Brachiocephalic Vein StenosisArch-VNCT03891693
Biomimetic Stent and Drug Eluting Balloon to Treat Recurrent Cephalic Arch Stenosis
A study testing Passeo-18 Lux and SUPERA® stent in people with Brachiocephalic Vein Stenosis, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The study evaluates the use of a biomimetic stent (SUPERA®) and a drug eluting balloon (DEB - Passeo 18 Lux) for the treatment of recurrent and tight cephalic arch stenosis in patients with brachiocephalic fistulas. All participants will undergo angioplasty with stated devices, and be followed up with over 12 months. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Brachiocephalic Vein Stenosis
- What is being tested?
- Passeo-18 Lux and SUPERA® stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSingapore
- Study dates
- 5 Sep 2018to 30 Jan 2021
- 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 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient's age is above 21 and below 90
- Informed consent obtained
- Chronic background treatment with daily ASA
- Patients with significant Cephalic Arch Vein Stenosis or recurrent stenosis within 6 months of initial POBA diagnosed either clinically or with Duplex Ultrasound
- Post-angioplasty cephalic arch lumen size between 5mm - 7mm maximum diameter
Who cannot join
- Patients with significant central vein stenosis (>70%) or total occlusion at time of angiographic study
- Cephalic arch stenosis <50% stenosis or diameter >5mm
- Patients with previous cephalic arch stenting (Bare Metal Stents or stent graft)
- Concomitant fistula inflow problem (e.g. juxta-anastomotic) that cannot be corrected optimally during the intervention (>30% residual stenosis or angiographic lumen <3mm)
- Patients with minor or major cephalic arch rupture during POBA procedure and the rupture point cannot be adequately sealed off during the procedure requiring a covered stent or open conversion
- Cephalic arch lesion length <10mm or greater than 10cm
Show all 25Show fewer
- Patients with uncontrolled hypertension
- Patient <21 or > 90 years of age.
- Pregnant women or women of childbearing potential who are not following an effective method of contraception.
- Contraindication to aspirin or clopidogrel usage
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences o 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
- Patients who do NOT have impaired renal function
- Occluded or thrombosed fistula
- Patients presenting with central venous stenosis
- Final angioplasty treatment requires a stent or DEB >7mm in diameter
- Multiple lesions in the access circuit that cannot be treated with one stent and DEB.
- Vascular access circuit placed in the lower extremities
- Bare metal stent or stent-graft placed previously
- Metastatic caner or terminal medical condition
- Blood coagulation disorder
- Limited life expectancy (<6 months)
- Sepsis or active infection
- Recent arm thrombophlebitis
- 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: Biomimetic (SUPERA) Stent and Drug Eluting Balloon (Passeo 18 Lux) to Treat Recurrent Cephalic Arch Stenosis
The study evaluates the use of a biomimetic stent (SUPERA®) and a drug eluting balloon (DEB - Passeo 18 Lux) for the treatment of recurrent and tight cephalic arch stenosis in patients with brachiocephalic fistulas. All participants will undergo angioplasty with stated devices, and be followed up with over 12 months.
Read the detailed description
To date, the treatment options are limited for recurrent and tight cephalic arch stenosis in patients with brachiocephalic fistulas - Angioplasty, with or without the placement of a stent, surgical bypass using the internal jugular vein or a cephalic/brachial venous anastomosis, or the creation of a new fistula may be a reasonable option. Angioplasty may be associated with technical failure and rupture of the arch vein in reported incidences of 24% and 6%, respectively. Percutaneous Transluminal Angioplasty (PTA) is associated with very low primary patency rates of 42% and 23% at 6 and 12 months, whilst bare stents are equally poor, with reported patency of 39% and 0% at those same time-point. The use of a biomimetic stent (SUPERA®) in the cephalic arch has not been studied to date, but may not only offer protection from rupture of the arch vein but may also create a material barrier to prevent the development of Neo-Intimal Hyperplasia (NIH). With the additional use of drug elution, this may impede NIH effect even more.
- Conditions
- Brachiocephalic Vein Stenosis
- Being tested
- Passeo-18 Lux and SUPERA® stent
- Keywords
- Stenosis, Angioplasty, Vascular Disease
- Medical subject headings
- Constriction, Pathologic, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passeo-18 Lux and SUPERA® stentDevice
Angioplasty of Arteriovenous Fistula (AVF) performed using Passeo-18 Lux and SUPERA® stent for patients with cephalic arch stenosis
| Study group | Role | What they receive |
|---|---|---|
| Passeo-18 Lux and SUPERA® stent | Experimental | Target lesion will be treated with Passeo-18 Lux Drug Eluting Balloon and SUPERA® stent during angioplasty Receives: Device: Passeo-18 Lux and SUPERA® stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angiographic Success
<30% regional stenosis within the stent and minimal lumen size should reach 5mm
Measured: Immediately post-operation
Functional Fistula
At the following time points, to monitor for any changes in whether fistula can be used successfully for dialysis without the need for re-intervention.
Measured: Post-operation 1 week, 2 months, 6 months and 12 months.
Primary Patency of Cephalic Arch
Less than 50% stenosis observed on duplex ultrasound
Measured: 1 year post-operation
Secondary outcomes (5)
Access Circuit Thrombosis
Thrombosis of access circuit requiring further intervention such as thrombolysis
Measured: 1 year post-operation
Number of re-interventions per year
To note any re-interventions performed post-study procedure
Measured: 1 year post-operation
Access Circuit Restenosis / Stent Fractures
To note any restenosis or stent fractures during study period that requires re-intervention
Measured: 1 year post-operation
Access Circuit Infection
To note any infection at treated fistula during study period
Measured: 1 year post-operation
Need for bypass revision surgery
Measured: 1 year post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start5 Sep 2018
- Primary completion30 Jun 2020
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Brachiocephalic Vein StenosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will be treated with SUPERA® stents and Passeo-18-Lux
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tang Tjun Yip, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03891693
- Sponsor's protocol ID
- 2018/2557
- Acronym
- Arch-V
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2019
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scheinert D, Werner M, Scheinert S, Paetzold A, Banning-Eichenseer U, Piorkowski M, Ulrich M, Bausback Y, Braunlich S, Schmidt A. Treatment of complex atherosclerotic popliteal artery disease with a new self-expanding interwoven nitinol stent: 12-month results of the Leipzig SUPERA popliteal artery stent registry. JACC Cardiovasc Interv. 2013 Jan;6(1):65-71. doi: 10.1016/j.jcin.2012.09.011.
PubMed 23347863Garcia L, Jaff MR, Metzger C, Sedillo G, Pershad A, Zidar F, Patlola R, Wilkins RG, Espinoza A, Iskander A, Khammar GS, Khatib Y, Beasley R, Makam S, Kovach R, Kamat S, Leon LR Jr, Eaves WB, Popma JJ, Mauri L, Donohoe D, Base CC, Rosenfield K; SUPERB Trial Investigators. Wire-Interwoven Nitinol Stent Outcome in the Superficial Femoral and Proximal Popliteal Arteries: Twelve-Month Results of the SUPERB Trial. Circ Cardiovasc Interv. 2015 May;8(5):e000937. doi: 10.1161/CIRCINTERVENTIONS.113.000937.
PubMed 25969545Bishu K, Armstrong EJ. Supera self-expanding stents for endovascular treatment of femoropopliteal disease: a review of the clinical evidence. Vasc Health Risk Manag. 2015 Jul 13;11:387-95. doi: 10.2147/VHRM.S70229. eCollection 2015.
PubMed 26203255Micari A, Brodmann M, Keirse K, Peeters P, Tepe G, Frost M, Wang H, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study. JACC Cardiovasc Interv. 2018 May 28;11(10):945-953. doi: 10.1016/j.jcin.2018.02.019.
PubMed 29798770Zeller T, Beschorner U, Pilger E, Bosiers M, Deloose K, Peeters P, Scheinert D, Schulte KL, Rastan A, Brodmann M. Paclitaxel-Coated Balloon in Infrapopliteal Arteries: 12-Month Results From the BIOLUX P-II Randomized Trial (BIOTRONIK'S-First in Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries). JACC Cardiovasc Interv. 2015 Oct;8(12):1614-22. doi: 10.1016/j.jcin.2015.07.011.
PubMed 26493253Zhang D, Yang R, Wang S, Dong Z. Paclitaxel: new uses for an old drug. Drug Des Devel Ther. 2014 Feb 20;8:279-84. doi: 10.2147/DDDT.S56801. eCollection 2014.
PubMed 24591817Cho SB, Choi HC, Bae E, Park TJ, Baek HJ, Park SE, Ryu KH, Moon JI, Choi BH, Bae K, Jeon KN. Angioplasty and stenting for the proximal anastomotic stenosis of a brachio-axillary bypass graft using a helical interwoven nitinol stent: A case report. Medicine (Baltimore). 2017 Dec;96(50):e9073. doi: 10.1097/MD.0000000000009073.
PubMed 29390303Tang TY, Tan CS, Yap C, Tan RY, Tay HH, Choke E, Chong TT. Helical stent (SUPERA) and drug-coated balloon (Passeo-18 Lux) for recurrent cephalic arch stenosis: Rationale and design of arch V SUPERA-LUX Study. J Vasc Access. 2020 Jul;21(4):504-510. doi: 10.1177/1129729819881589. Epub 2019 Oct 17.
PubMed 31621477
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomimetic (SUPERA) Stent and Drug Eluting Balloon (Passeo 18 Lux) to Treat Recurrent Cephalic Arch Stenosis
- ClinicalTrials.gov ID
- NCT03891693
- Acronym / sponsor ID
- Arch-V / 2018/2557
- Conditions
- Brachiocephalic Vein Stenosis
- Keywords
- Stenosis, Angioplasty, Vascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 27 Mar 2019 (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 study evaluates the use of a biomimetic stent (SUPERA®) and a drug eluting balloon (DEB - Passeo 18 Lux) for the treatment of recurrent and tight cephalic arch stenosis in patients with brachiocephalic fistulas. All participants will undergo angioplasty with stated devices, and be followed up with over 12 months.
Detailed description
To date, the treatment options are limited for recurrent and tight cephalic arch stenosis in patients with brachiocephalic fistulas - Angioplasty, with or without the placement of a stent, surgical bypass using the internal jugular vein or a cephalic/brachial venous anastomosis, or the creation of a new fistula may be a reasonable option. Angioplasty may be associated with technical failure and rupture of the arch vein in reported incidences of 24% and 6%, respectively. Percutaneous Transluminal Angioplasty (PTA) is associated with very low primary patency rates of 42% and 23% at 6 and 12 months, whilst bare stents are equally poor, with reported patency of 39% and 0% at those same time-point. The use of a biomimetic stent (SUPERA®) in the cephalic arch has not been studied to date, but may not only offer protection from rupture of the arch vein but may also create a material barrier to prevent the development of Neo-Intimal Hyperplasia (NIH). With the additional use of drug elution, this may impede NIH effect even more.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will be treated with SUPERA® stents and Passeo-18-Lux
| Arm | Type | Receives |
|---|---|---|
| Passeo-18 Lux and SUPERA® stent | Experimental | Device: Passeo-18 Lux and SUPERA® stentTarget lesion will be treated with Passeo-18 Lux Drug Eluting Balloon and SUPERA® stent during angioplasty |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient's age is above 21 and below 90
- Informed consent obtained
- Chronic background treatment with daily ASA
- Patients with significant Cephalic Arch Vein Stenosis or recurrent stenosis within 6 months of initial POBA diagnosed either clinically or with Duplex Ultrasound
- Post-angioplasty cephalic arch lumen size between 5mm - 7mm maximum diameter
Key exclusion criteria (25 listed)
- Patients with significant central vein stenosis (>70%) or total occlusion at time of angiographic study
- Cephalic arch stenosis <50% stenosis or diameter >5mm
- Patients with previous cephalic arch stenting (Bare Metal Stents or stent graft)
- Concomitant fistula inflow problem (e.g. juxta-anastomotic) that cannot be corrected optimally during the intervention (>30% residual stenosis or angiographic lumen <3mm)
- Patients with minor or major cephalic arch rupture during POBA procedure and the rupture point cannot be adequately sealed off during the procedure requiring a covered stent or open conversion
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 Lux and SUPERA® stentAngioplasty of Arteriovenous Fistula (AVF) performed using Passeo-18 Lux and SUPERA® stent for patients with cephalic arch stenosis | Device | Passeo-18 Lux and SUPERA® stent |
Primary outcome
Angiographic Success
Time frame: Immediately post-operation
<30% regional stenosis within the stent and minimal lumen size should reach 5mm
Functional Fistula
Time frame: Post-operation 1 week, 2 months, 6 months and 12 months.
At the following time points, to monitor for any changes in whether fistula can be used successfully for dialysis without the need for re-intervention.
Primary Patency of Cephalic Arch
Time frame: 1 year post-operation
Less than 50% stenosis observed on duplex ultrasound
5 secondary outcomes
Access Circuit Thrombosis
Time frame: 1 year post-operation
Number of re-interventions per year
Time frame: 1 year post-operation
Access Circuit Restenosis / Stent Fractures
Time frame: 1 year post-operation
Access Circuit Infection
Time frame: 1 year post-operation
Need for bypass revision surgery
Time frame: 1 year post-operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Background: PubMed 23347863Scheinert D, Werner M, Scheinert S, Paetzold A, Banning-Eichenseer U, Piorkowski M, Ulrich M, Bausback Y, Braunlich S, Schmidt A. Treatment of complex atherosclerotic popliteal artery disease with a new self-expanding interwoven nitinol stent: 12-month results of the Leipzig SUPERA popliteal artery stent registry. JACC Cardiovasc Interv. 2013 Jan;6(1):65-71. doi: 10.1016/j.jcin.2012.09.011.
- Background: PubMed 25969545Garcia L, Jaff MR, Metzger C, Sedillo G, Pershad A, Zidar F, Patlola R, Wilkins RG, Espinoza A, Iskander A, Khammar GS, Khatib Y, Beasley R, Makam S, Kovach R, Kamat S, Leon LR Jr, Eaves WB, Popma JJ, Mauri L, Donohoe D, Base CC, Rosenfield K; SUPERB Trial Investigators. Wire-Interwoven Nitinol Stent Outcome in the Superficial Femoral and Proximal Popliteal Arteries: Twelve-Month Results of the SUPERB Trial. Circ Cardiovasc Interv. 2015 May;8(5):e000937. doi: 10.1161/CIRCINTERVENTIONS.113.000937.
- Background: PubMed 26203255Bishu K, Armstrong EJ. Supera self-expanding stents for endovascular treatment of femoropopliteal disease: a review of the clinical evidence. Vasc Health Risk Manag. 2015 Jul 13;11:387-95. doi: 10.2147/VHRM.S70229. eCollection 2015.
- Background: PubMed 29798770Micari A, Brodmann M, Keirse K, Peeters P, Tepe G, Frost M, Wang H, Zeller T; IN.PACT Global Study Investigators. Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study. JACC Cardiovasc Interv. 2018 May 28;11(10):945-953. doi: 10.1016/j.jcin.2018.02.019.
- Background: PubMed 26493253Zeller T, Beschorner U, Pilger E, Bosiers M, Deloose K, Peeters P, Scheinert D, Schulte KL, Rastan A, Brodmann M. Paclitaxel-Coated Balloon in Infrapopliteal Arteries: 12-Month Results From the BIOLUX P-II Randomized Trial (BIOTRONIK'S-First in Man study of the Passeo-18 LUX drug releasing PTA Balloon Catheter vs. the uncoated Passeo-18 PTA balloon catheter in subjects requiring revascularization of infrapopliteal arteries). JACC Cardiovasc Interv. 2015 Oct;8(12):1614-22. doi: 10.1016/j.jcin.2015.07.011.
- Background: PubMed 24591817Zhang D, Yang R, Wang S, Dong Z. Paclitaxel: new uses for an old drug. Drug Des Devel Ther. 2014 Feb 20;8:279-84. doi: 10.2147/DDDT.S56801. eCollection 2014.
- Background: PubMed 29390303Cho SB, Choi HC, Bae E, Park TJ, Baek HJ, Park SE, Ryu KH, Moon JI, Choi BH, Bae K, Jeon KN. Angioplasty and stenting for the proximal anastomotic stenosis of a brachio-axillary bypass graft using a helical interwoven nitinol stent: A case report. Medicine (Baltimore). 2017 Dec;96(50):e9073. doi: 10.1097/MD.0000000000009073.
- Derived from this study: PubMed 31621477Tang TY, Tan CS, Yap C, Tan RY, Tay HH, Choke E, Chong TT. Helical stent (SUPERA) and drug-coated balloon (Passeo-18 Lux) for recurrent cephalic arch stenosis: Rationale and design of arch V SUPERA-LUX Study. J Vasc Access. 2020 Jul;21(4):504-510. doi: 10.1177/1129729819881589. Epub 2019 Oct 17.
- Individual participant dataSharing planned: No
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
Singapore General 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 Passeo-18 Lux and SUPERA® stent in people with Brachiocephalic Vein Stenosis, 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 5 inclusion and 25 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: finished, as of the sponsor's last update on 17 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Angiographic Success (time frame: Immediately post-operation). The study lists 3 primary outcomes in all. 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 NCT03891693, which also lists 8 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 17 Mar 2021.