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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05556681




Registration number
NCT05556681
Ethics application status
Date submitted
12/09/2022
Date registered
27/09/2022
Date last updated
30/01/2024

Titles & IDs
Public title
Study of BD Sirolimus Drug Coated Catheter for Treatment of Femoropopliteal Arteries
Scientific title
Prospective, Multicenter, Single Arm, Non-Randomized Study of BD Sirolimus Drug Coated Catheter for Treatment of Femoropopliteal Arteries
Secondary ID [1] 0 0
BDPI-20-012
Universal Trial Number (UTN)
Trial acronym
PREVISION
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Peripheral Artery Disease 0 0
Stenosis Artery 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - BD™ Sirolimus Drug Coated Balloon Catheter angioplasty

Treated with the investigational BD™ Sirolimus Drug Coated Catheter - Patients treated with the BD™ Sirolimus Drug Coated Catheter


Treatment: Devices: BD™ Sirolimus Drug Coated Balloon Catheter angioplasty
The study will enroll patients presenting with clinical evidence of an angiographically significant lesion (Lesion = 70% stenosis by visual estimate) in the femoropopliteal arteries. After pre-dilatation, patients will undergo angioplasty with the investigational BD™ Sirolimus Drug Coated Balloon Catheter.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Late lumen loss at six months as measured by quantitative vascular angiography (QVA).
Timepoint [1] 0 0
at 6 month follow-up
Secondary outcome [1] 0 0
Rutherford Improvement
Timepoint [1] 0 0
at discharge, and 1, 6, 12 and 24 month follow-up
Secondary outcome [2] 0 0
Patient Reported Outcome Improvement
Timepoint [2] 0 0
at post-procedure, and 1, 6, 12 and 24 month follow-up
Secondary outcome [3] 0 0
Freedom of Embolization
Timepoint [3] 0 0
at discharge, and 1, 6, 12 and 24 month follow-up
Secondary outcome [4] 0 0
ABI Improvement
Timepoint [4] 0 0
at discharge, and 1, 6, 12 and 24 month follow-up
Secondary outcome [5] 0 0
Revascularization rate (CD-TLR)
Timepoint [5] 0 0
at discharge, and 1, 6, 12 and 24 month follow-up
Secondary outcome [6] 0 0
Technical & Procedural Success statistical analyses associated with them but will be reported upon in the final study report.
Timepoint [6] 0 0
at discharge, and 1, 6, 12 and 24 month follow-up
Secondary outcome [7] 0 0
All Cause Death statistical analyses associated with them but will be reported upon in the final study report.
Timepoint [7] 0 0
at discharge, and 1, 6, 12 and 24 month follow-up
Secondary outcome [8] 0 0
Major Adverse Cardiovascular Events (MACE) statistical analyses associated with them but will be reported upon in the final study report.
Timepoint [8] 0 0
at discharge, and 1, 6, 12 and 24 month follow-up
Secondary outcome [9] 0 0
Safety Composite statistical analyses associated with them but will be reported upon in the final study report.
Timepoint [9] 0 0
at discharge, and 1, 6, 12 and 24 month follow-up

Eligibility
Key inclusion criteria
Pre-Operative

1. =18 years of age

2. Rutherford Clinical Category 2-4

3. Patient is willing to provide informed consent, is geographically stable, comply with
the required follow up visits, testing schedule, and recommended medication regimen

4. Women of childbearing potential who have a negative urine pregnancy test (UPT) at
screening

Angiographical

1. One Lesion of = 3 cm and = 17 cm in length (if two discrete lesions are separated by =
3 cm, but both falling within a composite length of = 17 cm, they may be treated as
one lesion).

2. Lesion =70% stenosis by visual estimate

3. Lesion location starts =1 cm below the common femoral bifurcation and terminates
distally =2 cm above the tibial plateau.

4. De novo or non-stented restenotic lesion(s) in native femoropopliteal arteries >90
days from prior interventional procedure

5. Lesion is located at least 3 cm from any stent

6. Target reference vessel diameter of 5-6 mm and able to be treated with available
device size matrix

7. Successful, uncomplicated (without use of crossing device, specialty 035 guidewire are
acceptable) antegrade wire crossing of lesion

8. Successful vessel preparation of the target lesion. Successful vessel preparation is
defined by successful pre-dilatation to nominal of the target lesion, in the absence
of early recoil, significant residual stenosis =30% as confirmed by angiography
without any major vascular complications or flow-limiting dissections.

9. A patent inflow artery free from significant lesion stenosis (=50% stenosis) as
confirmed by standard of care imaging and the discretion of the investigator. Only
treatment of ipsilateral iliac inflow arteries is acceptable before the treatment of
the target lesion, defined as attainment of residual diameter stenosis =30% without
death or major vascular complication

10. At least one patent native outflow artery to the ankle, free from significant (=50%)
stenosis as confirmed by angiography, that has not previously been revascularized
(outflow to be assessed after successful vessel preparation of target lesion;
treatment of outflow disease is NOT permitted during the index procedure)
Minimum age
18 Years
Maximum age
89 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pre-Operative

1. = 90 years of age

2. Women who are breastfeeding, currently pregnant or planning to become pregnant during
the duration of the study or have a positive urine pregnancy test at screening. Men
who are intending to biologically father children during the duration of the study

3. Life expectancy of <2 years

4. Participant has acute limb ischemia

5. Previous treatment of the target limb using Drug Coated Balloon (DCB), a stent, or
Drug Eluting Stent (DES) within the last 180 days.

6. Previous treatment of the contralateral limb using Drug Coated Balloon (DCB) or Drug
Eluting Stent (DES) within the last 90 days.

7. History of stroke or Transient Ischemic Attack (TIA) within 90 days.

8. History of myocardial infarction (MI), thrombolysis or angina within 30 days of index
procedure

9. Renal failure (on dialysis) or chronic kidney disease (Glomerular Filtration Rate
(GFR) < 30 ml/min per 1.73m2 (or serum creatinine =2.5 mg/L within 30 days of index
procedure or treated with dialysis)) that in the opinion of the investigator should
preclude participant enrollment in the study

10. Active or suspected active infection at time of index procedure that in the opinion of
the investigator should preclude participant enrollment in the study

11. Patients with any type of previous or planned surgical or interventional procedure
within 30 days prior and/or within 30 days post-index procedure

12. Sudden symptom onset (within two weeks), acute vessel occlusion, or acute or sub-acute
thrombus in target vessel or history of treatment of thrombolysis in the target legion

13. Known contraindication (including allergic reaction) or sensitivity to sirolimus
(rapamycin).

14. Known contraindication (including reaction) or sensitivity to iodinated contrast
media, that cannot be adequately managed with pre- and post-procedure medication. CO2
angiography is not allowed.

15. Has received systemic immunosuppressants or immunemodifying drugs for >14 days in
total within 3 months prior to Screening (for corticosteroids = 20 mg/day of
prednisone equivalent, excluding standard of care use of inhaled corticosteroids).

16. Immunosuppressive or immunodeficient state, in the opinion of the investigator, that
would preclude the participant from being eligible to be treated with a sirolimus DCB.
Note: HIV positive participants with CD4 count =350 cells/mm3 and an undetectable HIV
viral load within the past year [low level variations from 50-500 viral copies which
do not lead to changes in antiretroviral therapy [ART] are permitted.

17. Has active malignancy prior to study entry

18. Bleeding diathesis, Gastrointestinal ulceration, another coagulopathy disorder, or
allergy in the opinion of the investigator, which would restrict the use of
anticoagulant or dual antiplatelet therapy (DAPT)

19. 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. Enrollment
in another investigational drug or device study during the follow up period for this
study is not allowed.

20. Current alcohol or drug abuse that in the opinion of the investigator should preclude
participant enrollment in the study

21. Participant has a condition that in the opinion of the investigator should preclude
participant enrollment in the study

Angiographical

1. Severe Calcification as defined as PARC scoring system (> 180 degrees (both sides of
the vessel at the same location) and greater than one-half of the total lesion length)
of the target lesion.

2. Intended use of adjunctive primary treatment modalities (e.g., atherectomy, laser,
cutting balloons, radiation therapy, stents, other drug coated devices.)

3. Use of reentry devices during the index procedure for antegrade recanalization, which
include but are not limited to percutaneous intentional extraluminal recanalization
(PIER) and subintimal arterial flossing with antegrade retrograde intervention
(SAFARI) techniques.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2025
Actual
Sample size
Target
Accrual to date
Final
34
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 0 0
Gold Coast University Hospital - Southport
Recruitment hospital [4] 0 0
Flinders University - Adelaide
Recruitment hospital [5] 0 0
The Alfred - Melbourne
Recruitment hospital [6] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
5001 - Adelaide
Recruitment postcode(s) [5] 0 0
3004 - Melbourne
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Waikato
Country [3] 0 0
Singapore
State/province [3] 0 0
Novena
Country [4] 0 0
Singapore
State/province [4] 0 0
Punggol

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
C. R. Bard
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this early feasibility study is to assess the safety and performance of the
BD™ Sirolimus Drug Coated Balloon Catheter.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05556681
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries