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A prospective, single-center, observational clinical study based on optical coherence tomography (OCT) to evaluate the preconditioning effect of the ScoreFlex TRIO high-voltage three-wire notched balloon catheter for coronary artery stenosis

A prospective, single-center, observational clinical study based on optical coherence tomography (OCT) to evaluate the preconditioning effect of the ScoreFlex TRIO high-voltage three-wire notched balloon catheter for coronary artery stenosis

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300072449
Enrollment
Unknown
Registered
2023-06-14
Start date
2023-06-15
Completion date
Unknown
Last updated
2023-06-18

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

Conditions

coronary artery stenosis

Interventions

Case series:Coronary OCT examination is performed prior to the use of the ScoreFlex TRIO or ScoreFlex NC to assist in the assessment of coronary target lesions. On the basis of coronary OCT examinatio

Sponsors

Zhongshan Hospital Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily participate in the study and sign the informed consent; 2. Participants who participated in the ScoreFlex TRIO premarket clinical trial and were randomly enrolled.

Exclusion criteria

Exclusion criteria: 1. Subjects who meet any of the ScoreFlex TRIO exclusion criteria in premarket clinical trials; 2. Subjects with contraindications of coronary OCT examination; 3. Other cases assessed by the investigators as unsuitable for coronary OCT examination.

Design outcomes

Primary

MeasureTime frame
Minimum lumen diameter (MLD) improved;Improvement of minimum lumen diameter stenosis (MLDS);Improvement of minimum lumen area (MLA);Plaque assessment;Expansion rate of support;Bracket wall adhesion defect rate;Incidence of tissue prolapse;Incidence of stent edge dissection;Incidence of stent thrombosis;

Countries

China

Contacts

Public ContactJunbo Ge

Zhongshan Hospital Affiliated to Fudan University

ge.junbo@zs-hospital.sh.cn+86 198 2273 9022

Outcome results

None listed

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