Arterio-venous FistulaSEMPER FINCT04381754
Use of Implanting the Biotronik Passeo-18 Lux Drug Coated Balloon to Treat Failing Haemodialysis Arteriovenous Fistulas and Grafts.
An observational study of Arterio-venous Fistula and Dialysis Access Malfunction, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The most common problem with haemodialysis arteriovenous fistulas (AVF) and arterio-venous grafts (AVG) is stenosis, which can lead to inadequate dialysis, and eventual access thrombosis. Conventional plain old balloon angioplasty is associate with high recurrence rates of stenosis and repeated interventions. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Arterio-venous Fistula, Dialysis Access Malfunction, Hemodialysis Access Failure
- What is being tested?
- Passeo-18 Lux
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- Jun 2020to Jun 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have a native upper limb AVF or AVG, that is currently in use for haemodialysis, which has a significant inflow or outflow stenosis. Significant stenosis defined as diameter greater than 50% compared to adjacent normal segment and/or other evidence of AVF malfunction. Malfunction defined as the AVF performing inadequate dialysis and clinical signs of a failing dialysis access. Inadequate fistula volume flow - Qa as measured by ultrasound < 500mL/min as probably inadequate. Dialysis numbers: - Qb - a significant stenosis is suggested when the pump speed is < 200ml/min, venous pressure is > 140 mmHg and/or arterial pressure > - 100mmHg. Maximum of 2 discrete stenoses (separated by > 3cm) are allowed to be included.
Who may be able to join
- Patient aged ≥21 years and ≤90 years
- Native AVF was created more than 2 months prior to the index procedure and had undergone 10 or more hemodialysis sessions utilizing 2 needles
- Target lesion location had to be located between the anastomosis to the axillary-subclavian vein junction, as defined by insertion of the cephalic vein.
- On initial fistulogram, target lesion stenosis had to be >50% on angiographic assessment and in keeping with the clinical indicator for intervention
- Stenosis had to be < 10cm in length to allow for potential treatment with one PCB (length 12 cm) only
- Stenosis had to be initially treated successfully with a high-pressure plain balloon prior to PCB treatment as defined by:
Show all 12Show fewer
- No clinically significant dissection
- No extravasation requiring treatment/stenting
- Residual stenosis ≤20% by angiographic measurement
- Ability to completely efface the lesion waist using the pre-dilation balloon
- No more than one additional ("nontarget") lesions in the access circuit that had to be also successfully treated (≤30% residual stenosis) before drug elution. Separate lesion was defined by at least 3 cm in distance from the target lesion.
- Reference vessel diameter 4mm - 8mm
Who cannot join
- Women who were pregnant, lactating, or planning on becoming pregnant during the study
- Subject had more than two lesions in the access circuit
- Subject had a secondary non-target lesion that could not be successfully treated
- Sepsis or active infection
- Asymptomatic target lesions
- A thrombosed access or an access with thrombosis treated ≤30 days prior to the index procedure
Show all 17Show fewer
- Surgical revision of the access site performed, planned or expected ≤ 3 months before or after the index procedure
- Patients who were taking immunosuppressive therapy or are routinely taking ≥ 15 mg of prednisone per day;
- Currently participating in an another investigational drug, biologic, or device study involving sirolimus or paclitaxel
- Contraindication to aspirin or clopidogrel usage
- Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, or language barrier such that the subject is unable to give informed consent
- Uncooperative attitude or potential for non-compliance with the requirements of the protocol making study participation impractical
- Where final angioplasty treatment requires a stent or drug eluting balloon > 8mm in diameter
- Metastatic cancer or terminal medical condition
- Blood coagulation disorders
- Limited life expectancy (< 12 months)
- Allergy or other known contraindication to iodinated media contrast, heparin or paclitaxel
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Implanting the Biotronik Passeo-18 Lux Drug Coated Balloon to Treat Failing Hemodialysis Arteriovenous Fistulas and Grafts
The most common problem with haemodialysis arteriovenous fistulas (AVF) and arterio-venous grafts (AVG) is stenosis, which can lead to inadequate dialysis, and eventual access thrombosis. Conventional plain old balloon angioplasty is associate with high recurrence rates of stenosis and repeated interventions. The advent of successful drug-eluting technology in the treatment of the coronary vascular bed and subsequent positive accumulating evidence in the peripheral arterial circulation has prompted the use of drug coated balloons (DCB) in the access fistula circuit for venous stenosis and in-stent restenosis. Recent studies suggest that DCBs may significantly reduce re-intervention rates on native and recurrent lesions. The restenosis process is in part or in whole the result of neo-intimal hyperplasia (NIH) and NIH is considered the main culprit in access circuit target lesion stenosis. NIH is the blood vessel's healing response to the barotrauma from the angioplasty process. A critical component of NIH is the cellular proliferative stage with mononuclear leucocytes identified as the primary inflammatory cell type involved. The rationale for drug elution is to block the NIH response with an anti-metabolite such as paclitaxel. It is important to emphasize that the role of drug elution in the treatment of vascular stenosis is not to obtain a good haemodynamic and luminal result but to preserve a good result obtained during POBA from later restenosis due to NIH and minimise reinterventions and readmissions to hospital for what is a frail population of patients.
A meta-analysis performed by Khawaja et al. seemed to suggest that DCBs conferred some benefit in terms of improving target lesion primary patency (TLPP) in AVFs. An updated meta-analysis performed by our own institution recently showed that DCB appears to be a better and safe alternative to conventional balloon angioplasty (CBA) in treating patients with HD stenosis based on 6- and 12-months primary patency and increased intervention free period.
The Passeo-18 Lux (Biotronik Asia Pacific Pte Ltd (Singapore)) drug-coated balloon (DCB) is packaged with a low dose of paclitaxel. Recent studies have shown that low dose coating of paclitaxel with this DCB is useful for preventing restenosis, decrease lumen loss and target lesion revascularization in the peripheral vasculature6 but has not been tested in the dialysis access circuit.
- Conditions
- Arterio-venous Fistula, Dialysis Access Malfunction, Hemodialysis Access Failure, Arteriovenous Graft Stenosis
- Being tested
- Passeo-18 Lux
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passeo-18 LuxDevice
Also called Biotronik
Patients with significant inflow or outflow stenosis between the anastomosis to the axillary-subclavian vein junction, as defined by the insertion of the cephalic vein, who had undergone fistuloplasty with Passeo-18 Lux
| Study group | Role | What they receive |
|---|---|---|
| AVG/AVF Treated with Passeo-18 Lux | Patients with failing dialysis access, treated lesions located between the anastomosis to the axillary-subclavian vein junction. Receives: Device: Passeo-18 Lux |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month Target Lesion Primary Patency
Patency with no re-intervention to the area 5mm proximal to, within, and 5mm distal to, the index treatment segment. TLPP ends when any of the following occur: 1) clinically driven re-intervention to the treatment segment 2) thrombotic occlusions that includes the treatment segment 3) surgical intervention that excludes the treatment segment from the access circuit 4) abandonment of the AVF/AVG due to an inability to treat the treatment segment
Measured: 6-month post-procedure
Secondary outcomes (5)
Primary Patency
A duration of time measuring intra-access patency that starts from the date of angioplasty with Passeo-18 Lux DCB to the date of one of the following events: thrombosis, or any intervention to facilitate, maintain or re-establish patency (e.g. angioplasty)
Measured: 12 months post-op
Primary assisted patency
Interval date of angioplasty with Passeo-18 Lux DCB until thrombosis
Measured: 12 months post-op
Secondary Patency
A duration of time measuring intra-access patency that starts from the date of angioplasty with Passeo-18 Lux DCB to the date of vascular access abandonment
Measured: 12 months post-op
Number of reinterventions
Measured: 12 months post-op
Adverse Events
Intraoperative/perioperative complications, infections, revision surgeries required
Measured: 12 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study startJun 2020 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Arterio-venous FistulaStudies of the same condition, open and under way.
- More trials run by Singapore General 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
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tang Tjun Yip, Principal investigator, Sinapore General HospitalYap Hao Yun, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381754
- Sponsor's protocol ID
- 1.5
- Acronym
- SEMPER FI
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Troisi N, Frosini P, Somma C, Romano E, Guidotti A, Dattolo PC, Ferro G, Chisci E, Michelagnoli S. Drug-coated balloons reduce the risk of recurrent restenosis in arteriovenous fistulas and prosthetic grafts for hemodialysis. Int Angiol. 2018 Feb;37(1):59-63. doi: 10.23736/S0392-9590.17.03886-X. Epub 2017 Nov 10.
PubMed 29125264Liao MT, Chen MK, Hsieh MY, Yeh NL, Chien KL, Lin CC, Wu CC, Chie WC. Drug-coated balloon versus conventional balloon angioplasty of hemodialysis arteriovenous fistula or graft: A systematic review and meta-analysis of randomized controlled trials. PLoS One. 2020 Apr 14;15(4):e0231463. doi: 10.1371/journal.pone.0231463. eCollection 2020.
PubMed 32287283Kennedy SA, Mafeld S, Baerlocher MO, Jaberi A, Rajan DK. Drug-Coated Balloon Angioplasty in Hemodialysis Circuits: A Systematic Review and Meta-Analysis. J Vasc Interv Radiol. 2019 Apr;30(4):483-494.e1. doi: 10.1016/j.jvir.2019.01.012. Epub 2019 Mar 8.
PubMed 30857987Khawaja AZ, Cassidy DB, Al Shakarchi J, McGrogan DG, Inston NG, Jones RG. Systematic review of drug eluting balloon angioplasty for arteriovenous haemodialysis access stenosis. J Vasc Access. 2016 Mar-Apr;17(2):103-10. doi: 10.5301/jva.5000508. Epub 2016 Feb 5.
PubMed 26847736Yan Wee IJ, Yap HY, Hsien Ts'ung LT, Lee Qingwei S, Tan CS, Tang TY, Chong TT. A systematic review and meta-analysis of drug-coated balloon versus conventional balloon angioplasty for dialysis access stenosis. J Vasc Surg. 2019 Sep;70(3):970-979.e3. doi: 10.1016/j.jvs.2019.01.082.
PubMed 31445651Brodmann M, Zeller T, Christensen J, Binkert C, Spak L, Schroder H, Righini P, Nano G, Tepe G. Real-world experience with a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries: 12-month interim results of the BIOLUX P-III registry first year of enrolment. J Vasc Bras. 2017 Oct-Dec;16(4):276-284. doi: 10.1590/1677-5449.007317.
PubMed 29930661
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Implanting the Biotronik Passeo-18 Lux Drug Coated Balloon to Treat Failing Hemodialysis Arteriovenous Fistulas and Grafts
- ClinicalTrials.gov ID
- NCT04381754
- Acronym / sponsor ID
- SEMPER FI / 1.5
- Conditions
- Arterio-venous Fistula, Dialysis Access Malfunction, Hemodialysis Access Failure, Arteriovenous Graft Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- Jun 2020 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 11 May 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.
The most common problem with haemodialysis arteriovenous fistulas (AVF) and arterio-venous grafts (AVG) is stenosis, which can lead to inadequate dialysis, and eventual access thrombosis. Conventional plain old balloon angioplasty is associate with high recurrence rates of stenosis and repeated interventions. The advent of successful drug-eluting technology in the treatment of the coronary vascular bed and subsequent positive accumulating evidence in the peripheral arterial circulation has prompted the use of drug coated balloons (DCB) in the access fistula circuit for venous stenosis and in-stent restenosis. Recent studies suggest that DCBs may significantly reduce re-intervention rates on native and recurrent lesions. The restenosis process is in part or in whole the result of neo-intimal hyperplasia (NIH) and NIH is considered the main culprit in access circuit target lesion stenosis. NIH is the blood vessel's healing response to the barotrauma from the angioplasty process. A critical component of NIH is the cellular proliferative stage with mononuclear leucocytes identified as the primary inflammatory cell type involved. The rationale for drug elution is to block the NIH response with an anti-metabolite such as paclitaxel. It is important to emphasize that the role of drug elution in the treatment of vascular stenosis is not to obtain a good haemodynamic and luminal result but to preserve a good result obtained during POBA from later restenosis due to NIH and minimise reinterventions and readmissions to hospital for what is a frail population of patients.
A meta-analysis performed by Khawaja et al. seemed to suggest that DCBs conferred some benefit in terms of improving target lesion primary patency (TLPP) in AVFs. An updated meta-analysis performed by our own institution recently showed that DCB appears to be a better and safe alternative to conventional balloon angioplasty (CBA) in treating patients with HD stenosis based on 6- and 12-months primary patency and increased intervention free period.
The Passeo-18 Lux (Biotronik Asia Pacific Pte Ltd (Singapore)) drug-coated balloon (DCB) is packaged with a low dose of paclitaxel. Recent studies have shown that low dose coating of paclitaxel with this DCB is useful for preventing restenosis, decrease lumen loss and target lesion revascularization in the peripheral vasculature6 but has not been tested in the dialysis access circuit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AVG/AVF Treated with Passeo-18 Lux | – | Device: Passeo-18 LuxPatients with failing dialysis access, treated lesions located between the anastomosis to the axillary-subclavian vein junction. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have a native upper limb AVF or AVG, that is currently in use for haemodialysis, which has a significant inflow or outflow stenosis. Significant stenosis defined as diameter greater than 50% compared to adjacent normal segment and/or other evidence of AVF malfunction. Malfunction defined as the AVF performing inadequate dialysis and clinical signs of a failing dialysis access. Inadequate fistula volume flow - Qa as measured by ultrasound < 500mL/min as probably inadequate. Dialysis numbers: - Qb - a significant stenosis is suggested when the pump speed is < 200ml/min, venous pressure is > 140 mmHg and/or arterial pressure > - 100mmHg. Maximum of 2 discrete stenoses (separated by > 3cm) are allowed to be included.
Key inclusion criteria (12 listed)
- Patient aged ≥21 years and ≤90 years
- Native AVF was created more than 2 months prior to the index procedure and had undergone 10 or more hemodialysis sessions utilizing 2 needles
- Target lesion location had to be located between the anastomosis to the axillary-subclavian vein junction, as defined by insertion of the cephalic vein.
- On initial fistulogram, target lesion stenosis had to be >50% on angiographic assessment and in keeping with the clinical indicator for intervention
- Stenosis had to be < 10cm in length to allow for potential treatment with one PCB (length 12 cm) only
Key exclusion criteria (17 listed)
- Women who were pregnant, lactating, or planning on becoming pregnant during the study
- Subject had more than two lesions in the access circuit
- Subject had a secondary non-target lesion that could not be successfully treated
- Sepsis or active infection
- Asymptomatic target lesions
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 |
|---|---|---|
| Passeo-18 LuxAlso: BiotronikPatients with significant inflow or outflow stenosis between the anastomosis to the axillary-subclavian vein junction, as defined by the insertion of the cephalic vein, who had undergone fistuloplasty with Passeo-18 Lux | Device | AVG/AVF Treated with Passeo-18 Lux |
Primary outcome
6-month Target Lesion Primary Patency
Time frame: 6-month post-procedure
Patency with no re-intervention to the area 5mm proximal to, within, and 5mm distal to, the index treatment segment. TLPP ends when any of the following occur: 1) clinically driven re-intervention to the treatment segment 2) thrombotic occlusions that includes the treatment segment 3) surgical intervention that excludes the treatment segment from the access circuit 4) abandonment of the AVF/AVG due to an inability to treat the treatment segment
5 secondary outcomes
Primary Patency
Time frame: 12 months post-op
Primary assisted patency
Time frame: 12 months post-op
Secondary Patency
Time frame: 12 months post-op
Number of reinterventions
Time frame: 12 months post-op
Adverse Events
Time frame: 12 months post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- Background: PubMed 29125264Troisi N, Frosini P, Somma C, Romano E, Guidotti A, Dattolo PC, Ferro G, Chisci E, Michelagnoli S. Drug-coated balloons reduce the risk of recurrent restenosis in arteriovenous fistulas and prosthetic grafts for hemodialysis. Int Angiol. 2018 Feb;37(1):59-63. doi: 10.23736/S0392-9590.17.03886-X. Epub 2017 Nov 10.
- Background: PubMed 32287283Liao MT, Chen MK, Hsieh MY, Yeh NL, Chien KL, Lin CC, Wu CC, Chie WC. Drug-coated balloon versus conventional balloon angioplasty of hemodialysis arteriovenous fistula or graft: A systematic review and meta-analysis of randomized controlled trials. PLoS One. 2020 Apr 14;15(4):e0231463. doi: 10.1371/journal.pone.0231463. eCollection 2020.
- Background: PubMed 30857987Kennedy SA, Mafeld S, Baerlocher MO, Jaberi A, Rajan DK. Drug-Coated Balloon Angioplasty in Hemodialysis Circuits: A Systematic Review and Meta-Analysis. J Vasc Interv Radiol. 2019 Apr;30(4):483-494.e1. doi: 10.1016/j.jvir.2019.01.012. Epub 2019 Mar 8.
- Background: PubMed 26847736Khawaja AZ, Cassidy DB, Al Shakarchi J, McGrogan DG, Inston NG, Jones RG. Systematic review of drug eluting balloon angioplasty for arteriovenous haemodialysis access stenosis. J Vasc Access. 2016 Mar-Apr;17(2):103-10. doi: 10.5301/jva.5000508. Epub 2016 Feb 5.
- Background: PubMed 31445651Yan Wee IJ, Yap HY, Hsien Ts'ung LT, Lee Qingwei S, Tan CS, Tang TY, Chong TT. A systematic review and meta-analysis of drug-coated balloon versus conventional balloon angioplasty for dialysis access stenosis. J Vasc Surg. 2019 Sep;70(3):970-979.e3. doi: 10.1016/j.jvs.2019.01.082.
- Background: PubMed 29930661Brodmann M, Zeller T, Christensen J, Binkert C, Spak L, Schroder H, Righini P, Nano G, Tepe G. Real-world experience with a Paclitaxel-Coated Balloon for the treatment of atherosclerotic infrainguinal arteries: 12-month interim results of the BIOLUX P-III registry first year of enrolment. J Vasc Bras. 2017 Oct-Dec;16(4):276-284. doi: 10.1590/1677-5449.007317.
- 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.
Tang Tjun Yip principal investigator
Sinapore General Hospital
Yap Hao Yun principal investigator
Singapore General Hospital
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 Arterio-venous Fistula and Dialysis Access Malfunction, run by Singapore General Hospital at 1 site in Singapore.
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 12 inclusion and 17 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 May 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 Singapore. 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?
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?
6-month Target Lesion Primary Patency (time frame: 6-month post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04381754, which also lists 6 linked publications.
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 May 2020.