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A prospective, multicenter, randomized controlled clinical trial of the safety and efficacy of cold laser plaque ablation for coronary artery disease

A prospective, multicenter, randomized controlled clinical trial of the safety and efficacy of cold laser plaque ablation for coronary artery disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400093483
Enrollment
Unknown
Registered
2024-12-05
Start date
2024-12-10
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Coronary artery disease

Interventions

Experimental group:Cold laser plaque ablation
Control group:Excimer laser ablation

Sponsors

Zhongshan Hospital affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: General Inclusion Criteria: 1. 18 years old=2mm; 2. Only one target lesion was enrolled; 3. The guidewire passes through the true lumen of the target lesion.

Exclusion criteria

Exclusion criteria: 1. The laser catheter cannot reach the proximal end of the target lesion; 2. Severe angular lesions; 3. Unprotected left main lesions; 4. The target lesion has severe flow-limiting dissection; 5. New York Heart Association (NYHA) cardiac function grade III or IV; 6. Participated in other clinical trials in the past 1 month; 7. Other conditions that are considered by the investigator to be unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Procedural success;—

Secondary

MeasureTime frame
Technical success;Clinical success;Performance; AE/SAE;Device deficiencies;Major cardiac adverse events;—

Countries

China

Contacts

Public ContactJunbo Ge

Zhongshan Hospital affiliated to Fudan University

ge.junbo@zs-hospital.sh.cn+86 21 6404 1990

Outcome results

None listed

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