Hemodialysis Access FailureNCT04285073
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.
A study testing Paclitaxel-eluting graft in people with Hemodialysis Access Failure, run by Samsung Medical Center at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hemodialysis Access Failure
- What is being tested?
- Paclitaxel-eluting graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Nov 2018to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Dae Joong Kim contact
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
Dae Joon g Kim
Dae Joong Kim
About this study
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.
Read the 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
- Conditions
- Hemodialysis Access Failure
- Being tested
- Paclitaxel-eluting graft
- Keywords
- hemodialysis, vascular access, arteriovenous graft, paclitaxel-eluting graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel-eluting graftDevice
Implantation of e-PTFE Grafts inner surface-treated with paclitaxel as access for hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel-eluting graft | Experimental | Single-arm Receives: Device: Paclitaxel-eluting graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
All adverse events occurring in the subject
Measured: Up to 2 years after implantation of AVG
Primary patency
Percentage of no intervention (intravascular or surgical) to maintain or recover blood flow or occurrence to access thrombosis
Measured: at 6 months after implantation of AVG
Secondary outcomes (1)
Secondary patency
Percentage of no permanent failure of AVG
Measured: Up to 2 years after implantation of AVG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start13 Nov 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodialysis Access FailureStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Dae Joong, Samsung Medical Center
- Investigators
- Dae Joong Kim, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04285073
- Sponsor's protocol ID
- SMC 2018-03-017
- Status last verified
- Feb 2020
- First submitted
- 24 Feb 2020
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04285073
- Acronym / sponsor ID
- SMC 2018-03-017
- Conditions
- Hemodialysis Access Failure
- Keywords
- hemodialysis, vascular access, arteriovenous graft, paclitaxel-eluting graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel-eluting graft | Experimental | Device: Paclitaxel-eluting graftSingle-arm |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel-eluting graftImplantation of e-PTFE Grafts inner surface-treated with paclitaxel as access for hemodialysis | Device | Paclitaxel-eluting graft |
Primary outcome
Adverse events
Time frame: Up to 2 years after implantation of AVG
All adverse events occurring in the subject
Primary patency
Time frame: at 6 months after implantation of AVG
Percentage of no intervention (intravascular or surgical) to maintain or recover blood flow or occurrence to access thrombosis
1 secondary outcome
Secondary patency
Time frame: Up to 2 years after implantation of AVG
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dae Joong Kim contact
Dae Joong Kim principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel-eluting graft in people with Hemodialysis Access Failure, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact DaeJoong Kim (82234103441, daejoongsmc.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: Up to 2 years after implantation of AVG). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.