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Peripheral Arterial DiseasePREVISIONNCT05556681

Study of BD Sirolimus Drug Coated Catheter for Treatment of Femoropopliteal Arteries

A study testing BD™ Sirolimus Drug Coated Balloon Catheter percutaneous transluminal angioplasty in people with Peripheral Arterial Disease and Peripheral Artery Disease, run by C. R. Bard at 10 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The objective of this early feasibility study is to assess the safety and performance of the BD™ Sirolimus Drug Coated Balloon Catheter. Read more about this study

Who is it for?
Ages 18 to 89 years
What is being tested?
BD™ Sirolimus Drug Coated Balloon Catheter percutaneous transluminal angioplasty
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
10 sitesin 3 countries
Study dates
2 Aug 2022to 24 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pre-Operative Inclusion Criteria:
  • ≥18 years of age.
  • Rutherford Clinical Category 2-4.
  • Participant is willing to provide informed consent, is geographically stable, comply with the required follow up visits and testing schedule and recommended medication regimen.
  • Women of childbearing potential who have a negative UPT at screening.
  • Angiographical Inclusion Criteria:
Show all 17Show fewer
  • 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).
  • Lesion ≥70% stenosis by visual estimate.
  • Lesion location starts ≥1 cm below the common femoral bifurcation and terminates above the distal P2 segment (top of the tibial plateau).
  • De novo or non-stented restenotic lesion(s) in native femoropopliteal arteries >90 days from prior interventional procedure.
  • Lesion is located at least 3 cm from any stent.
  • Target reference vessel diameter of 5-6 mm and able to be treated with available device size matrix.
  • Successful, uncomplicated (without use of crossing device, specialty 035 guidewires are acceptable) antegrade wire crossing of lesion.
  • 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.
  • 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.
  • 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).
  • 1. Participant must meet all main study inclusion and exclusion criteria.

Who cannot join

  • Pre-Operative Exclusion Criteria:
  • ≥ 90 years of age.
  • 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.
  • Life expectancy of <2 years
  • Participant has acute limb ischemia.
  • Previous treatment of the target limb using Drug Coated Balloon (DCB), a stent, or Drug Eluting Stent (DES) within the last 180 days.
Show all 28Show fewer
  • Previous treatment of the contralateral limb using Drug Coated Balloon (DCB) or Drug Eluting Stent (DES) within the last 90 days.
  • History of stroke or TIA within 90 days.
  • History of myocardial infarction (MI), thrombolysis or angina within 30 days of index procedure.
  • 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.
  • Active or suspected active infection at time of index procedure that in the opinion of the investigator should preclude participant enrollment in the study.
  • Patients with any type of previous or planned surgical or interventional procedure within 30 days prior and/or within 30 days post-index procedure.
  • 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 lesion.
  • Known contraindication (including allergic reaction) or sensitivity to sirolimus (rapamycin).
  • 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.
  • Has received systemic immunosuppressants or immune-modifying 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).
  • 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.
  • Has active malignancy prior to study entry.
  • 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).
  • Participant is currently participating in an investigational drug or device study, or previously enrolled in this study. Enrollment in another investigational drug or device study during the follow up period for this study is not allowed.
  • Current alcohol or drug abuse that in the opinion of the investigator should preclude participant enrollment in the study.
  • Participant has a condition that in the opinion of the investigator should preclude participant enrollment in the study.
  • Angiographical Exclusion Criteria:
  • 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.
  • Intended use of adjunctive primary treatment modalities (e.g., atherectomy, laser, cutting balloons, radiation therapy, stents, other drug coated devices.)
  • 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.
  • Pharmacokinetic (PK) Sub-Study:
  • 1. Previous treatment or planned treatment with any Drug Coated Balloon (DCB) or Drug Eluting Stent (DES) in the last 12 months and within 6 months post study index procedure.

Trial locations and contacts

10 sites in 3 countries.

10 sites in 3 countries

Australia6 sites

  • Flinders University

    Adelaide, South Australia, 5001

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • The Alfred

    Melbourne, Victoria, 3004

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • Gold Coast University Hospital

    Southport, Queensland, 4215

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

Other trials in Australia

New Zealand2 sites

  • Auckland City Hospital

    Grafton, Auckland, 1023

  • Waikato Hospital

    Hamilton, Waikato Region, 3204

Other trials in New Zealand

Singapore2 sites

  • Tan Tock Seng Hospital

    Novena, 308433

  • Sengkang General Hospital

    Punggol, 544886

Other trials in Singapore

About this study

Official title: Prospective, Multicenter, Single Arm, Non-Randomized Study of BD Sirolimus Drug Coated Catheter for Treatment of Femoropopliteal Arteries

The objective of this early feasibility study is to assess the safety and performance of the BD™ Sirolimus Drug Coated Balloon Catheter.

Read the detailed description

This is a prospective, multi-center, non-randomized, single-arm early feasibility study designed to assess the safety and performance of the BD™ Sirolimus Drug Coated Balloon Catheter for the treatment of stenosis in the femoropopliteal arteries. Follow-up for all treated subjects will be performed at post-procedure, 30 days, and 6, 12 months, 18 months and 24 months post-index procedure.

Being tested
BD™ Sirolimus Drug Coated Balloon Catheter percutaneous transluminal angioplasty
Medical subject headings
Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BD™ Sirolimus Drug Coated Balloon Catheter percutaneous transluminal angioplastyDevice

    The study will enroll patients presenting with clinical evidence of an angiographically significant lesion (Lesion ≥ 70% stenosis by visual estimate) in the femoropopliteal arteries. Eligible patients will undergo percutaneous transluminal angioplasty with the investigational BD™ Sirolimus Drug Coated Balloon Catheter.

Study groups in NCT05556681
Study groupRoleWhat they receive
Treated with the investigational BD™ Sirolimus Drug Coated CatheterExperimentalPatients treated with the BD™ Sirolimus Drug Coated Catheter
Receives: Device: BD™ Sirolimus Drug Coated Balloon Catheter percutaneous transluminal angioplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Late lumen loss at six months as measured by quantitative vascular angiography (QVA).

    Late lumen loss is defined as the difference (in mm) between the minimum lumen diameter (MLD) of the treated segment at follow up and the measurement immediately after the index procedure.

    Measured: at 6 month follow-up

Secondary outcomes (9)

  1. Rutherford Improvement

    This endpoint will be evaluated by descriptive statistics and will not have statistical analyses associated with them but will be reported upon in the final study report.

    Measured: at discharge, and 1, 6, 12 and 24 month follow-up

  2. Patient Reported Outcome Improvement

    This endpoint will be evaluated by descriptive statistics and will not have statistical analyses associated with them but will be reported upon in the final study report.

    Measured: at post-procedure, and 1, 6, 12 and 24 month follow-up

  3. Freedom of Embolization

    This endpoint will be evaluated by descriptive statistics and will not have statistical analyses associated with them but will be reported upon in the final study report.

    Measured: at discharge, and 1, 6, 12 and 24 month follow-up

  4. ABI Improvement

    This endpoint will be evaluated by descriptive statistics and will not have statistical analyses associated with them but will be reported upon in the final study report.

    Measured: at discharge, and 1, 6, 12 and 24 month follow-up

  5. Revascularization rate (CD-TLR)

    This endpoint will be evaluated by descriptive statistics and will not have statistical analyses associated with them but will be reported upon in the final study report.

    Measured: at discharge, and 1, 6, 12 and 24 month follow-up

  6. Technical & Procedural Success statistical analyses associated with them but will be reported upon in the final study report.

    This endpoint will be evaluated by descriptive statistics and will not have statistical analyses associated with them but will be reported upon in the final study report.

    Measured: at discharge, and 1, 6, 12 and 24 month follow-up

  7. All Cause Death statistical analyses associated with them but will be reported upon in the final study report.

    This endpoint will be evaluated by descriptive statistics and will not have statistical analyses associated with them but will be reported upon in the final study report.

    Measured: at discharge, and 1, 6, 12 and 24 month follow-up

  8. Major Adverse Cardiovascular Events (MACE) statistical analyses associated with them but will be reported upon in the final study report.

    This endpoint will be evaluated by descriptive statistics and will not have statistical analyses associated with them but will be reported upon in the final study report.

    Measured: at discharge, and 1, 6, 12 and 24 month follow-up

  9. Safety Composite statistical analyses associated with them but will be reported upon in the final study report.

    This endpoint will be evaluated by descriptive statistics and will not have statistical analyses associated with them but will be reported upon in the final study report.

    Measured: at discharge, and 1, 6, 12 and 24 month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2022
  2. Study start2 Aug 2022
  3. Primary completion12 Jun 2024
  4. Study completion24 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05556681
Sponsor's protocol ID
BDPI-20-012
Acronym
PREVISION
Status last verified
Dec 2025
First submitted
12 Sep 2022
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No: Data in aggregate

Questions about this trial

What is this clinical trial studying?

A study testing BD™ Sirolimus Drug Coated Balloon Catheter percutaneous transluminal angioplasty in people with Peripheral Arterial Disease and Peripheral Artery Disease, run by C. R. Bard at 10 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Australia, New Zealand, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Late lumen loss at six months as measured by quantitative vascular angiography (QVA). (time frame: at 6 month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05556681.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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