NCT03716011

A Postmarket Clinical Trial for EXCROSSAL Stent in CAD Patients With 3-month DAPT or 12-month DAPT

A Large, Prospective, Randomized, Multicenter Clinical Study Evaluating the Safety and Efficacy of the Post-marketing Drug-eluting Stent System (Rapamycin) - the EXCROSSAL Stent in CAD Patients With 3-month DAPT or 12-month DAPT

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,700 (estimated)
• Sponsor: JW Medical Systems Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

1. Prospective, randomized, multicenter clinical study 2. This is a post-marketing clinical study to evaluate whether it will affect the safety event when it is used in different treatment ways. Adopting non - inferiority design, 2700 cases were enrolled. 3. EDC system (eCRF electronic data collection system) 4. Follow-up points: 30 days,3 months, 12 months, 24 months, 36 months, 48 months and 60 months after the operation;

Detailed description

1. Subjects are eligible for coronary intervention 2. The lesion needs to be pre-expanded or special circumstances should be carefully considered according to the clinical manifestations 3. The selection of target vessel is based on the criteria of a diameter between 2.25mm and 4.0mm 4. If a stent needs to be placed at the target vessel, it is recommended that there be at least 2mm overlap between the stents; if the stent expansion is not sufficient, post-dilatation treatment is required.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	EXCROSSAL	a Second Generation Biodegradable Polymer Sirolimus-Eluting Stent

Timeline

• Start date: 2018-12-20
• Primary completion: 2021-12-20
• Completion: 2025-12-20
• First posted: 2018-10-23
• Last updated: 2018-10-23

Locations

1 site across 1 country: China