Ignite Creation Date:
2024-05-06 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 2:31 PM
Study NCT ID:
NCT05342961
Status:
UNKNOWN
Last Update Posted:
2022-04-25
First Post:
2022-03-15
Brief Title:
Safety and Efficacy of Spinous Balloon Dilatation Catheter in CAD Treatment
Sponsor:
CCRF Inc Beijing China
Organization:
CCRF Inc Beijing China
Study Overview
Official Title:
A Prospective Multicenter Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of Spinous Balloon Dilatation Catheter Plastic-BladeTM in the Treatment of Coronary Artery Disease
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
NOT_YET_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:
The purpose of this study is to evaluate the safety and effectiveness of spinous process balloon dilation catheter Plastic-Blade in coronary vascular diseases which is not inferior to the similar product on the market - coronary spinous process balloon dilation catheter lacrosse NSE produced by Goodman Co Ltd
Detailed Description:
This study is a prospective multicenter randomized controlled and non inferiority designed clinical trial A total of 160 subjects with CAD from 8 centers will be randomized 11 to each group All subjects evaluated the immediate lumen acquisition immediately after operation and the MACE of 30 7 days after operation The primary endpoint is the acquisition of lumen immediately after operation The effectiveness of balloon was evaluated The safety of balloon was evaluated by adverse events during operationClinical follow-up will be conducted at operation discharge and 30 7 days after operation The target lesions included the following opening lesions bifurcation lesions calcification lesions and fibrosis lesions Diameter stenosis 70 visual with evidence of ischemia Localized lesions with TIMI 1 RVD200 and 400mm and the vascular segment is suitable for balloon dilatation in anatomical structure
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?:
None