Ignite Creation Date:
2024-10-25 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527963
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
DRug-coAted Balloon Compared With cuttinG balloON in Treatment of Arteriovenous Fistula Stenosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
DRug-coAted Balloon Compared With cuttinG balloON in Treatment of Arteriovenous Fistula Stenosis
Status:
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:
Dragon
Brief Summary:
The purpose of this clinical trial is to compare the efficacy and safety of cutting balloons versus drug-coated balloons in treating venous stenosis of autologous arteriovenous fistulasThe main questions it aims to answer are
1 Will drug-coated balloons achieve a better CD-TLR rate compared to cutting balloons
2 What medical problems do participants have when receiving treatment with drug-coated balloons or cutting balloons
1 Will drug-coated balloons achieve a better CD-TLR rate compared to cutting balloons
2 What medical problems do participants have when receiving treatment with drug-coated balloons or cutting balloons
Detailed Description:
The study will recruit 180 patients with venous segment stenosis of autologous arteriovenous fistulas at multiple centers from June 2024 to December 2025 Patients will be divided into two cohorts based on the treatment method the Cutting Balloon group and the Drug-Coated Balloon group The primary outcomes observed will be the primary patency rates of the target lesion at 1 3 6 and 12 months post-operation re-intervention rates of the target vessel and the technical success rates and procedural success rates of the two devices along with major adverse events during the perioperative period
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