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

NCT03716011 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2700

Last updated 2018-10-23

No results posted yet for this study

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;

Conditions

Interventions

DEVICE

EXCROSSAL

a Second Generation Biodegradable Polymer Sirolimus-Eluting Stent

Sponsors & Collaborators

  • JW Medical Systems Ltd

    lead INDUSTRY

Principal Investigators

  • Hao M Lu, Ph.D · Zhongshan hospital of ShangHai FuDan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-20
Primary Completion
2021-12-20
Completion
2025-12-20

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03716011 on ClinicalTrials.gov