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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03891693
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : March 18, 2020
Information provided by (Responsible Party):
Singapore General Hospital

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
Brachiocephalic Vein Stenosis Device: Passeo-18 Lux and SUPERA® stent Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: All subjects will be treated with SUPERA® stents and Passeo-18-Lux
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biomimetic (SUPERA) Stent and Drug Eluting Balloon (Passeo 18 Lux) to Treat Recurrent Cephalic Arch Stenosis
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty Fistulas

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

Primary Outcome Measures :
  1. Angiographic Success [ Time Frame: Immediately post-operation ]
    <30% regional stenosis within the stent and minimal lumen size should reach 5mm

  2. 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.

  3. Primary Patency of Cephalic Arch [ Time Frame: 1 year post-operation ]
    Less than 50% stenosis observed on duplex ultrasound

Secondary Outcome Measures :
  1. Access Circuit Thrombosis [ Time Frame: 1 year post-operation ]
    Thrombosis of access circuit requiring further intervention such as thrombolysis

  2. Number of re-interventions per year [ Time Frame: 1 year post-operation ]
    To note any re-interventions performed post-study procedure

  3. Access Circuit Restenosis / Stent Fractures [ Time Frame: 1 year post-operation ]
    To note any restenosis or stent fractures during study period that requires re-intervention

  4. Access Circuit Infection [ Time Frame: 1 year post-operation ]
    To note any infection at treated fistula during study period

  5. Need for bypass revision surgery [ Time Frame: 1 year post-operation ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03891693

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Contact: Charyl Yap 6576 7986

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Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Charyl Yap    65767986   
Sponsors and Collaborators
Singapore General Hospital
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Principal Investigator: Tang Tjun Yip Singapore General Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Singapore General Hospital Identifier: NCT03891693    
Other Study ID Numbers: 2018/2557
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Singapore General Hospital:
Vascular Disease
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical