Evaluation of Clinical Effectiveness and Safety of Locaste 8F Guiding Catheter in Neurovascular Interventional Surgery

NCT06917248 | Completed

• 1 other identifier: CIP-PICA-RWD
• Study Type: observational
• Target: 113
• Locations: 1 country
• Sites: 2

Brief Summary

The Locaste 8F Delivery Catheter by Kai MedTech has been launched in China since 2022 and has been widely used clinically. It won the government tendering in many provinces in China in early 2024. As a guiding and access device, the investigational device is used in interventional surgeries. The clinical investigation plans to conduct a non-interventional post-marketing real-world study to evaluate the safety and effectiveness of the product in clinical use. The investigator shall use the Locaste 8F Guiding Catheter according to his own surgery plan and the instruction for use (IFU) of this device. The large-bore guiding catheters (also called as long guiding sheath) by global manufacturers are generally used. Locaste 8F Guiding Catheter is marketed in China and widely accepted in clinical application. By collecting data in the real-world clinical routine treatment, the effectiveness and the safety of Locaste 8F Guiding Catheter is evaluated to provide data support of further global use of this device.

Conditions

Stroke; Hemorrhagic Strokes

Keywords

Locaste; Long sheath; Guiding catheter

Outcome Measures

Primary Outcomes (1)

• Device Success Rate

  Definition：Number of Patients with Device Success / Number of Recruited Patients \* 100% Device Success： Use 5-Point Likert Scale to evaluate the navigability of device to the targeted vessel position. 1. Unsatisfactory； 2. Unacceptable； 3. Adequate； 4. Good; 5. Excellent； Device success is defined as the score ≥3.

  Day 0 （During surgery）

Secondary Outcomes (5)

• Ability to deliver other interventional devices

  Day 0（During surgery）

• Visibility under X-ray

  Day 0（During surgery）

• Ability to support other interventional devices

  Day 0（During surgery）

• Device Deficiency

  Day 0 (During surgery)

• Adverse Event (AE)

  Day 0(during surgery) or Day 1 (within 24 hours after the surgery)

Study Arms (1)

Locaste 8F Guiding Catheter in Neurovascular interventional surgery

Patients with Locaste 8F Guiding Catheter used in the neurovascular interventional surgery and the surgery video of the Locaste 8F Guiding Catheter available are recruited in this study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undertaken a neurovascular intervention surgery procedure including Locaste 8F Guiding Catheter in a reverse chronological order earlier than the date of the ethic approval.

You may qualify if:

• Age of 18 years or older;
• Undertaken a neurovascular surgery procedure including Locaste 8F Guiding Catheter;
• Available images of Locaste 8F Guiding Catheter in the neurovascular surgery;

You may not qualify if:

• Disorders of vascular fragility (e.g. Ehlers-Danlos syndrome)
• Prior vascular dissection or injury to vessels to be catheterized

Sponsors & Collaborators

• Keuro MedTech: lead

Study Sites (2)

Xinxiang City Central Hospital

Xinxiang, Henan, 453000, China

Location

Zhumadian City Central Hospital

Zhumadian, Henan, 463000, China

Location

MeSH Terms

Conditions

Stroke; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: April 8, 2025
• Study Start: May 21, 2024
• Primary Completion: October 7, 2024
• Study Completion: October 7, 2024
• Last Updated: June 24, 2025

Record last verified: 2025-06

Locations

CN (2)