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A prospective, multi-center, single-group target value clinical investigation to evaluate the efficacy and safety of Willskey Microcatheter in the neurovascular interventional procedure

A prospective, multi-center, single-group target value clinical investigation to evaluate the efficacy and safety of Willskey Microcatheter in the neurovascular interventional procedure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085345
Enrollment
Unknown
Registered
2024-06-05
Start date
2024-06-10
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Patients proposed to undergo the neurovascular interventional procedure.

Interventions

single-arm group:Selective delivery of control medium, embolic material and/or medical devices to the target vessel by the investigational device

Sponsors

Nanyang Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.18 to 85 years old; 2. Proposed for the neurovascular interventional procedure; 3.Signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Experiencing surgery or interventional therapy within 1 month; 2.Subarachnoid hemorrhage or intracranial hemorrhage within 2 months; 3.Active ulcer has occurred within 6 months; 4.Preoperative blood pressure> 180 / 100 mmHg or <90 / 60 mmHg; 5.The target aneurysm is blood bubble-like aneurysm, dissecting aneurysm, infectious aneurysm or ruptured aneurysm; 6.The intraoperative microguidewire cannot pass through the target vessel; 7.Pregnant or lactating females; 8.Participating in other clinical investigations; 9.Other operational contraindications (such as severe allergy to anticoagulant / antiplatelet drugs, anesthetic drugs, contrast agents or existing contraindications; acute myocardial infarction, etc.); 10.Not eligible for this investigation as judged by the investigator.

Design outcomes

Primary

MeasureTime frame
Device success rate;

Secondary

MeasureTime frame
Procedural success rate;Incidence of adverse events;Incidence of serious adverse events;Incidence of device defects;

Countries

China

Contacts

Public ContactWen Chang Ming

Nanyang Central Hospital

13838729696@sina.com+86 731 5684 1086

Outcome results

None listed

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