Ignite Creation Date:
2024-05-06 @ 7:29 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06024525
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-06
First Post:
2023-08-15
Brief Title:
Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters Swide
Sponsor:
Shanghai Shenqi Medical Technology Co Ltd
Organization:
Shanghai Shenqi Medical Technology Co Ltd
Study Overview
Official Title:
Prospective Multi-center Non-inferiority and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Paclitaxel-Coated Coronary Balloon Catheters Swide
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
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 objective of this study is to assess the safety and efficacy of the Paclitaxel-Coated Coronary Balloon Catheters Swide 3µgmm2 balloon surface area in the treatment of Chinese patients with native coronary heart disease and small vessel lesionsreference diameters from 20mm to 275 mm in comparison with Paclitaxel-Releasing Coronary Balloon Catheter SeQuent please Neo
Detailed Description:
This study conducted a prospective multi-center randomized controlled non-inferiority clinical trial to compare the safety and efficacy of the Shenqi Medical paclitaxel-coated coronary balloon catheter and the paclitaxel-eluting coronary balloon catheter SeQuent please Neo in the treatment of coronary artery small vascular disease
A total of 236 participants are planned to be recruited and they will be allocated into the experimental group and the control group in a 11 ratio
All participants will undergo clinical follow-up at 1 month 6 months 9 months 1 year and 2 years after receiving the drug-eluting balloon angioplasty procedure
Angiographic re-evaluation will be conducted for all participants at 9 months after the procedure The primary study endpoint will be the in-segment diameter stenosis in target lesion at 9 months postoperatively
A total of 236 participants are planned to be recruited and they will be allocated into the experimental group and the control group in a 11 ratio
All participants will undergo clinical follow-up at 1 month 6 months 9 months 1 year and 2 years after receiving the drug-eluting balloon angioplasty procedure
Angiographic re-evaluation will be conducted for all participants at 9 months after the procedure The primary study endpoint will be the in-segment diameter stenosis in target lesion at 9 months postoperatively
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