BRight Pharmacokinetic Study

NCT06065345 | Completed

• 1 other identifier: C2304
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (9)

• AUC 0-t

  Area under the drug concentration-time curve, calculated using linear trapezoidal summation from time zero to time tlast, where tlast is the time of the last measurable concentration (Ct).

  0 to 24 hours

• AUC 0-inf

  Area under the drug concentration-time curve from time zero to infinity

  0 to 24 hours

• Cmax

  Maximum observed drug concentration

  0 to 24 hours

• Terminal Elimination Rate Constant (λz)

  Apparent terminal elimination rate constant, calculated by linear regression of the terminal linear portion of the log concentration vs. time curve

  0 to 24 hours

• Terminal Elimination Half-life (t1/2)

  Apparent terminal elimination half-life, calculated as ln(2)/λz

  0 to 24 hours

• tmax

  Time of the maximum drug concentration (obtained without interpolation). If the maximum value occurs at more than one time point, tmax is defined as the first time point with this value.

  0 to 24 hours

• Drug clearance (CL)

  Apparent total clearance, calculated as dose/AUC0-inf

  0 to 24 hours

• Apparent volume of distribution at the terminal phase (Vz)

  Apparent volume of distribution at the terminal phase, calculated as CL/λz

  0 to 24 hours

• Metabolic Ratio (MR)

  Metabolic ratio calculated as the molar concentration of sirolimus AUC0-inf to BIOtorcin AUC0-inf

  0 to 24 hours

Secondary Outcomes (14)

• Device success

  during procedure

• Acute technical success

  during procedure

• Acute procedural success

  72 hours post procedure

• Major adverse event (MAE) rate

  1, 6 and 12 months post index procedure

• Clinically-driven Target Lesion Revascularization (cd TLR) rate

  1, 6 and 12 months post index procedure

Study Arms (1)

BRight DCB

EXPERIMENTAL

Single arm study. All subjects will be treated with the BRight DCB

Device: BRight DCB

Interventions

BRight DCB DEVICE

The BRight Drug-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon catheter (BRight DCB) is intended for dilatation of de novo lesions in native superficial femoral or popliteal arteries with a simultaneous release of drug to the vessel wall as a secondary action to reduce occurrence of a restenosis of the treated vessel segment.

BRight DCB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Single lesion length ≤170 mm for de novo stenotic lesions, or ≤ 100 mm for occluded lesions (one long lesion or multiple serial lesions) by operator visual estimate. Notes: (1) Only 1 lesion per patient can be treated. Multiple serial lesions are allowed if they can be treated as a single lesion with a maximum of 2 balloons. (2) a non-occlusive lesion that includes a totally occluded segment along its length are eligible provided that the overall treated lesion length is ≤170 mm (with / or without an occluded segment not greater than 100 mm in length).
• Successful guidewire crossing of lesion.
• After pre-dilatation, the target lesion is ≤ 30% residual stenosis with no flow limiting dissection and treatable with a maximum of 2 balloons.
• Inflow artery is patent, free from significant lesion stenosis (\>50% stenosis considered significant) as confirmed by angiography.
• Note: Where required, inflow iliac arteries (common and external iliac arteries only) must be successfully treated during the index procedure. Completion angiography must confirm successful treatment of inflow disease (≤50% residual stenosis, no distal embolization, and no Grade C or greater dissection) prior to pre-dilatation of the target lesion. Drug-eluting devices are not allowed for treatment of the occluded inflow iliac arteries.
• Patency of the popliteal segments P2 and P3 with at least 1 patent infrapopliteal run-off vessel (that may have a stenosis of less than 50% not interfering with the outflow to the pedal arch) to the ankle in continuity with the native femoropopliteal artery, in the target limb confirmed at baseline. (Note: treatment of outflow disease is permitted. Drug-eluting devices are not allowed for outflow treatment)

You may not qualify if:

• 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
• Contraindication to dual anti-platelet therapy
• 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
• Previous or planned surgical or interventional procedure within 14 days before or 30 days after index procedure (successful treatment of the ipsilateral and contralateral iliac arteries is permitted during the index procedure. Drug-eluting devices are not allowed for treatment of the occluded inflow iliac arteries)
• Prior endovascular treatment of the target lesion (e.g., POBA, DCB, BMS, DES, cutting balloons, scoring balloons, cryoplasty, thrombectomy, atherectomy, brachytherapy or laser devices)
• Previous placement of a bypass graft proximal to the target lesion
• Chronic renal insufficiency (eGFR \< 30 mL/min within 72 hours prior to index procedure)
• Patient requiring renal replacement therapy
• No normal proximal arterial segment in which duplex ultrasound velocity ratios could be measured.
• Subject is unable to walk without assistance (e.g. walker, cane).

Sponsors & Collaborators

• Biotronik CRC Inc.: lead

Study Sites (1)

Royal Perth Hospital

Perth, WAUS, Australia

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: October 3, 2023
• Study Start: May 1, 2024
• Primary Completion: June 27, 2024
• Study Completion: July 22, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)