Biomimetic Stent and Drug Eluting Balloon to Treat Recurrent Cephalic Arch Stenosis (Arch-V)

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.

Study Overview

• Status: Completed
• Conditions: Brachiocephalic Vein Stenosis
• Intervention / Treatment: Device: Passeo-18 Lux and SUPERA® stent

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiographic Success	<30% regional stenosis within the stent and minimal lumen size should reach 5mm	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.	Post-operation 1 week, 2 months, 6 months and 12 months.
Primary Patency of Cephalic Arch	Less than 50% stenosis observed on duplex ultrasound	1 year post-operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Access Circuit Thrombosis	Thrombosis of access circuit requiring further intervention such as thrombolysis	1 year post-operation
Number of re-interventions per year	To note any re-interventions performed post-study procedure	1 year post-operation
Access Circuit Restenosis / Stent Fractures	To note any restenosis or stent fractures during study period that requires re-intervention	1 year post-operation
Access Circuit Infection	To note any infection at treated fistula during study period	1 year post-operation
Need for bypass revision surgery		1 year post-operation

Collaborators and Investigators

• Sponsor: Singapore General Hospital
• Investigators: Principal Investigator: Tang Tjun Yip, Singapore General Hospital

Publications and helpful links

General 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.
• 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):e000937. doi: 10.1161/CIRCINTERVENTIONS.113.000937. Erratum In: Circ Cardiovasc Interv. 2015 Jun;8(6). pii: e000014. doi: 10.1161/HCV.0000000000000014.
• 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.
• 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.
• 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.
• 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.
• Tang 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2018
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): January 30, 2021

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 27, 2019

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Vascular Disease; Stenosis; Angioplasty
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: 2018/2557

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No