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

Primary Purpose

Brachiocephalic Vein Stenosis

Status

Completed

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Passeo-18 Lux and SUPERA® stent

About this trial

This is an interventional treatment trial for Brachiocephalic Vein Stenosis focused on measuring Stenosis, Angioplasty, Vascular Disease

Eligibility Criteria

21 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Singapore General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Passeo-18 Lux and SUPERA® stent

Arm Description

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

Outcomes

Primary Outcome Measures

Angiographic Success

<30% regional stenosis within the stent and minimal lumen size should reach 5mm

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.

Primary Patency of Cephalic Arch

Less than 50% stenosis observed on duplex ultrasound

Secondary Outcome Measures

Access Circuit Thrombosis

Thrombosis of access circuit requiring further intervention such as thrombolysis

Number of re-interventions per year

To note any re-interventions performed post-study procedure

Access Circuit Restenosis / Stent Fractures

To note any restenosis or stent fractures during study period that requires re-intervention

Access Circuit Infection

To note any infection at treated fistula during study period

Need for bypass revision surgery

Full Information

NCT ID

NCT03891693

First Posted

March 4, 2019

Last Updated

March 16, 2021

Sponsor

Singapore General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03891693

Brief Title

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

Acronym

Arch-V

Official Title

Biomimetic (SUPERA) Stent and Drug Eluting Balloon (Passeo 18 Lux) to Treat Recurrent Cephalic Arch Stenosis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

September 5, 2018 (Actual)

Primary Completion Date

June 30, 2020 (Actual)

Study Completion Date

January 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Singapore General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brachiocephalic Vein Stenosis

Keywords

Stenosis, Angioplasty, Vascular Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

All subjects will be treated with SUPERA® stents and Passeo-18-Lux

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Passeo-18 Lux and SUPERA® stent

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Passeo-18 Lux and SUPERA® stent

Intervention Description

Angioplasty of Arteriovenous Fistula (AVF) performed using Passeo-18 Lux and SUPERA® stent for patients with cephalic arch stenosis

Primary Outcome Measure Information:

Title

Angiographic Success

Description

<30% regional stenosis within the stent and minimal lumen size should reach 5mm

Time Frame

Immediately post-operation

Title

Functional Fistula

Description

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.

Time Frame

Post-operation 1 week, 2 months, 6 months and 12 months.

Title

Primary Patency of Cephalic Arch

Description

Less than 50% stenosis observed on duplex ultrasound

Time Frame

1 year post-operation

Secondary Outcome Measure Information:

Title

Access Circuit Thrombosis

Description

Thrombosis of access circuit requiring further intervention such as thrombolysis

Time Frame

1 year post-operation

Title

Number of re-interventions per year

Description

To note any re-interventions performed post-study procedure

Time Frame

1 year post-operation

Title

Access Circuit Restenosis / Stent Fractures

Description

To note any restenosis or stent fractures during study period that requires re-intervention

Time Frame

1 year post-operation

Title

Access Circuit Infection

Description

To note any infection at treated fistula during study period

Time Frame

1 year post-operation

Title

Need for bypass revision surgery

Time Frame

1 year post-operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tang Tjun Yip

Organizational Affiliation

Singapore General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Singapore General Hospital

City

Singapore

ZIP/Postal Code

169608

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23347863

Citation

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Results Reference

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Citation

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Citation

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Citation

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Citation

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Results Reference

derived

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

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