UremiaSAVEITNCT02266238
Stenosis of Arteria-Venous Fistula in Maintenance Hemodialysis Patients: Early Intervention Trial
A study testing DSA guided percutaneous balloon dilatation, Ultrasound guided percutaneous balloon dilatation and Surgical reconstruction in people with Uremia and Arteriovenous Fistula, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
The purpose of this study is to compare the effect of DSA guided percutaneous balloon dilatation, ultrasound guided percutaneous balloon dilatation and surgical repair in the treatment of Stenosis of Arteria-Venous Fistula in Maintenance Hemodialysis Patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Uremia, Arteriovenous Fistula, Stenosis
- What is being tested?
- DSA guided percutaneous balloon dilatation, Ultrasound guided percutaneous balloon dilatation and Surgical reconstruction
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Dec 2017
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with long-term maintenance hemodialysis with AVF as the vascular access;
- Positive clinical examination signs of AVF stenosis （not all required） : (1) the visual examination: edema, prolonged bleeding time, hematoma, aneurysm or constriction of the fistula .(2) the palpation examination: a narrowing of the outflow vein or aneurysm formation. (3) the auscultation examination: high pitch and/or discontinuous murmur;
- Doppler ultrasound /DSA/MRA show the diameter of AVF fistula is >50% narrow than the adjacent segment of the fistula lumen;
- Blood flow of the AVF is <500ml/min or monthly declines of the blood flow>25%;
- Patient signed the informed consent.
Who cannot join
- allergic to the iodine contrast or gadolinium contrast agent;
- local infection;
- the presence of severe coagulation dysfunction (or long-term history of taking warfarin or ticlopidine);
- the presence of severe artery steal syndrome;
- stenosis of immature fistula or fistula <2 month after vascular anastomosis;
- severe central venous stenosis;
Show all 11Show fewer
- discontinue hemodialysis treatment (such as to transfer to peritoneal dialysis or kidney transplant);
- severe cardiac dysfunction (New York Heart Association cardiac functional classification III or worse), unstable angina pectoris, myocardial infarction, severe left ventricular hypertrophy, or severe vascular embolic disease;
- participated in other clinical trials within 12 weeks;
- alcohol and/or drug abusers, mental disorders;
- patients not suitable as the subjects of this trial under the consideration of researchers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial to Compare Therapeutic Effect of Digital Subtraction Angiography(DSA)，Ultrasound Guided Balloon Dilatation and Surgical Reconstruction in Arteria-venous Fistula(AVF) Stenosis in Maintenance Hemodialysis Patients
The purpose of this study is to compare the effect of DSA guided percutaneous balloon dilatation, ultrasound guided percutaneous balloon dilatation and surgical repair in the treatment of Stenosis of Arteria-Venous Fistula in Maintenance Hemodialysis Patients.
Read the detailed description
Eligibility Criteria:
- Patients with long-term maintenance hemodialysis with AVF as the vascular access;
- Positive clinical examination signs of AVF stenosis （not all required） : (1) the visual examination: edema, prolonged bleeding time, hematoma, aneurysm or constriction of the fistula .(2) the palpation examination: a narrowing of the outflow vein or aneurysm formation. (3) the auscultation examination: high pitch and/or discontinuous murmur.
- Doppler ultrasound /DSA/magnetic resonance angiography show the diameter of AVF fistula is >50% narrow than the adjacent segment of the fistula lumen.
- Blood flow of the AVF is <500ml/min or monthly declines of the blood flow>25%.
- Patient signed the informed consent.
- Conditions
- Uremia, Arteriovenous Fistula, Stenosis
- Being tested
- DSA guided percutaneous balloon dilatation, Ultrasound guided percutaneous balloon dilatation, Surgical reconstruction
- Medical subject headings
- Uremia, Arteriovenous Fistula, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DSA guided percutaneous balloon dilatationDevice
Under the guidance of DSA, balloon is introduced into the stenosis area, proper pressure is given to achieve balloon dilatation to expand the narrow AVF lumen.
Ultrasound guided percutaneous balloon dilatationDevice
Under the guidance of ultrasound, balloon is introduced into the stenosis area, proper pressure is given to achieve balloon dilatation to expand the narrow AVF lumen.
Surgical reconstructionProcedure or surgery
Direct surgery to reconstruction the AVF lumen.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | DSA guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula Receives: Device: DSA guided percutaneous balloon dilatation |
| Group 2 | Experimental | Ultrasound guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula Receives: Device: Ultrasound guided percutaneous balloon dilatation |
| Group 3 | Experimental | Surgical reconstruction of the stenosis to reconstruction the lumen of arteriovenous fistula Receives: Procedure: Surgical reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
the patency rate of the AVF after intervention
the patency rate including the primary and the secondary patency rate
Measured: 24 month
Secondary outcomes (4)
The success rate of AVF stenosis interventions
Described as %.
Measured: 24 month
The recurrence rate of AVF stenosis interventions
Described as %.
Measured: 24 month
The side effects of AVF stenosis interventions
Described as %.Side effects including bleeding, infection, thrombosis, artery steal syndrome, heart failure, inadequate dialysis, etc.
Measured: 24 month
The cost-effectiveness analysis of AVF stenosis interventions
Described as $.
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study startJan 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UremiaStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Zhongda Hospital, The First Affiliated Hospital of Zhengzhou University, Sichuan Provincial People's Hospital, The Second Affiliated Hospital of Dalian Medical University, Beijing Haidian Hospital
- Responsible party
- Principal investigator, Changlin Mei, Shanghai Changzheng Hospital
- Investigators
- Changlin Mei, MD, Principal investigator, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02266238
- Sponsor's protocol ID
- CZHKI-HDVA-003
- Acronym
- SAVEIT
- Status last verified
- Oct 2014
- First submitted
- 22 Sep 2014
- Last updated
- 16 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Compare Therapeutic Effect of Digital Subtraction Angiography(DSA)，Ultrasound Guided Balloon Dilatation and Surgical Reconstruction in Arteria-venous Fistula(AVF) Stenosis in Maintenance Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT02266238
- Acronym / sponsor ID
- SAVEIT / CZHKI-HDVA-003
- Conditions
- Uremia, Arteriovenous Fistula, Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital of Zhejiang University, Zhongda Hospital, The First Affiliated Hospital of Zhengzhou University, Sichuan Provincial People's Hospital, The Second Affiliated Hospital of Dalian Medical University, Beijing Haidian Hospital
- Study start
- Jan 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 16 Oct 2014 (estimated)
- 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.
The purpose of this study is to compare the effect of DSA guided percutaneous balloon dilatation, ultrasound guided percutaneous balloon dilatation and surgical repair in the treatment of Stenosis of Arteria-Venous Fistula in Maintenance Hemodialysis Patients.
Detailed description
Eligibility Criteria:
- Patients with long-term maintenance hemodialysis with AVF as the vascular access;
- Positive clinical examination signs of AVF stenosis （not all required） : (1) the visual examination: edema, prolonged bleeding time, hematoma, aneurysm or constriction of the fistula .(2) the palpation examination: a narrowing of the outflow vein or aneurysm formation. (3) the auscultation examination: high pitch and/or discontinuous murmur.
- Doppler ultrasound /DSA/magnetic resonance angiography show the diameter of AVF fistula is >50% narrow than the adjacent segment of the fistula lumen.
- Blood flow of the AVF is <500ml/min or monthly declines of the blood flow>25%.
- Patient signed the informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: DSA guided percutaneous balloon dilatationDSA guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula |
| Group 2 | Experimental | Device: Ultrasound guided percutaneous balloon dilatationUltrasound guided percutaneous balloon dilatation to expand the stenosis of arteriovenous fistula |
| Group 3 | Experimental | Procedure: Surgical reconstructionSurgical reconstruction of the stenosis to reconstruction the lumen of arteriovenous fistula |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with long-term maintenance hemodialysis with AVF as the vascular access;
- Positive clinical examination signs of AVF stenosis （not all required） : (1) the visual examination: edema, prolonged bleeding time, hematoma, aneurysm or constriction of the fistula .(2) the palpation examination: a narrowing of the outflow vein or aneurysm formation. (3) the auscultation examination: high pitch and/or discontinuous murmur;
- Doppler ultrasound /DSA/MRA show the diameter of AVF fistula is >50% narrow than the adjacent segment of the fistula lumen;
- Blood flow of the AVF is <500ml/min or monthly declines of the blood flow>25%;
- Patient signed the informed consent.
Key exclusion criteria (11 listed)
- allergic to the iodine contrast or gadolinium contrast agent;
- local infection;
- the presence of severe coagulation dysfunction (or long-term history of taking warfarin or ticlopidine);
- the presence of severe artery steal syndrome;
- stenosis of immature fistula or fistula <2 month after vascular anastomosis;
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 |
|---|---|---|
| DSA guided percutaneous balloon dilatationUnder the guidance of DSA, balloon is introduced into the stenosis area, proper pressure is given to achieve balloon dilatation to expand the narrow AVF lumen. | Device | Group 1 |
| Ultrasound guided percutaneous balloon dilatationUnder the guidance of ultrasound, balloon is introduced into the stenosis area, proper pressure is given to achieve balloon dilatation to expand the narrow AVF lumen. | Device | Group 2 |
| Surgical reconstructionDirect surgery to reconstruction the AVF lumen. | Procedure or surgery | Group 3 |
Primary outcome
the patency rate of the AVF after intervention
Time frame: 24 month
the patency rate including the primary and the secondary patency rate
4 secondary outcomes
The success rate of AVF stenosis interventions
Time frame: 24 month
The recurrence rate of AVF stenosis interventions
Time frame: 24 month
The side effects of AVF stenosis interventions
Time frame: 24 month
The cost-effectiveness analysis of AVF stenosis interventions
Time frame: 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2014.
Related trials for Uremia
Active, not recruitingPhase 3
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Atypical Hemolytic Uremic Syndrome
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingObservational study
A Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns and Outcomes in Atypical Hemolytic Uremic Syndrome Patients
Atypical Hemolytic Uremic Syndrome(aHUS)
Active, not recruitingPhase 3
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
Atypical Hemolytic Uremic Syndrome
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.
Changlin Mei, MD principal investigator
Shanghai Changzheng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DSA guided percutaneous balloon dilatation, Ultrasound guided percutaneous balloon dilatation and Surgical reconstruction in people with Uremia and Arteriovenous Fistula, run by Shanghai Changzheng 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 11 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 16 Oct 2014. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Changlin Mei, MD (0086 21 81885411, chlmei1954@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the patency rate of the AVF after intervention (time frame: 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 16 Oct 2014.