Arch-V: Biomimetic Stent and Drug Eluting Balloon to Treat Recurrent Cephalic Arch Stenosis
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Passeo-18 Lux and SUPERA® stent Target lesion will be treated with Passeo-18 Lux Drug Eluting Balloon and SUPERA® stent during angioplasty |
Device: Passeo-18 Lux and SUPERA® stent
Angioplasty of Arteriovenous Fistula (AVF) performed using Passeo-18 Lux and SUPERA® stent for patients with cephalic arch stenosis
|
Outcome Measures
Primary Outcome Measures
- Angiographic Success [Immediately post-operation]
<30% regional stenosis within the stent and minimal lumen size should reach 5mm
- Functional Fistula [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 [1 year post-operation]
Less than 50% stenosis observed on duplex ultrasound
Secondary Outcome Measures
- Access Circuit Thrombosis [1 year post-operation]
Thrombosis of access circuit requiring further intervention such as thrombolysis
- Number of re-interventions per year [1 year post-operation]
To note any re-interventions performed post-study procedure
- Access Circuit Restenosis / Stent Fractures [1 year post-operation]
To note any restenosis or stent fractures during study period that requires re-intervention
- Access Circuit Infection [1 year post-operation]
To note any infection at treated fistula during study period
- Need for bypass revision surgery [1 year post-operation]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patient's age is above 21 and below 90
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Informed consent obtained
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Chronic background treatment with daily ASA
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Patients with significant Cephalic Arch Vein Stenosis or recurrent stenosis within 6 months of initial POBA diagnosed either clinically or with Duplex Ultrasound
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Post-angioplasty cephalic arch lumen size between 5mm - 7mm maximum diameter
Exclusion Criteria:
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Patients with significant central vein stenosis (>70%) or total occlusion at time of angiographic study
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Cephalic arch stenosis <50% stenosis or diameter >5mm
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Patients with previous cephalic arch stenting (Bare Metal Stents or stent graft)
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Concomitant fistula inflow problem (e.g. juxta-anastomotic) that cannot be corrected optimally during the intervention (>30% residual stenosis or angiographic lumen <3mm)
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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
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Cephalic arch lesion length <10mm or greater than 10cm
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Patients with uncontrolled hypertension
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Patient <21 or > 90 years of age.
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Pregnant women or women of childbearing potential who are not following an effective method of contraception.
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Contraindication to aspirin or clopidogrel usage
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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.
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Uncooperative attitude or potential for non-compliance with the requirements of the protocol making study participation impractical
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Patients who do NOT have impaired renal function
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Occluded or thrombosed fistula
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Patients presenting with central venous stenosis
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Final angioplasty treatment requires a stent or DEB >7mm in diameter
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Multiple lesions in the access circuit that cannot be treated with one stent and DEB.
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Vascular access circuit placed in the lower extremities
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Bare metal stent or stent-graft placed previously
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Metastatic caner or terminal medical condition
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Blood coagulation disorder
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Limited life expectancy (<6 months)
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Sepsis or active infection
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Recent arm thrombophlebitis
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Allergy or other known contraindication to iodinated media contrast, heparin or paclitaxel
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Singapore General Hospital | Singapore | Singapore | 169608 |
Sponsors and Collaborators
- Singapore General Hospital
Investigators
- Principal Investigator: Tang Tjun Yip, Singapore General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Bishu 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. Review.
- Cho 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.
- Garcia 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). pii: e000937. doi: 10.1161/CIRCINTERVENTIONS.113.000937. Erratum in: Circ Cardiovasc Interv. 2015 Jun;8(6). pii: e000014. doi: 10.1161/HCV.0000000000000014.
- Micari 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.
- Scheinert D, Werner M, Scheinert S, Paetzold A, Banning-Eichenseer U, Piorkowski M, Ulrich M, Bausback Y, Bräunlich 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.
- Zeller 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.
- Zhang 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. Review.
- 2018/2557