BRight Pharmacokinetic Study (NCT06065345) | Clinical Trial Compass
CompletedNot Applicable
BRight Pharmacokinetic Study
Australia6 participantsStarted 2024-05-01
Plain-language summary
The BRight PK Study is a prospective, single-arm, open-label, non-blinded, non-randomized study, which goal is to assess the pharmacokinetic profile of the BRight drug-coated balloon at different time points after the balloon deployment.
The study will enroll a maximum of 10 patients at a single site in Australia
Who can participate
Age range
18 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
. The subject has provided written informed consent
. The subject is willing to participate in the clinical investigation and to comply with the study procedures and follow-up visits
. Lifestyle-limiting claudication or rest pain requiring treatment of superficial femoral (SFA) and/or proximal popliteal artery (PPA)
. Age ≥ 18 years old
. Rutherford-Becker Clinical Category of 2, 3 or 4
. Target vessel reference diameter ≥5 mm and ≤ 6 mm (by visual estimation)
. De novo lesion with \>50% stenosis by operator visual estimate within the SFA and/or proximal popliteal arteries in a single limb.
. Lesion must be located ≥ 1 cm below the Common Femoral Artery (CFA) bifurcation and terminate distally at ≥ 3 cm proximal to the knee joint (radiographic joint space).
Exclusion criteria
. Females who are pregnant, lactating, or intended to become pregnant, or males intending to father children during the study
. Subject under current medication known to affect CYP3A4 metabolism, or consuming food or beverages that are known substrates of CYP3A4
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
1
AUC 0-t
Timeframe: 0 to 24 hours
2
AUC 0-inf
Timeframe: 0 to 24 hours
3
Cmax
Timeframe: 0 to 24 hours
4
Terminal Elimination Rate Constant (λz)
Timeframe: 0 to 24 hours
5
Terminal Elimination Half-life (t1/2)
Timeframe: 0 to 24 hours
6
tmax
Timeframe: 0 to 24 hours
7
Drug clearance (CL)
Timeframe: 0 to 24 hours
8
Apparent volume of distribution at the terminal phase (Vz)
. Subject receiving chronic anticoagulation therapy (e.g. low molecular weight heparin, warfarin, or novel direct oral anticoagulants (N(D)OACs)) if the treatment cannot be interrupted 48 hours prior to the procedure
. Known intolerance to study medications, Limus- like drug or contrast agents that in the opinion of the investigator could not be adequately pretreated
. Current participation in an investigational drug or another device study
. History of hemorrhagic stroke within 3 months
. Patients with a history of Myocardial Infarction (MI) or thrombolysis within 30 days prior-index procedure