Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:46 PM
Study NCT ID:
NCT05606367
Status:
UNKNOWN
Last Update Posted:
2023-04-07
First Post:
2022-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Coronary Non-slip Balloon Catheter in Patients With Coronary Artery Stenosis(CREST)
Sponsor:
Shanghai MicroPort Rhythm MedTech Co., Ltd.
Organization:
Study Overview
Official Title:
A Prospective, Randomized, Multicenter Clinical Trial of Non-slip Balloon Catheter in Patients With Coronary Artery Stenosis
Status:
UNKNOWN
Status Verified Date:
2023-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective, multicenter, randomized controlled clinical investigation aiming to evaluate the safety and effectiveness of non-slip balloon catheter for the treatment of patients with coronary artery stenosis.
Detailed Description:
This trial is a prospective, multicenter, randomized controlled clinical trial. 200 subjects are expected to be recruited in 7 research centers in China and randomly divided into two groups according to the ratio of test group: control group = 1:1. The primary endpoint is the acute lumen gain.
All subjects receive clinical follow-up during hospitalization and 30 days after surgery.
All subjects receive clinical follow-up during hospitalization and 30 days after surgery.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: