Vascular Graft Anastomotic StenosisPhase 4NCT02706444
Drug-coated Balloon Versus Conventional Balloon Angioplasty in Hemodialysis Graft
A Phase 4 study testing Conventional Balloon angioplasty and Drug-coated Balloon angioplasty in people with Vascular Graft Anastomotic Stenosis, run by Konkuk University Medical Center.
Trial summary
To evaluate the role of DCB angioplasty for venous anastomotic stenosis of hemodialysis graft, investigators would like to perform randomized study comparing the results of drug- coated balloon angioplasty with conventional balloon angioplasty in the treatment in venous anastomotic stenosis of AVG in terms of patency. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Vascular Graft Anastomotic Stenosis
- What is being tested?
- Conventional Balloon angioplasty and Drug-coated Balloon angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Feb 2018
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of more than 19
- Hemodialysis patients with AVG in their arms: Graft should be implanted 30 days ago before enrollment
- Vascular access actively used for hemodialysis: At least one hemodialysis successful session before enrollment.
- Clinical signs of access dysfunction: decreased thrill, increased pulsatility, development collateral veins, limb swelling, difficulty in cannulation, prolonged bleeding after hemodialysis, high venous pressure or decreased hemodialysis flow rate during hemodialysis.
- > 50% venous anastomotic stenosis of AVG, confirmed by fistulogram (angiography).
- ≦ 4cm from venous anastomosis site in lesion length
- Reference diameter < 7mm of non-stenotic vessel or graft adjacent to venous stenosis.
- Full expansion of conventional balloon during primary balloon angioplasty, confirmed by fluoroscopy.
Who cannot join
- Patients unable to provide informed consent
- Patient unable to abide with study follow-up protocol.
- Patient participating in other relevant or conflicting studies
- Bare metal stent or stent-graft placed previously
- Hemodynamically significant stenosis of the central venous system
- ≧50% stenosis in arterial anastomotic site or venous outflow tract, non including venous anastomosis site
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- Stenosis with a corresponding thrombosis treated within 7 days before enrollment.
- Limited life expectancy less than 6 months
- Sepsis or active infection.
- Recent arm thrombophlebitis (< 6months).
- Allergy or other known contraindication to iodinated contrast media, heparin, or paclitaxel
- Pregnancy or Nursing state
About this study
Official title: A Prospective, Multicenter, Randomized, Controlled Trial for Comparison of Drug-coated Balloon Versus Conventional Balloon Angioplasty in Venous Anastomotic Stenosis of Hemodialysis Graft
To evaluate the role of DCB angioplasty for venous anastomotic stenosis of hemodialysis graft, investigators would like to perform randomized study comparing the results of drug- coated balloon angioplasty with conventional balloon angioplasty in the treatment in venous anastomotic stenosis of AVG in terms of patency.
Read the detailed description
Study Procedure The Interventional angiographic suit will follow the standard hemodialysis related interventional procedure for PTA. Fistulogram will be performed prior to PTA. All enrolled patients should undergo 3 and 6-month follow-up fistulogram and information will be collected and recorded on the treated study vessel and pictures through angiographic image. These data will be recorded on clinical recording form using an excel program.
- Pretreatment evaluation 1.1 All procedures will be performed after obtaining written informed consent from patients. No specific pre-treatment regimen will be needed. 1.2 After sterile preparation and draping, percutaneous access will be gained in an appropriately chosen hemodialysis graft after application of local anesthesia. Diagnostic fistulogram was performed to identify and evaluate the target lesion and any possible secondary lesions. In case of thrombotic occlusion of AVG, diagnostic fistulogram will be done after successful aspiration thrombectomy though a sheath. 1.3 All lesions were characterized by location, length, and degree of stenosis. The degree of stenoses was evaluated in two orthogonal planes, and the greatest degree of stenoses was used for subsequent anatomic measurements. Anatomic measurements were made with use of a calibrated reference marker or software within the angiographic imaging system. The reference vessel was defined as an adjacent segment of normal vein or graft located adjacent to the target lesion. The degree of stenosis was reported as the maximum diameter reduction compared with the reference vessel diameter.
- PTA in venous anastomosis of AVG 2.1 Vascular sheaths will be used in all cases. 2.2 Balloon diameter will be chosen at the operator's discretion, generally starting with a balloon 10% oversized compared with the adjacent normal vein or graft in both groups (Reference Vessel Diameter: RVD). 2.3 Balloon length will be also chosen at the discretion of the operator: In general, 4-cm- or 6cm-long balloons can be used for some long lesions. 2.4 If patient requested the sedation, conscious sedation can be done. 2.5 After crossing the stenosis with a guide wire, the conventional balloon catheter was appropriately positioned across the lesion under fluoroscopic guidance. With the use of an inflation device with a pressure gauge, the balloon catheter was gradually inflated until the stenosis was eliminated. 2.6 Randomization will be assigned after successful conventional balloon angioplasty in venous anastomotic stenosis of AVG. After conventional angioplasty, patients will be randomly assigned to undergo DEB angioplasty or to receive conventional balloon angioplasty for 3 minutes (upto norminal pressure). 2.7 If the patient will be randomly assigned to the DEB group, an In.Pact® Drug-eluting balloon catheter (6, 7mm in diameter, ≦6cm in length) will be used in addition to conventional balloon angioplasty. A balloon diameter and length will be equal to that used in the conventional balloon angioplasty group.
- Procedure Materials PRODUCT SIZE LENGTHS Drug Eluting balloon In.Pact® 6,7mm 4, 6cm Conventional balloon Various conventional balloon catheter 6,7mm 4, 6cm
- Follow-up
- All patients will be followed after PTA. When patients visit hemodialysis unit 3 and 6 months after PTA, the patient's record will be updated.
- All patients that visit hemodialysis unit will be brought to angiographic suit to undergo follow-up fistulogram and evaluate the re-stenosis.
- Clinical follow-up will be performed in hemodialysis unit, including checking the status of hemodialysis using a those circuits and general work-up.
- Conditions
- Vascular Graft Anastomotic Stenosis
- Being tested
- Conventional Balloon angioplasty, Drug-coated Balloon angioplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional Balloon angioplastyDevice
After fistulogram, full expansion of drug-coated balloon catheter under fluoroscopy guidance in > 50% venous anastomotic stenosis of hemodialysis graft and ≦4cm from venous anastomosis site in lesion length, confirmed by fistulogram. Then, participants were divided into two groups (Conventional balloon angioplasty or Drug-coated balloon angioplasty)
Drug-coated Balloon angioplastyDevice
After fistulogram, full expansion of drug-coated balloon catheter under fluoroscopy guidance in > 50% venous anastomotic stenosis of hemodialysis graft and ≦4cm from venous anastomosis site in lesion length, confirmed by fistulogram. Then, participants were divided into two groups (Conventional balloon angioplasty or Drug-coated balloon angioplasty)
| Study group | Role | What they receive |
|---|---|---|
| Conventional Balloon Angioplasty | Active comparator | Conventional balloon angioplasty. After fistulogram, full expansion of conventional balloon catheter under fluoroscopy guidance in > 50% venous anastomotic stenosis of hemodialysis graft and ≦4cm from venous anastomosis site in lesion length, confirmed by fistulogram Receives: Device: Conventional Balloon angioplasty |
| Drug-Coated Balloon Angioplasty | Active comparator | Drug-coated balloon angioplasty. After fistulogram, full expansion of drug-coated balloon catheter under fluoroscopy guidance in > 50% venous anastomotic stenosis of hemodialysis graft and ≦4cm from venous anastomosis site in lesion length, confirmed by fistulogram Receives: Device: Drug-coated Balloon angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency (Fistulogram can be used for measurement of stenosis)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionSep 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Graft Anastomotic StenosisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Woo Park, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706444
- Sponsor's protocol ID
- KUH1140101
- Status last verified
- Mar 2016
- First submitted
- 5 Nov 2015
- Last updated
- 11 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Controlled Trial for Comparison of Drug-coated Balloon Versus Conventional Balloon Angioplasty in Venous Anastomotic Stenosis of Hemodialysis Graft
- ClinicalTrials.gov ID
- NCT02706444
- Acronym / sponsor ID
- KUH1140101
- Conditions
- Vascular Graft Anastomotic Stenosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 11 Mar 2016 (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.
To evaluate the role of DCB angioplasty for venous anastomotic stenosis of hemodialysis graft, investigators would like to perform randomized study comparing the results of drug- coated balloon angioplasty with conventional balloon angioplasty in the treatment in venous anastomotic stenosis of AVG in terms of patency.
Detailed description
Study Procedure The Interventional angiographic suit will follow the standard hemodialysis related interventional procedure for PTA. Fistulogram will be performed prior to PTA. All enrolled patients should undergo 3 and 6-month follow-up fistulogram and information will be collected and recorded on the treated study vessel and pictures through angiographic image. These data will be recorded on clinical recording form using an excel program.
- Pretreatment evaluation 1.1 All procedures will be performed after obtaining written informed consent from patients. No specific pre-treatment regimen will be needed. 1.2 After sterile preparation and draping, percutaneous access will be gained in an appropriately chosen hemodialysis graft after application of local anesthesia. Diagnostic fistulogram was performed to identify and evaluate the target lesion and any possible secondary lesions. In case of thrombotic occlusion of AVG, diagnostic fistulogram will be done after successful aspiration thrombectomy though a sheath. 1.3 All lesions were characterized by location, length, and degree of stenosis. The degree of stenoses was evaluated in two orthogonal planes, and the greatest degree of stenoses was used for subsequent anatomic measurements. Anatomic measurements were made with use of a calibrated reference marker or software within the angiographic imaging system. The reference vessel was defined as an adjacent segment of normal vein or graft located adjacent to the target lesion. The degree of stenosis was reported as the maximum diameter reduction compared with the reference vessel diameter.
- PTA in venous anastomosis of AVG 2.1 Vascular sheaths will be used in all cases. 2.2 Balloon diameter will be chosen at the operator's discretion, generally starting with a balloon 10% oversized compared with the adjacent normal vein or graft in both groups (Reference Vessel Diameter: RVD). 2.3 Balloon length will be also chosen at the discretion of the operator: In general, 4-cm- or 6cm-long balloons can be used for some long lesions. 2.4 If patient requested the sedation, conscious sedation can be done. 2.5 After crossing the stenosis with a guide wire, the conventional balloon catheter was appropriately positioned across the lesion under fluoroscopic guidance. With the use of an inflation device with a pressure gauge, the balloon catheter was gradually inflated until the stenosis was eliminated. 2.6 Randomization will be assigned after successful conventional balloon angioplasty in venous anastomotic stenosis of AVG. After conventional angioplasty, patients will be randomly assigned to undergo DEB angioplasty or to receive conventional balloon angioplasty for 3 minutes (upto norminal pressure). 2.7 If the patient will be randomly assigned to the DEB group, an In.Pact® Drug-eluting balloon catheter (6, 7mm in diameter, ≦6cm in length) will be used in addition to conventional balloon angioplasty. A balloon diameter and length will be equal to that used in the conventional balloon angioplasty group.
- Procedure Materials PRODUCT SIZE LENGTHS Drug Eluting balloon In.Pact® 6,7mm 4, 6cm Conventional balloon Various conventional balloon catheter 6,7mm 4, 6cm
- Follow-up
- All patients will be followed after PTA. When patients visit hemodialysis unit 3 and 6 months after PTA, the patient's record will be updated.
- All patients that visit hemodialysis unit will be brought to angiographic suit to undergo follow-up fistulogram and evaluate the re-stenosis.
- Clinical follow-up will be performed in hemodialysis unit, including checking the status of hemodialysis using a those circuits and general work-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Balloon Angioplasty | Active comparator | Device: Conventional Balloon angioplastyConventional balloon angioplasty. After fistulogram, full expansion of conventional balloon catheter under fluoroscopy guidance in > 50% venous anastomotic stenosis of hemodialysis graft and ≦4cm from venous anastomosis site in lesion length, confirmed by fistulogram |
| Drug-Coated Balloon Angioplasty | Active comparator | Device: Drug-coated Balloon angioplastyDrug-coated balloon angioplasty. After fistulogram, full expansion of drug-coated balloon catheter under fluoroscopy guidance in > 50% venous anastomotic stenosis of hemodialysis graft and ≦4cm from venous anastomosis site in lesion length, confirmed by fistulogram |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age of more than 19
- Hemodialysis patients with AVG in their arms: Graft should be implanted 30 days ago before enrollment
- Vascular access actively used for hemodialysis: At least one hemodialysis successful session before enrollment.
- Clinical signs of access dysfunction: decreased thrill, increased pulsatility, development collateral veins, limb swelling, difficulty in cannulation, prolonged bleeding after hemodialysis, high venous pressure or decreased hemodialysis flow rate during hemodialysis.
- > 50% venous anastomotic stenosis of AVG, confirmed by fistulogram (angiography).
Key exclusion criteria (12 listed)
- Patients unable to provide informed consent
- Patient unable to abide with study follow-up protocol.
- Patient participating in other relevant or conflicting studies
- Bare metal stent or stent-graft placed previously
- Hemodynamically significant stenosis of the central venous system
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 |
|---|---|---|
| Conventional Balloon angioplastyAfter fistulogram, full expansion of drug-coated balloon catheter under fluoroscopy guidance in > 50% venous anastomotic stenosis of hemodialysis graft and ≦4cm from venous anastomosis site in lesion length, confirmed by fistulogram. Then, participants were divided into two groups (Conventional balloon angioplasty or Drug-coated balloon angioplasty) | Device | Conventional Balloon Angioplasty |
| Drug-coated Balloon angioplastyAfter fistulogram, full expansion of drug-coated balloon catheter under fluoroscopy guidance in > 50% venous anastomotic stenosis of hemodialysis graft and ≦4cm from venous anastomosis site in lesion length, confirmed by fistulogram. Then, participants were divided into two groups (Conventional balloon angioplasty or Drug-coated balloon angioplasty) | Device | Drug-Coated Balloon Angioplasty |
Primary outcome
Primary patency (Fistulogram can be used for measurement of stenosis)
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conventional Balloon angioplasty and Drug-coated Balloon angioplasty in people with Vascular Graft Anastomotic Stenosis, run by Konkuk University Medical Center.
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 8 inclusion and 12 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 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency (Fistulogram can be used for measurement of stenosis) (time frame: 6 months). 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 11 Mar 2016.