Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-27 @ 8:41 PM
Study NCT ID:
NCT04581759
Status:
UNKNOWN
Last Update Posted:
2022-05-10
First Post:
2020-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endovascular Treatment and RIPC in Acute Ischemic Stroke
Sponsor:
First Affiliated Hospital Xi'an Jiaotong University
Organization:
Study Overview
Official Title:
Endovascular Treatment Combined With Remote Ischemic Postconditioning in Patients With Acute Ischemic Stroke Improves the Prognosis，a Multicenter, Randomized, Prospective Trial
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EnTRIPS
Brief 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 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: