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.

Hemodialysis Access Failure Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04285073
• Other study ID #: SMC 2018-03-017
• Status: Recruiting
• Phase: N/A
• Start date: November 13, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2020
• Source: Samsung Medical Center
• Contact: DaeJoong Kim
• Phone: 82234103441
• Email: daejoongsmc.kim[@]samsung.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

1. Evaluation of safety Primary outcome: all adverse events occurring in the subject

2. Evaluation of effectiveness Primary outcome: AV graft primary patency Secondary outcome:

AV graft secondary patency

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis Access Failure
• Kidney Failure, Chronic

Intervention

Device:
• Paclitaxel-eluting graft
Implantation of e-PTFE Grafts inner surface-treated with paclitaxel as access for hemodialysis

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	All adverse events occurring in the subject	Up to 2 years after implantation of AVG
Primary	Primary patency	Percentage of no intervention (intravascular or surgical) to maintain or recover blood flow or occurrence to access thrombosis	at 6 months after implantation of AVG
Secondary	Secondary patency	Percentage of no permanent failure of AVG	Up to 2 years after implantation of AVG