Back to resultsProspective, Multicenter, Non-randomized, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of e-PTFE Grafts Inner Surface-treated With Paclitaxel as an Access for Hemodialysis in Patients With End-stage Renal Disease.
Primary Purpose
Hemodialysis Access Failure
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Paclitaxel-eluting graft
Sponsored by
About this trial
This is an interventional other trial for Hemodialysis Access Failure focused on measuring hemodialysis, vascular access, arteriovenous graft, paclitaxel-eluting graft
Eligibility Criteria
Inclusion Criteria:
- Adult male or female between the ages of 20 and 80
- Patients currently undergoing or scheduled for hemodialysis due to end-stage kidney disease.
- Patients who decided to receive AVG procedure in forearm due to inability to perform autologous arteriovenous fistula (AVF)
- Patients with a high risk of stenosis (neointimal hyperplasia) or thrombosis when artificial blood vessels were implanted
Exclusion Criteria:
- Pregnant or lactating women
- Patients who are currently diagnosed with malignant tumors and are receiving chemotherapy or radiotherapy
- Patients with life expectancy less than 12 months
- Patients expected to receive a kidney transplant during the trial
- Patients with current or suspected infection
- Acute psychiatric problems require treatment
- Patients who have inserted a catheter into an artery or vein in their upper limb for AVG procedure within the last 30 days
- Patients with coagulation disorder, platelet count <50,000 / Ul
- Patients with a neutrophil count of less than 1,500 cells / mm3
- Patients judged to be unable to insert grafts by the operator
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Paclitaxel-eluting graft
Arm Description
Single-arm
Outcomes
Primary Outcome Measures
Adverse events
All adverse events occurring in the subject
Primary patency
Percentage of no intervention (intravascular or surgical) to maintain or recover blood flow or occurrence to access thrombosis
Secondary Outcome Measures
Secondary patency
Percentage of no permanent failure of AVG
Full Information
NCT ID
NCT04285073
First Posted
February 24, 2020
Last Updated
February 24, 2020
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04285073
Brief Title
Prospective, Multicenter, Non-randomized, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of e-PTFE Grafts Inner Surface-treated With Paclitaxel as an Access for Hemodialysis in Patients With End-stage Renal Disease.
Official Title
Prospective, Multicenter, Non-randomized, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of e-PTFE Grafts Inner Surface-treated With Paclitaxel as an Access for Hemodialysis in Patients With End-stage Renal Disease.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Recruiting
Study Start Date
November 13, 2018 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This prospective, multicenter, non-randomized, single-arm Clinical trial aims to evaluate the safety and effectiveness of the use of paclitaxel-coated arteriovenous graft (AVG) on the inner wall of ePTFE graft, which is designed to reduce neointimal hyperplasia that causes stenosis and thrombosis after implantation of AVG.
Detailed Description
Evaluation of safety Primary outcome: all adverse events occurring in the subject
Evaluation of effectiveness Primary outcome: AV graft primary patency Secondary outcome: AV graft secondary patency
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis Access Failure
Keywords
hemodialysis, vascular access, arteriovenous graft, paclitaxel-eluting graft
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Paclitaxel-eluting graft
Arm Type
Experimental
Arm Description
Single-arm
Intervention Type
Device
Intervention Name(s)
Paclitaxel-eluting graft
Intervention Description
Implantation of e-PTFE Grafts inner surface-treated with paclitaxel as access for hemodialysis
Primary Outcome Measure Information:
Title
Adverse events
Description
All adverse events occurring in the subject
Time Frame
Up to 2 years after implantation of AVG
Title
Primary patency
Description
Percentage of no intervention (intravascular or surgical) to maintain or recover blood flow or occurrence to access thrombosis
Time Frame
at 6 months after implantation of AVG
Secondary Outcome Measure Information:
Title
Secondary patency
Description
Percentage of no permanent failure of AVG
Time Frame
Up to 2 years after implantation of AVG
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult male or female between the ages of 20 and 80
Patients currently undergoing or scheduled for hemodialysis due to end-stage kidney disease.
Patients who decided to receive AVG procedure in forearm due to inability to perform autologous arteriovenous fistula (AVF)
Patients with a high risk of stenosis (neointimal hyperplasia) or thrombosis when artificial blood vessels were implanted
Exclusion Criteria:
Pregnant or lactating women
Patients who are currently diagnosed with malignant tumors and are receiving chemotherapy or radiotherapy
Patients with life expectancy less than 12 months
Patients expected to receive a kidney transplant during the trial
Patients with current or suspected infection
Acute psychiatric problems require treatment
Patients who have inserted a catheter into an artery or vein in their upper limb for AVG procedure within the last 30 days
Patients with coagulation disorder, platelet count <50,000 / Ul
Patients with a neutrophil count of less than 1,500 cells / mm3
Patients judged to be unable to insert grafts by the operator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DaeJoong Kim
Phone
82234103441
Email
daejoongsmc.kim@samsung.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dae Joong Kim
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Joong Kim
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dae Joon g Kim
First Name & Middle Initial & Last Name & Degree
Dae Joong Kim
12. IPD Sharing Statement
Learn more about this trial
Prospective, Multicenter, Non-randomized, Single Arm Clinical Trial to Evaluate the Safety and Efficacy of e-PTFE Grafts Inner Surface-treated With Paclitaxel as an Access for Hemodialysis in Patients With End-stage Renal Disease.
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