Biomimetic Stent and Drug Eluting Balloon to Treat Recurrent Cephalic Arch Stenosis

Not Applicable

Completed

• Conditions: Brachiocephalic Vein Stenosis
• Interventions: Device: Passeo-18 Lux and SUPERA® stent

• Registration Number: NCT03891693
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-09-05
• Study First Submitted: 2019-03-04
• Study First Submitted QC: 2019-03-25
• Study First Posted: 2019-03-27
• Primary Completion: 2020-06-30
• Study Completion: 2021-01-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Passeo-18 Lux and SUPERA® stent	Passeo-18 Lux and SUPERA® stent	Target lesion will be treated with Passeo-18 Lux Drug Eluting Balloon and SUPERA® stent during angioplasty

Primary Outcome Measures

Name	Time	Method
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.
Angiographic Success	Immediately post-operation	\<30% regional stenosis within the stent and minimal lumen size should reach 5mm
Primary Patency of Cephalic Arch	1 year post-operation	Less than 50% stenosis observed on duplex ultrasound

Secondary Outcome Measures

Name	Time	Method
Access Circuit Thrombosis	1 year post-operation	Thrombosis of access circuit requiring further intervention such as thrombolysis
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
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

Trial Locations

Locations (1)

Singapore General Hospital; 🇸🇬 Singapore, Singapore