Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000071729
Ethics application status
Approved
Date submitted
23/11/2021
Date registered
21/01/2022
Date last updated
14/11/2024
Date data sharing statement initially provided
21/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
First in Human Early Feasibility study of BD(TM) Sirolimus Drug Coated Balloon Catheter for Treatment of Femoropopliteal Arteries
Scientific title
A Prospective, Multicenter, Single Arm, Non-Randomized, Study to Assess the Performance and Safety of BD (TM) Sirolimus Drug Coated Balloon Catheter for Treatment of Femoropopliteal Arteries
Secondary ID [1] 305840 0
BDPI-20-012
Secondary ID [2] 313383 0
NCT05556681
Universal Trial Number (UTN)
Trial acronym
PREVISION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Artery Disease 324380 0
Femoropopliteal lesions 324381 0
Superficial Femoral Artery lesions 324382 0
Condition category
Condition code
Cardiovascular 321866 321866 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The BD (TM) Sirolimus Drug Coated Balloon Catheter consists of an over-the-wire (OTW) percutaneous transluminal angioplasty balloon catheter coated with sirolimus on the surface of the balloon. The procedure will use angiogram imaging while a interventional radiologist or vascular surgeon delivers the investigational device. This procedure is expected to take approximately 60 minutes. This is a one time intervention during participation of this clinical trial. In order to evaluate the success of this intervention, angiogram imaging will be done at six month follow up visit. this adherence is considered outside of normal standard of care operations.
Intervention code [1] 322243 0
Treatment: Devices
Comparator / control treatment
No Control group - Single arm study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329622 0
Late Lumen Loss (LLL) of the target lesion, as measured by Quantitative Vascular Angiography (QVA) at 6 Months
Timepoint [1] 329622 0
6 months post interventional angioplasty with the BD(TM) Sirolimus Drug Coated Balloon.
Secondary outcome [1] 403201 0
Evaluation of Primary Patency changes via duplex ultrasound.
Timepoint [1] 403201 0
6-months, 12-months, and 24-months post index procedure
Secondary outcome [2] 441748 0
Freedom from embolization, including all thromboembolization events, reported by the participating study sites.
Timepoint [2] 441748 0
Secondary outcome [3] 441749 0
Freedom from embolization, including all thromboembolization events, reported by the participating study sites.
Timepoint [3] 441749 0
6-months, 12-months, and 24-months post index procedure
Secondary outcome [4] 441750 0
Rate of all-cause death reported by the participating study sites.
Timepoint [4] 441750 0
6-months, 12-months, and 24-months post index procedure
Secondary outcome [5] 441751 0
Rate of all-cause death reported by the participating study sites.
Timepoint [5] 441751 0
6-months, 12-months, and 24-months post index procedure
Secondary outcome [6] 441752 0
Rate of major adverse cardiovascular events (MACE) reported by the participating study sites.
Timepoint [6] 441752 0
6-months, 12-months, and 24-months post index procedure
Secondary outcome [7] 441753 0
Rate of major adverse cardiovascular events (MACE) reported by the participating study sites.
Timepoint [7] 441753 0
30-days, 6-months, 12-months, and 24-months post index procedure
Secondary outcome [8] 441754 0
Safety composite including freedom from device- and procedure-related death and freedom from major target limb amputation (above the ankle), reported by the participating study sites.
Timepoint [8] 441754 0
30-days, 6-months, 12-months, and 24-months post index procedure
Secondary outcome [9] 441755 0
Safety composite including freedom from device- and procedure-related death and freedom from major target limb amputation (above the ankle), reported by the participating study sites.
Timepoint [9] 441755 0
Device- and procedure-related death through 30-days, and freedom from major target limb amputation (above the ankle) through 6-months, 12-months, and 24-months post index procedure.
Secondary outcome [10] 441756 0
Composite of technical and procedural success rates, reported by the participating site investigator.
Timepoint [10] 441756 0
Device- and procedure-related death through 30-days, and freedom from major target limb amputation (above the ankle) through 6-months, 12-months, and 24-months post index procedure.
Secondary outcome [11] 441757 0
Composite of technical and procedural success rates, reported by the participating site investigator.
Timepoint [11] 441757 0
At completion of index procedure.
Secondary outcome [12] 441758 0
Change in Rutherford Classification assessed by the participating site investigator.
Timepoint [12] 441758 0
At completion of index procedure.
Secondary outcome [13] 441759 0
Change in Rutherford Classification assessed by the participating site investigator.
Timepoint [13] 441759 0
6-months, 12-months, and 24-months post index procedure
Secondary outcome [14] 441760 0
Rate of Clinically Driven Target Lesion Revascularization (CD-TLR) determined by an independent core laboratory.
Timepoint [14] 441760 0
6-months, 12-months, and 24-months post index procedure
Secondary outcome [15] 441761 0
Rate of Clinically Driven Target Lesion Revascularization (CD-TLR) determined by an independent core laboratory.
Timepoint [15] 441761 0
6-months, 12-months, and 24-months post index procedure
Secondary outcome [16] 441762 0
Change in Ankle-Brachial Index (ABI).
Timepoint [16] 441762 0
6-months, 12-months, and 24-months post index procedure
Secondary outcome [17] 441763 0
Change in Ankle-Brachial Index (ABI).
Timepoint [17] 441763 0
6-months, 12-months, and 24-months post index procedure
Secondary outcome [18] 441764 0
Changes in Patient Reported Outcome (PRO) via EuroQol 5 Dimension Quality of Life Questionnaire (EQ-5D-5L).
Timepoint [18] 441764 0
6-months, 12-months, and 24-months post index procedure
Secondary outcome [19] 441765 0
Changes in Patient Reported Outcome (PRO) via EuroQol 5 Dimension Quality of Life Questionnaire (EQ-5D-5L).
Timepoint [19] 441765 0
6-months, 12-months, and 24-months post index procedure
Secondary outcome [20] 441766 0
Rate of Clinically Driven Target Vessel Revascularization (CD-TVR) determined by an independent core laboratory.
Timepoint [20] 441766 0
6-months, 12-months, and 24-months post index procedure
Secondary outcome [21] 441767 0
Rate of Clinically Driven Target Vessel Revascularization (CD-TVR) determined by an independent core laboratory.
Timepoint [21] 441767 0
6-months, 12-months, and 24-months post index procedure
Secondary outcome [22] 441768 0
Changes in Patient Reported Outcome (PRO) via Walking Impairment Questionnaire (WIQ).
Timepoint [22] 441768 0
6-months, 12-months, and 24-months post index procedure
Secondary outcome [23] 441769 0
Changes in Patient Reported Outcome (PRO) via Walking Impairment Questionnaire (WIQ).
Timepoint [23] 441769 0
6-months, 12-months, and 24-months post index procedure

Eligibility
Key inclusion criteria
Greater than or equal to 18 years of age
Rutherford Clinical Category 2-4
Lesion greater than or equal to 70% stenosis by visual estimate
Lesion Length greater than or equal to 3 cm and less than or equal to 17 cm
Target reference vessel diameter of 5-6 mm and able to be treated with available device size matrix
Minimum age
18 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Less than or equal to 90 years of age
Life expectancy of less than 2 years
Participant has acute limb ischemia
Severe Calcification as defined as PARC scoring system
Participant is currently participating in an investigational drug or device study, or previously enrolled in a trial within the last 30 days prior to screening.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
28/03/2022
Actual
2/08/2022
Date of last participant enrolment
Anticipated
30/09/2022
Actual
8/12/2023
Date of last data collection
Anticipated
8/12/2025
Actual
Sample size
Target
50
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment outside Australia
Country [1] 24342 0
New Zealand
State/province [1] 24342 0
Country [2] 26729 0
Singapore
State/province [2] 26729 0

Funding & Sponsors
Funding source category [1] 310198 0
Commercial sector/Industry
Name [1] 310198 0
Becton, Dickinson and Company (BD)
Country [1] 310198 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Becton, Dickinson and Company (BD)
Address
BD Australia Head Office
BD
Level 5
66 Waterloo Road
Macquarie Park
NSW, 2113
Country
Australia
Secondary sponsor category [1] 311286 0
None
Name [1] 311286 0
Address [1] 311286 0
Country [1] 311286 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309877 0
Bellberry Human Research Ethics Committee E
Ethics committee address [1] 309877 0
Ethics committee country [1] 309877 0
Australia
Date submitted for ethics approval [1] 309877 0
07/12/2021
Approval date [1] 309877 0
31/05/2022
Ethics approval number [1] 309877 0
Ethics committee name [2] 316510 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [2] 316510 0
Ethics committee country [2] 316510 0
Australia
Date submitted for ethics approval [2] 316510 0
22/02/2022
Approval date [2] 316510 0
07/06/2022
Ethics approval number [2] 316510 0
Ethics committee name [3] 316511 0
Southern Health and Disability Ethics Committee
Ethics committee address [3] 316511 0
Ethics committee country [3] 316511 0
New Zealand
Date submitted for ethics approval [3] 316511 0
31/03/2022
Approval date [3] 316511 0
28/04/2022
Ethics approval number [3] 316511 0
Ethics committee name [4] 316512 0
National Healthcare Group (NHG) Domain Specific Review Board C
Ethics committee address [4] 316512 0
Ethics committee country [4] 316512 0
Singapore
Date submitted for ethics approval [4] 316512 0
21/04/2023
Approval date [4] 316512 0
28/04/2023
Ethics approval number [4] 316512 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115702 0
Prof Andrew Holden
Address 115702 0
Vascular Interventional Research Unit, Vascular Service, Level 4, Building 32, Park Road, Grafton, Auckland, New Zealand 1023
Country 115702 0
New Zealand
Phone 115702 0
+64 9 307 4949
Fax 115702 0
Email 115702 0
andrewh@adhb.govt.nz
Contact person for public queries
Name 115703 0
Bethany Cross
Address 115703 0
BD
850 West Rio Salado Parkway
Tempe, AZ
85281
Country 115703 0
United States of America
Phone 115703 0
+1 9703424253
Fax 115703 0
Email 115703 0
bethany.cross@bd.com
Contact person for scientific queries
Name 115704 0
Talar Saber
Address 115704 0
BD
850 West Rio Salado Parkway
Tempe, AZ
85281
Country 115704 0
United States of America
Phone 115704 0
+1 4808480772
Fax 115704 0
Email 115704 0
Talar.Saber@bd.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.