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.

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    Samsung Medical Center
Updated on 19 February 2024

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

Details
Condition Hemodialysis Access Failure
Age 20years - 80years
Treatment Paclitaxel-eluting graft
Clinical Study IdentifierNCT04285073
SponsorSamsung Medical Center
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study AnnotationsStudy Notes

Notes added here are public and can be viewed by anyone. Notes added here are only available to you and those who you share with.

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.