NCT05552911

Drug-coated Balloon Therapy for In-stent Restenosis and de Novo Coronary Lesions

Clinical Prognosis and Influencing Factors of Drug-coated Balloon Therapy in Patients With Coronary In-stent Restenosis and de Novo Coronary Lesions

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a single-center, prospective, open-label, observational study. Patients with coronary artery disease confirmed by coronary angiography and treated with drug-coated balloon catheter alone for target vessels were enrolled in the Cardiology Department of our hospital in January 2022. The primary endpoint was late lumen loss within 12±3 months after surgery.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
PROCEDURE	Pretreatment strategies before drug balloon therapy	Preconditioning strategies for the treatment of in de novo coronary lesions using drug-coated balloons.
PROCEDURE	Different types of in-stent restenosis were treated with drug-coated balloons	A new classification method of ISR lesions was proposed to observe the clinical prognosis of different ISR lesions treated with drug-coated balloon.

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-12-30
• Completion: 2023-12-30
• First posted: 2022-09-23
• Last updated: 2022-10-26

Locations

1 site across 1 country: China