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A prospective, multicenter, single-group target value clinical trial to evaluate the efficacy and safety of thrombus aspiration catheters in patients with acute ischemic stroke

A prospective, multicenter, single-group target value clinical trial to evaluate the efficacy and safety of thrombus aspiration catheters in patients with acute ischemic stroke

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042459
Enrollment
Unknown
Registered
2021-01-21
Start date
2021-01-21
Completion date
Unknown
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke secondary to intracranial vascular obstruction

Interventions

single arm:thrombus aspiration catheters

Sponsors

Beijing Tiantan Hospital affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Aged >= 18 years, regardless of gender; 2) Acute ischemic stroke was confirmed by DSA to be intracranial internal carotid artery (ICA) or middle cerebral motility Occlusion of artery (MCA) M1 / M2 or anterior cerebral artery (ACA) A1 / A2; 3) mRS score 0 ~ 1 before onset; 4) Preoperative NIHSS score >= 6; 5) CT or MRI based ASPECT score >= 6; 6) The time from onset to puncture shall be within 6 hours; 7) The patient or legal guardian signs the informed consent.

Exclusion criteria

Exclusion criteria: 1) CT or MRI suggested intracranial hemorrhage (SWI microhemorrhage was not considered); 2) CT or MRI indicated large cerebral infarction (ASPECT score MCA)1/3 of the blood supply area or the infarcted volume was > 70ml); 3) DSA suggested vascular occlusion of bilateral carotid artery system; 4) DSA suggested tortuous vascular path, and the instrument was difficult to reach the target vessel; 5) The target vessel is known to be chronic occlusion; 6) Those who are known to be severely allergic to contrast agents (excluding rashes); 7) refractory hypertension beyond drug control, defined as systolic bp > 185mmHg or diastolic bp > 110 MMHG. 8) Baseline blood glucose 3 Or platelet count < 40 x 10^9/L; 10) There is known to be severe heart, lung, liver and kidney failure or other serious disease (such as an untreated intracranial swelling, aneurysms, intracranial aneurysms or arteriovenous malformations); 11) Patients with mental illness; 12) A history of major surgery 30 days before enrollment; 13) Life expectancy < 90 days; 14) Pregnant or lactating women; 15) Is participating in any other drug or medical device clinical trial, or may be after being enrolled in this clinical trial To participate in clinical trials of any other drug or medical device; 16) The researcher judged that there were other conditions that were not suitable for the group.

Design outcomes

Primary

MeasureTime frame
The success rate of target vessel confirmed by DSA immediately after surgery (mTICI 2B-3).;

Countries

China

Contacts

Public ContactNing Ma

Beijing Tiantan Hospital affiliated to Capital Medical University

maning03@hotmail.com+86 13581889908

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026