Skip to content

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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125079
Enrollment
Unknown
Registered
2026-05-21
Start date
2026-06-01
Completion date
Unknown
Last updated
2026-05-25

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

Conditions

Adult patients scheduled for neurovascular interventional procedures

Interventions

single-arm group:The interventional device reaches the target vessel and establishes a pathway

Sponsors

Henan Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Age >=18 and <=85; 2. Proposed neurovascular interventional surgery; 3. Signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Documented severe allergy or contraindication to contrast media, anesthetic agents, or any component of the investigational device; 2. Intraoperatively, the access vessel was difficult to puncture or too tortuous for the guidewire to pass, precluding interventional therapy; 3. Subarachnoid hemorrhage or intracranial hemorrhage within 2 months; 4. The target aneurysm is blood bubble-like aneurysm, , infectious aneurysm or ruptured aneurysm; 5. Pregnant or lactating females; 6. Participating in other clinical investigations; 7. Not eligible for this investigation as judged by the investigator.

Design outcomes

Primary

MeasureTime frame
Device success rate;

Secondary

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

Countries

China

Contacts

Public ContactWang Ziliang

Henan Provincial People's Hospital

wzl731023@163.com+86 731 5684 1086

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 30, 2026