel Index score from 0-100. higher scores mean better outcome）
Measured: 7days, 90 days and 180 days after the surgery and at discharge
The change of Montreal Cognitive Assessment (MoCA) score
The change of cognitive recovery from baseline at 90 days and 180 days postoperatively, as measured by the MoCA （Notes:MoCA score from 0-30. higher scores mean better outcome）
Measured: 7days, 90 days and 180 days after the surgery and at discharge
The change of MMSE score
The change of cognitive recovery from baseline at 90 days and 180 days postoperatively, as measured by the MMSE（Notes:MMSE score from 0-30. higher scores mean better outcome）
Measured: 7days, 90 days and 180 days after the surgery and at discharge
The change of inflammatory indicators
Peripheral venous blood was drawn before Endovascular Treatment(ET) and 24 hours and 7 days postoperatively to determine the effect of repeated RIPC on anti-inflammatory (hIL-1β、hIL-2R、hIL-6、hIL8、hIL-10、S100-β、TNF-α) （Notes: unit ng/ml）
Measured: before ET, 24 hours and 7 days after the surgery
The change of angiogenic factors
Peripheral venous blood was drawn before ET and 24 hours and 7 days postoperatively to determine the effect of repeated RIPC on vascular (VEGF、bFGF、EPO、HIF-1α、BDNF) and other pathways (S100B、NSE)（Notes: unit ng/ml）
Measured: before ET, 24 hours and 7 days after the surgery
The change of hemoglobin and Blood viscosity
Peripheral venous blood was drawn before ET and 24 hours and 7 days postoperatively to determine the effect of repeated RIPC on Hb and Blood viscosity（Notes: unit g/L , mPa.s）
Measured: up to 7 days after the surgery
Postoperative hemorrhagic transformation
The proportion of patients with postoperative hemorrhagic transformation, based on CT scan and symptom
Measured: 72 hours after ET and hospitalization
The change of MRI FLAIR Fazekas score
Cerebral white matter demyelination measured by MRI FLAIR Fazekas score，（Notes:Fazekas score from 0-6. higher scores mean worse outcome）
Measured: the changs from within 7 days to 90 days after the surgery
The change of blood flow velocity
Vascular blood flow velocity measured by transcranial doppler （TCD） examination
Measured: the changs from 24 hours after ET to 7 days after the surgery
Vascular resistance
Vascular resistance measured by TCD examination
Measured: the changs from 24 hours after ET to 7 days after the surgery
mortality rate
90-days and 180-days mortality rate
Measured: up to 90 days and 180 days
recurrence rate of cerebrovascular disease
90-days and 180-days recurrence rate of cerebrovascular disease
Measured: up to 90 days and 180 days
blood pressure
The effect of RIPC on blood pressure
Measured: up to 7days
heart rate
The effect of RIPC on heart rate
Measured: up to 7days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2020
- Study start12 Apr 2021
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital of Xi'an Jiaotong University, Shaanxi Provincial People's Hospital, Xijing Hospital, Tang-Du Hospital, Xi'an No.3 Hospital, Xi'an Gaoxin Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04581759
- Sponsor's protocol ID
- XJTU1AF-CRF-2020-015
- Acronym
- EnTRIPS
- Status last verified
- Apr 2022
- First submitted
- 9 Sep 2020
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Cheng Y, Chen W, Chang M, Han X, Yu J, Wei M, Qi Y, Song B, Yao L, Lv H, Jia Y, Zhang X, Zhang G, Qiu Z, Zuo Q, Li G, Zhang Y, Chen C, Ma W, Wang Y, Cheng S, Liu F, Han J, Luo G. Remote Ischemic Postconditioning in Endovascular Thrombectomy for Stroke: The EnTRIPS Randomized Clinical Trial. Stroke. 2026 Aug;57(8):2276-2286. doi: 10.1161/STROKEAHA.126.054857. Epub 2026 Jun 10.
PubMed 42267436
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Treatment Combined With Remote Ischemic Postconditioning in Patients With Acute Ischemic Stroke Improves the Prognosis，a Multicenter, Randomized, Prospective Trial
- ClinicalTrials.gov ID
- NCT04581759
- Acronym / sponsor ID
- EnTRIPS / XJTU1AF-CRF-2020-015
- Conditions
- Acute Ischemic Stroke, Endovascular Treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital of Xi'an Jiaotong University, Shaanxi Provincial People's Hospital, Xijing Hospital, Tang-Du Hospital, Xi'an No.3 Hospital, Xi'an Gaoxin Hospital
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 9 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Endovascular treatment（ET）is an effective therapy for acute ischemic stroke(AIS) with great vessel obstruction. However, acute complications such as high postoperative perfusion injury, hemorrhagic transformation and restenosis resulted in functional independence in only about 50% of patients 90 days after interventional surgery. Therefore, it is very important to protect the neurologic function after emergency endovascular treatment. The investigators' previous studies have shown that combined with intravenous thrombolytic therapy and remote postconditioning（RIPC）can significantly improve the neurological impairment and short-term and long-term prognosis in patients with acute stroke. In this multicenter, randomized controlled trial, the investigators assumed patients with acute ischemic stroke who had successfully revascularization after ET might benefit from RIPC as well. Patients in the RIPC group had five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm after ET. The primary endpoint measure was the proportion of patients with a favorable recovery of nerve function deficient assessed by Modified Rankin Scale （mRS≤2） 90 days after surgery. Secondary endpoints included the following: (1) Symptom endpoints: Neurological intelligence and function scores, postoperative hemorrhagic transformation rate, etc. (2) Blood index test: postoperative inflammatory factors, neuron-specific enolase (NSE) and other indicators. (3) Imaging endpoints: MRI-FLAIR , TCD, etc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RIPC | Experimental | Device: RIPC device (IPC-906X), Drug: foundational treatmentPatients in the RIPC group not only receive foundational treatment but also have five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm using a RIPC device (IPC-906X; Beijing Renqiao Institute of Neuroscience, Beijing, China) after endovascular treatment while in-hospital. |
| foundational treatment group (FT) | Sham comparator | Drug: foundational treatmentPatients in the FT group only receive foundational treatment, including free radical elimination in the acute stage, blood pressure and blood glucose stabilization, and antiplatelet (aspirin or/and clopidogrel,100-300mg/d) and lipid-lowering (atorvastatin 20-60mg/d,rosuvastatin 10-20mg/d) drugs, during the study period without remote ischemic postconditioning after endovascular treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- acute ischemic stroke（AIS） patients with large vessel occlusion (internal carotid artery system and vertebral basilar artery system) within 24 hours after onset, endovascular treatment (mechanical thrombotomy, intra-arterial thrombolysis, balloon dilatation or stent angioplastyand) successful opening were performed, and the definition of successful opening was defined by Modified Thrombolysis standard [Modified Thrombolysis in Cerebral infarction, mTICI]≥ 2B，The standards of endovascular interventional treatment are in line with the indications and contraindications formulated in the Chinese Guidelines for the Early Treatment of Acute Ischemic Stroke 2018；
- Modified Rankin scale score (mRS) ≤1 before onset:
- The Alberta Stroke Program Early CT score (ASPECTS)≥6 on admission;
- National Institute of Health Stroke Scale (NIHSS) score ≥6 on admission;
- Provision of written informed consent.
Key exclusion criteria (6 listed)
- CT or MRI scan showed significant midline deviation and the mass effect;
- Glasgow(GCS) score ≤8 on admission;
- failure to accomplish 3-months and 6-months follow up;
- Severe cardiac, liver, or kidney disease, malignancy, severe coagulation dysfunction, severe anemia and systemic organ dysfunction;
- Pregnant or nursing women, or patients with moderate to severe mental disorders or dementia;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RIPC device (IPC-906X)Patients in the RIPC group will have five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm twice a day after Mechanical Thrombectomy. | Device | RIPC |
| foundational treatmentfoundational treatment, including free radical elimination in the acute stage, blood pressure and blood glucose stabilization, and antiplatelet (aspirin or/and clopidogrel ) and lipid-lowering (statins) drugs | Drug | RIPC, foundational treatment group (FT) |
Primary outcome
Modified Rankin scale (mRS)
Time frame: 7days, 90 days and 180 days after the surgery and at discharge
The percentage of patients with a favorable outcome from baseline at 90 days and 180 days postoperatively, defined as a score of 0 or 2 on the modified Rankin scale (mRS)（Notes:mRS score from 0-6, higher scores mean worse outcome）
15 secondary outcomes
The change of NIHSS score
Time frame: 7days, 90 days and 180 days after the surgery and at discharge
The change of Barthel Index
Time frame: 7days, 90 days and 180 days after the surgery and at discharge
The change of Montreal Cognitive Assessment (MoCA) score
Time frame: 7days, 90 days and 180 days after the surgery and at discharge
The change of MMSE score
Time frame: 7days, 90 days and 180 days after the surgery and at discharge
The change of inflammatory indicators
Time frame: before ET, 24 hours and 7 days after the surgery
The change of angiogenic factors
Time frame: before ET, 24 hours and 7 days after the surgery
The change of hemoglobin and Blood viscosity
Time frame: up to 7 days after the surgery
Postoperative hemorrhagic transformation
Time frame: 72 hours after ET and hospitalization
The change of MRI FLAIR Fazekas score
Time frame: the changs from within 7 days to 90 days after the surgery
The change of blood flow velocity
Time frame: the changs from 24 hours after ET to 7 days after the surgery
Vascular resistance
Time frame: the changs from 24 hours after ET to 7 days after the surgery
mortality rate
Time frame: up to 90 days and 180 days
recurrence rate of cerebrovascular disease
Time frame: up to 90 days and 180 days
blood pressure
Time frame: up to 7days
heart rate
Time frame: up to 7days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2022.
- Derived from this study: PubMed 42267436Cheng Y, Chen W, Chang M, Han X, Yu J, Wei M, Qi Y, Song B, Yao L, Lv H, Jia Y, Zhang X, Zhang G, Qiu Z, Zuo Q, Li G, Zhang Y, Chen C, Ma W, Wang Y, Cheng S, Liu F, Han J, Luo G. Remote Ischemic Postconditioning in Endovascular Thrombectomy for Stroke: The EnTRIPS Randomized Clinical Trial. Stroke. 2026 Aug;57(8):2276-2286. doi: 10.1161/STROKEAHA.126.054857. Epub 2026 Jun 10.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RIPC device (IPC-906X) and foundational treatment in people with Acute Ischemic Stroke and Endovascular Treatment, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guogang Luo, MD (0086-13991974085, lguogang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin scale (mRS) (time frame: 7days, 90 days and 180 days after the surgery and at discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04581759, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.