CompletedNot Applicable

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

Australia, New Zealand, Singapore34 participantsStarted 2022-08-02

Plain-language summary

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

Who can participate

Age range

18 Years – 89 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.
. 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.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: at 6 month follow-up

Trial details

NCT IDNCT05556681

SponsorC. R. Bard

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-12

View on ClinicalTrials.gov More Peripheral Arterial Disease trials