Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06503692
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Scoring Balloon and High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multicentre Randomized Controlled Clinical Trial of Scoring Balloon Versus High Pressure Balloon in the Treatment of Arteriovenous Graft Stenosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DKTAVG
Brief Summary:
This is a multicenter prospective randomized controlled clinical study Patients with hemodialysis arteriovenous graft fistula stenosis will be recruited to explore whether the scoring balloon is superior to the high pressure balloon in treating such lesions so as to provide a basis for optimizing the treatment of such lesions
This study will be conducted in seven 7 clinical trial institutions with a total of 140 subjects included After randomization the subjects will use either the scoring balloon dilatation catheter developed and produced by DK Medical Technology Co Ltd or the peripheral balloon dilatation catheter for surgical treatment Clinical follow-up will be carried out within 5 days 3 months 6 months and 12 months after the procedure
This study will be conducted in seven 7 clinical trial institutions with a total of 140 subjects included After randomization the subjects will use either the scoring balloon dilatation catheter developed and produced by DK Medical Technology Co Ltd or the peripheral balloon dilatation catheter for surgical treatment Clinical follow-up will be carried out within 5 days 3 months 6 months and 12 months after the procedure
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None