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 range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
β. The subject has provided written informed consent
β. The subject is willing to participate in the clinical investigation and to comply with the study procedures and follow-up visits
β. Lifestyle-limiting claudication or rest pain requiring treatment of superficial femoral (SFA) and/or proximal popliteal artery (PPA)
β. Age β₯ 18 years old
β. Rutherford-Becker Clinical Category of 2, 3 or 4
β. Target vessel reference diameter β₯5 mm and β€ 6 mm (by visual estimation)
β. De novo lesion with \>50% stenosis by operator visual estimate within the SFA and/or proximal popliteal arteries in a single limb.
β. Lesion must be located β₯ 1 cm below the Common Femoral Artery (CFA) bifurcation and terminate distally at β₯ 3 cm proximal to the knee joint (radiographic joint space).
Exclusion criteria
β. Females who are pregnant, lactating, or intended to become pregnant, or males intending to father children during the study
β. Subject under current medication known to affect CYP3A4 metabolism, or consuming food or beverages that are known substrates of CYP3A4
β. Contraindication to dual anti-platelet therapy
β. 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
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 (Ξ»z)
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)
β. Known intolerance to study medications, Limus- like drug or contrast agents that in the opinion of the investigator could not be adequately pretreated
β. Current participation in an investigational drug or another device study
β. History of hemorrhagic stroke within 3 months
β. Patients with a history of Myocardial Infarction (MI) or thrombolysis within 30 days prior-index procedure