Hemodialysis Access FailureNCT06454396
Effectiveness and Health Economics of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure
An observational study of Hemodialysis Access Failure, run by RenJi Hospital at 1 site in China.
Trial summary
This study was aimed at evaluating the efficacy of different endovascular treatments for early and mid-stage clinical interventions in patients with autologous arteriovenous fistulae loss of function and the corresponding health economic value. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemodialysis Access Failure
- What is being tested?
- Endovascular therapy
- Type of treatment
- Surgery or procedure
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Dysfunctional autogenous arteriovenous fistula patient: A stenosis in a hemodialysis access with significant hemodynamic changes: Based on angiography/ultrasound evaluation, the target lesion stenosis is ≥50%, and is accompanied by one or more of the following clinical and physiological abnormalities: natural fistula blood flow <480ml/min; unable to meet the required blood flow for the dialysis prescription; thrombosis in the autogenous arteriovenous fistula; elevated venous pressure during dialysis; difficult cannulation; decreased dialysis adequacy; and abnormal signs in the fistula, etc.
Who may be able to join
- Hemodialysis patients over 18 years of age and under 80 years of age
- Autologous arteriovenous fistula cannot be used in patients completing haemodialysis
- The guidewire must pass through at least the stenosis of the endovascular fistula on the side of the lesion and undergo further endovascular treatment before enrolment, and this study does not limit the form of the guidewire passing through the target lesion.
- Patients who have failed to open the initial target lesion and are successful on a second attempt at endoluminal therapy may still be enrolled.
- Subjects and their legal representatives are able to understand the purpose of the study, participate voluntarily and sign an informed consent form, and are willing to be followed up at specific points in time.
Who cannot join
- Planned kidney transplant or conversion to peritoneal dialysis
- Women who are pregnant, breastfeeding or planning to become pregnant during the study period
- Recent (within 30 days) or planned surgical procedure for haemodialysis access
- Allergy or contraindication to heparin, contrast media, antiplatelet drugs
- Patients who have participated in a clinical trial of a drug or other medical device that interferes with this clinical trial within the last 3 months.
- Patients with a history of coagulation disorders or other haematological disorders
- Patients with other conditions that may make the trial difficult or significantly shorten the patient's life expectancy (<2 years), e.g. tumours, severe liver disease, cardiac insufficiency, etc., or patients with a life expectancy of less than 6 months.
- Patients unable or unwilling to participate in this trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Renji Hospital
Shanghai, Shanghai Municipality
Jingpu Zhu, +86-17520505530
Lan Zhang, M.D.
About this study
Official title: A Real-world Clinical Study Based on a Decentralized Arteriovenous Endovascular Fistula Data System - Effectiveness and Health Economics of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure
This study was aimed at evaluating the efficacy of different endovascular treatments for early and mid-stage clinical interventions in patients with autologous arteriovenous fistulae loss of function and the corresponding health economic value.
Read the detailed description
This is a prospective, single-center, real-world study intended to understand the clinical intervention efficacy and health economic value of various real-world endovascular treatments for autologous arteriovenous endovascular fistulae failure in a target lesion defined as the hemodialysis access inflow tract (arterial, anastomotic, and inflection), intermediate segment, and outflow tract vein. The study will enroll 480 patients with autologous arteriovenous endovascular fistulae that have failed during the period 2023/1-2024/12, in a single center. They will be divided into subgroups according to different treatment modalities, such as balloon dilatation alone group, medicated balloon group, and stent implantation group. The main observations were the technical success rate of various endoluminal treatment methods, perioperative major adverse events, and symptom-driven target lesion re-intervention rate, target vessel patency rate, and total hospitalization expenditures related to the target lesion at 1, 6, 12, 18, and 24 months after the procedure.
- Conditions
- Hemodialysis Access Failure
- Being tested
- Endovascular therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endovascular therapyProcedure or surgery
Endovascular therapy is a minimally invasive interventional approach that utilizes the vascular system as a pathway to access and treat various pathological conditions within the body. By employing specialized catheters and devices, endovascular techniques enable precise delivery of therapeutic agents or interventional procedures directly to the target site, without the need for conventional open surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically-driven target lesion re-intervention
Clinically-driven target lesion re-intervention refers to a repeat procedure performed on a previously treated lesion due to the recurrence of symptoms or other clinical indications, rather than being routinely scheduled.
Measured: 1-month；6-month；12-month；18-month；24-month
Secondary outcomes (2)
target lesion primary patency
Target lesion primary patency refers to the treated lesion site remaining open and unobstructed without the need for any additional revascularization procedure during the follow-up period.
Measured: 1-month；6-month；12-month；18-month；24-month
target lesion assisted primary patency
Target lesion assisted primary patency refers to the treated lesion site remaining patent (open) during the follow-up period, but requiring an additional revascularization procedure, such as percutaneous transluminal angioplasty, to maintain patency of the target lesion.
Measured: 1-month；6-month；12-month；18-month；24-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (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 RenJi HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454396
- Sponsor's protocol ID
- The AVF study
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Clinical Study Based on a Decentralized Arteriovenous Endovascular Fistula Data System - Effectiveness and Health Economics of Endoluminal Treatment of Autologous Arteriovenous Endovascular Fistula Failure
- ClinicalTrials.gov ID
- NCT06454396
- Acronym / sponsor ID
- The AVF study
- Conditions
- Hemodialysis Access Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Jun 2024 (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 study was aimed at evaluating the efficacy of different endovascular treatments for early and mid-stage clinical interventions in patients with autologous arteriovenous fistulae loss of function and the corresponding health economic value.
Detailed description
This is a prospective, single-center, real-world study intended to understand the clinical intervention efficacy and health economic value of various real-world endovascular treatments for autologous arteriovenous endovascular fistulae failure in a target lesion defined as the hemodialysis access inflow tract (arterial, anastomotic, and inflection), intermediate segment, and outflow tract vein. The study will enroll 480 patients with autologous arteriovenous endovascular fistulae that have failed during the period 2023/1-2024/12, in a single center. They will be divided into subgroups according to different treatment modalities, such as balloon dilatation alone group, medicated balloon group, and stent implantation group. The main observations were the technical success rate of various endoluminal treatment methods, perioperative major adverse events, and symptom-driven target lesion re-intervention rate, target vessel patency rate, and total hospitalization expenditures related to the target lesion at 1, 6, 12, 18, and 24 months after the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dysfunctional autogenous arteriovenous fistula patient: A stenosis in a hemodialysis access with significant hemodynamic changes: Based on angiography/ultrasound evaluation, the target lesion stenosis is ≥50%, and is accompanied by one or more of the following clinical and physiological abnormalities: natural fistula blood flow <480ml/min; unable to meet the required blood flow for the dialysis prescription; thrombosis in the autogenous arteriovenous fistula; elevated venous pressure during dialysis; difficult cannulation; decreased dialysis adequacy; and abnormal signs in the fistula, etc.
Key inclusion criteria (5 listed)
- Hemodialysis patients over 18 years of age and under 80 years of age
- Autologous arteriovenous fistula cannot be used in patients completing haemodialysis
- The guidewire must pass through at least the stenosis of the endovascular fistula on the side of the lesion and undergo further endovascular treatment before enrolment, and this study does not limit the form of the guidewire passing through the target lesion.
- Patients who have failed to open the initial target lesion and are successful on a second attempt at endoluminal therapy may still be enrolled.
- Subjects and their legal representatives are able to understand the purpose of the study, participate voluntarily and sign an informed consent form, and are willing to be followed up at specific points in time.
Key exclusion criteria (8 listed)
- Planned kidney transplant or conversion to peritoneal dialysis
- Women who are pregnant, breastfeeding or planning to become pregnant during the study period
- Recent (within 30 days) or planned surgical procedure for haemodialysis access
- Allergy or contraindication to heparin, contrast media, antiplatelet drugs
- Patients who have participated in a clinical trial of a drug or other medical device that interferes with this clinical trial within the last 3 months.
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 |
|---|---|---|
| Endovascular therapyEndovascular therapy is a minimally invasive interventional approach that utilizes the vascular system as a pathway to access and treat various pathological conditions within the body. By employing specialized catheters and devices, endovascular techniques enable precise delivery of therapeutic agents or interventional procedures directly to the target site, without the need for conventional open surgery. | Procedure or surgery | – |
Primary outcome
Clinically-driven target lesion re-intervention
Time frame: 1-month；6-month；12-month；18-month；24-month
Clinically-driven target lesion re-intervention refers to a repeat procedure performed on a previously treated lesion due to the recurrence of symptoms or other clinical indications, rather than being routinely scheduled.
2 secondary outcomes
target lesion primary patency
Time frame: 1-month；6-month；12-month；18-month；24-month
target lesion assisted primary patency
Time frame: 1-month；6-month；12-month；18-month；24-month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodialysis Access Failure, run by RenJi Hospital at 1 site in China.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 12 Jun 2024. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingpu Zhu (+86-17520505530, a8600809@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically-driven target lesion re-intervention (time frame: 1-month；6-month；12-month；18-month；24-month). 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 12 Jun 2024.