NCT03891693|Completed
Biomimetic Stent and Drug Eluting Balloon to Treat Recurrent Cephalic Arch Stenosis
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Biomimetic (SUPERA) Stent and Drug Eluting Balloon (Passeo 18 Lux) to Treat Recurrent Cephalic Arch Stenosis
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Biomimetic (SUPERA) Stent and Drug Eluting Balloon (Passeo 18 Lux) to Treat Recurrent Cephalic Arch Stenosis
Sponsor study identifier
interventional
20
1 country
1
Study Start
September 5, 2018
Actual (reported)Primary Completion
June 30, 2020
Actual (reported)Study Completion
January 30, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 30, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 5, 2018
Actual (reported)March 4, 2019
Actual (reported)March 27, 2019
Actual (reported)June 30, 2020
Actual (reported)January 30, 2021
Actual (reported)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
Access Circuit Thrombosis
1 year post-operation
Number of re-interventions per year
1 year post-operation
Access Circuit Restenosis / Stent Fractures
1 year post-operation
Access Circuit Infection
1 year post-operation
Need for bypass revision surgery
1 year post-operation
Target lesion will be treated with Passeo-18 Lux Drug Eluting Balloon and SUPERA® stent during angioplasty
Angioplasty of Arteriovenous Fistula (AVF) performed using Passeo-18 Lux and SUPERA® stent for patients with cephalic arch stenosis
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Singapore General Hospital
Singapore, 169608, Singapore
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.
Tang Tjun Yip
Singapore General Hospital
20 participants (actual enrollment reported by the registry).
First Submitted
March 4, 2019
First Posted
March 27, 2019
Study Start
September 5, 2018
Actual (reported)Contact the study team to confirm eligibility.
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.
Primary Completion
June 30, 2020
Actual (reported)Study Completion
January 30, 2021
Actual (reported)Last Updated
March 17, 2021
Record last verified: 2021-03
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