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Prospective, Multicenter, Single-Arm Clinical Trial to Evaluate the Efficacy and Safety of the Sailwire Guiding Sheath in Percutaneous Vascular Interventions

Prospective, Multicenter, Single-Arm Clinical Trial to Evaluate the Efficacy and Safety of the Sailwire Guiding Sheath in Percutaneous Vascular Interventions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103504
Enrollment
Unknown
Registered
2025-05-30
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

Diseases requiring percutaneous vascular interventions

Interventions

Experimental group:The Sailwire guiding sheath is used to establish vascular access and deliver interventional devices during the procedure.

Sponsors

The Fifth Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Age >= 18 years, with no gender restriction; 2.Requires percutaneous vascular intervention; 3.The investigator determines that the guide sheath is necessary during the procedure; 4.Signed informed consent form.

Exclusion criteria

Exclusion criteria: 1.Known severe allergy or contraindication to contrast agents, anesthetic drugs, or any component of the investigational device; 2.Pregnant or lactating women; 3.Currently participating in clinical trials of drugs or other medical devices; 4.Severe vascular tortuosity unsuitable for interventional treatment; 5.Deemed unsuitable for enrollment in this clinical trial by the investigator.

Design outcomes

Primary

MeasureTime frame
Device success rate;

Secondary

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

Countries

China

Contacts

Public ContactWang Bing

The Fifth Affiliated Hospital of Zhengzhou University

hnxgwk@126.com+86 137 0371 3788

Outcome results

None listed

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