Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00544

2 Trial Registration Date

2017-01-06

i Registration Status

Prospective

3 Secondary IDs

KW/FR-16-166(104-03)

4 Source(s) of Funding

N/A

5 Primary Sponsor

N/A

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Dr. Luk Wing-hang

ii Address

Princess Margaret Hospital
2-10, Princess Margaret Hospital Road, Lai Chi Kok, Kowloon, Hong Kong

iii Phone

29902717

iv Email

lukwinghang@gmail.com

v Affiliation

Consultant, Diagnostic Radiology Department, Princess Margaret Hospital

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Wing-hang Luk

ii Address

Princess Margaret Hospital
2-10, Princess Margaret Hospital Road, Lai Chi Kok, Kowloon, Hong Kong

iii Phone

29902717

iv Email

lukwinghang@gmail.com

v Affiliation

Diagnostic Radiology Department, Princess Margaret Hospital

vi Country

Hong Kong

9 Official Scientific Title of the Study

Randomized Clinical Trial of Angiosculpt Balloon Angioplasty versus Conventional Balloon Angioplasty in Hemodialysis Arteriovenous Fistula Stenoses

10 Public Title

Randomized Clinical Trial of Angiosculpt Balloon Angioplasty versus Conventional Balloon Angioplasty in Hemodialysis Arteriovenous Fistula Stenoses

i Public Title in Chinese 研究名稱

比較折疊球囊導管血管成形術與傳統球囊導管血管成形術的隨機臨床試驗

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2016-11-17

iii Full Name of IRB/IEC

Kowloon West Cluster Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

KW/FR-16-166(104-03)

14 Medical Condition Being Studied

Hemodialysis Arteriovenous Fistula Stenoses

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

Balloon angioplasty with AngioSculpt PTA balloon catheter

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

N/A

v Duration of the intervention

N/A

vi Frequency of the intervention

N/A

16 Comparative Treatments

i Description/ name of comparative treatments

Balloon angioplasty with conventional balloon catheter

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Percutaneous Transluminal Angioplasty will performed in end-stage renal failure patients with hemodynamically significant (defined as >50%) stenosis of the autogenous fistula.

ii Exclusion Criteria

- Patient refusing treatment

- The reference segment diameter is not suitable for available catheter design

- Previous PTA for the same lesion

- Associated significant (>50%) central venous stenosis

- Multiple significant (>50%) stenosis

- The patient is minor (<18 years old)

- Previous access thrombectomy

- Positive pregnancy test result within 7 days before enrolment

- Patient is scheduled for a kidney transplant

- Life expectancy <6 months

- The patient has a known allergy to heparin, aspirin or other anticoagulant/ antiplatelet therapies

- The patient is currently enrolled in another investigational device or drug trial

- The patient is currently breast-feeding, pregnant or intends to become pregnant

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

60 patients randomized into 2 groups, 30 in experimental group, 30 in control group

ii Nature of control

Active

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Other

Please specify

Commercial available product

vi Study Objectives (Optional)

The primary objective is to evaluate at post-operation, 1 month, 6 months and 12 months follow-ups the safety and efficacy of scoring balloon for AV Fistula based on primary patency of target lesions in experimental and control groups.

20 Anticipated trial start date

2017-01-18

21 Target Sample Size

60

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Patency of the target lesion of control and experimental groups

ii The metric or method of measurement used

Clinical examination, dialysis access venous pressure measurement during dialysis and measurements of dialysis access recirculation

iii The timepoint(s) of primary interest

1, 6 and 12 months

24 Secondary Outcome

i The Name of the outcome

Immediate angiographic scoring success, defined as residual diameter stenosis smaller than 30% and absence of flow-limiting dissection on visual assessment after scoring balloon treatment

ii The metric or method of measurement used

Clinical examination

iii The timepoint(s) of primary interest

Post intervention

Secondary Outcome

i The Name of the outcome

Hemodialysis success, defined as restoration of normal blood flow through the treated vascular lesion

ii The metric or method of measurement used

Clinical examination, dialysis access venous pressure measurement during dialysis and measurements of dialysis access recirculation

iii The timepoint(s) of primary interest

1, 6 and 12 months

Secondary Outcome

i The Name of the outcome

Peri-procedural complications (less than 24 hours) will be evaluated including death, stroke, myocardial infarction of the scoring balloon treated lesion, significant distal embolization in the target limb and thrombosis of target limb.

ii The metric or method of measurement used

Clinical examination

iii The timepoint(s) of primary interest

Post intervention - 24 hours

Secondary Outcome

i The Name of the outcome

Complications at 30 days including death, stroke, myocardial infarction, emergent percutaneous or surgical revascularization of the scoring balloon treated lesion, significant distal embolization in the target limb and thrombosis of target limb.

ii The metric or method of measurement used

Clinical examination

iii The timepoint(s) of primary interest

Post intervention - 30 days

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-01-16

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2017-01-06